AzTrials
AzTrials

PsoriasisPhase 1NCT02195349

A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis

A Phase 1 study testing GSK2831781 in people with Psoriasis, run by GlaxoSmithKline at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific to the Lymphocyte Activation Gene-3… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
GSK2831781
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
3 sitesin 2 countries
Study dates
30 Jul 2014to 7 Mar 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part A males aged between 18 and 65 years of age and Part B males and females aged between 18 and 75 years of age inclusive, at the time of signing the informed consent
  • Part A: A body weight <=120 kilogram (kg) and Body mass index (BMI) within the range 19-32 kg/square meter (m^2) (inclusive), Part B: BMI within range 19-35 kg/m^2 (inclusive).
  • Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
  • Based on single or averaged Electrocardiogram QT interval corrected for heart rate (QTc) values of triplicate Electrocardiogram (ECGs) obtained over a brief recording period: Electrocardiogram QT interval corrected for heart rate using Fridericia's formula (QTcF) <450 milliseconds (msec)
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • For Part A study subjects only
Show all 18Show fewer
  • Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the Glaxosmithkline (GSK) Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
  • Delayed type hypersensitivity (DTH) cohorts only
  • Subjects with a history of Bacillus Calmette Guérin (BCG) vaccination as evidence by either: A BCG scar and verbal confirmation of BCG vaccination ; Or documented medical history of a BCG vaccination with or without a BCG scar
  • Subjects with a history of current vaccination for Tetanus, diphtheria, measles, pertussis, mumps and rubella
  • For Part B study subjects only
  • Subject has psoriasis covering Body Surface Area (BSA) >=3 percent as assessed at Screening and Day-1
  • Subject has had a confirmed diagnosis of chronic plaque-type psoriasis (without recent documented flare within 30 days prior to screening) for at least 6 months
  • Subject has at least 2 stable plaques assessed at Screening and Day -1. One of a suitable size and in a site suitable for repeat biopsy, and one for index lesion Plaque Lesional Severity Score (PLSS) scoring. Both must have a PLSS lesional score of >=2 for the induration component (moderate or above), >=1 for erythema and scaling with a total score of >=5. The biopsy lesion must not be on the face, groin or scalp and must be protected from the sun
  • A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and negative urine hCG test at Day -1 for Females of Reproductive Potential [FRP]), not lactating, and at least one of the given conditions applies: Non-reproductive potential defined as pre-menopausal females with a documented tubal ligation; or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; or hysterectomy; or documented bilateral oophorectomy.
  • Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
  • Reproductive potential and agrees to use a barrier method (male condom or female diaphragm) plus to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP from 28 days prior to the first dose of study medication and until completion of the follow-up visit.
  • The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. The investigator or designee should remind the subjects of the need to comply with these requirements approximately monthly, either at study visits or by telephone call until the follow-up visit.

Who cannot join

  • Received live vaccine (s) attenuated or recombinant within 4 weeks of Day 1 or plan to receive a live vaccination during the study until follow-up
  • Subjects from a high risk area of the world for tuberculosis or have history of tuberculosis or have close family members with confirmed Mycobacterium tuberculosis (MTB) infection or positive at screening by Quantiferon testing
  • Subject is unable to abstain from travelling to areas with high endemic rates of infectious diseases until the end of the follow up period
  • A medical history of severe allergic reaction, angio-edema, anaphylaxis or immunodeficiency
  • Subjects with neutrophil results below the normal range at screening and baseline
  • Subjects with any clinical, even mild, Gastrointestinal (GI) upset such as, but not limited to, diarrhea or abdominal cramping during the previous week before dosing, as well as history of more chronic GI upset, e.g. Irritable Bowel Syndrome (IBS)
Show all 38Show fewer
  • Current evidence of ongoing or acute infection within 3 months prior to the first dose of study drug, such as: Serious local infection (e.g. cellulitis, abscess); Systemic infection [e.g. pneumonia, septicaemia, Tuberculosis (TB)]
  • Subjects who test positive for pre-existing ADA to GSK2831781 at screening.
  • History of malignancy, except for basal cell or squamous cell carcinoma, or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
  • History of sensitivity to any of the study medications or Tuberculin Purified Protein Derivative (PPD) challenge agent, or components thereof or a history of drug (or Immunoglobulin G therapeutic antibodies) or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive pre-study drug/alcohol screen
  • A positive test for Human Immunodeficiency Virus (HIV) antibody
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day
  • Subjects with an aspartate aminotransferase and/or gamma glutamyltransferase level above the upper limit of normal at screening and/or baseline will be excluded
  • For Part A study subjects only
  • Use of prescription drugs or non-prescription drugs, if in the opinion of the investigator (in consultation with the GSK medical monitor), the medication will interfere with the study procedures or compromise subject safety
  • Subjects must not currently be taking any of the following: topical steroids on the arms, oral or systemic steroids or any other immune-modulators (the washout period will be determined, on a case by case basis, by the investigator in consultation with the GSK medical monitor)
  • Subjects with an aspartate aminotransferase and/or gamma glutamyltransferase level above the upper limit of normal at screening and/or baseline will be excluded.
  • For Part A (only cohorts with DTH challenge) study subjects only:
  • Use of nicotine patches on the arm at screening that would interfere with the injection sites
  • Presence of tattoos, naevi or other skin abnormalities such as keloids (or a history of keloids) that may, in the opinion of the investigator, interfere with DTH assessments
  • Subjects participating, within seven days of screening, in recreational sun-bathing, or the use of a sun-bed, on the area of the skin from the wrist to the shoulder (inclusive)
  • For Part B study subjects only:
  • History of significant cardiac, endocrinologic, haematologic, pulmonary, metabolic, renal, hepatic, immunologic (excluding psoriasis and psoriatic arthritis), urologic, neurologic, dermatologic (except psoriasis), psychiatric or gastrointestinal conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at unacceptable risk
  • Clinically significant abnormalities of laboratory assessments (not related to disease) as judged by the investigator and/or GSK medical monitor
  • All systemic psoriasis medications, including psoralen long-wave ultraviolet radiation treatments, or other systemic immunosuppressives, are not allowed within 5 half lives prior to Day-1 (Methotrexate and cyclosporin are not allowed within 8 weeks of Day -1; Psoralen long-wave Ultraviolet (UV) is not allowed within 4 weeks of Day-1). Subjects should not be included if the investigator considers that the subject is at high risk of requiring rescue with prohibited medication for duration of study up to follow-up. This assessment should be based on current disease activity or a history of frequent and/or severe flares requiring systemic immunosuppression.
  • The use of single treatment phototherapy (ultraviolet B or self treatment with tanning beds) is not allowed within 14 days prior to Day -1
  • The use of topical therapies for psoriasis are not allowed with 7 days prior to Day-1 on the index lesion or biopsy plaque
  • Previous treatment with anti- Tumour necrosis factor (TNF)/ Interleukin (IL)-12/IL-23 or any other monoclonal antibodies is not allowed within 12 weeks prior to Day-1
  • Patients that require narrow therapeutic index medications from Screening to Follow-up
  • Vulnerable subjects (e.g. person kept in detention)
  • Subjects who are not able to understand and communicate in the native language of the country where the study is conducted.
  • Subjects who work for the Sponsor or CRO.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Germany2 sites

  • GSK Investigational Site

    Berlin, 14050

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

Other trials in Germany

United Kingdom1 site

  • GSK Investigational Site

    London

Other trials in United Kingdom

About this study

Official title: A Randomised, Double Blind (Sponsor Unblinded), Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a IV Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis

This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV. GSK2831781 is a humanized Antibody Dependent Cell Cytotoxicity (ADCC) enhanced monoclonal afucosylated antibody that is specific to the Lymphocyte Activation Gene-3 (LAG-3) protein. This is the first administration of GSK2831781 in humans and will evaluate in two parts the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single IV doses of GSK2831781 administered to healthy subjects previously vaccinated with Bacillus Calmette Guérin (BCG) (Part A delayed type hypersensitivity [DTH] cohorts) and patients with plaque psoriasis (Part B). The inclusion of DTH and psoriasis subjects to explore the mechanism in biopsies and clinical response endpoints in these populations, as well as investigate systemic biomarkers will provide useful information prior to conducting studies in other immune-inflammatory disease which will involve more invasive tissue biopsies. Measuring the pharmacology of GSK2831781 using the depletion of LAG-3+ T-cells in skin biopsies from Tuberculin Purified Protein Derivative (PPD) skin challenge and lesional skin biopsies from patients with psoriasis, will be helpful in understanding of the dose response relationship, which will be important for designing future studies in immuno-inflammatory diseases, including psoriasis. Approximately 67 subjects will be enrolled to complete dosing and critical assessments. The subject numbers will be split to approximately 40 healthy subjects (Part A) and 27 patients with psoriasis (Part B).

Conditions
Psoriasis
Being tested
GSK2831781, Placebo
Keywords
Tuberculin Purified Protein Derivative, Delayed Type Hypersensitivity, Biopsy, Induration, First time in human, T-cells, LAG-3, safety, GSK2831781, psoriasis
Medical subject headings
Psoriasis, Hypersensitivity, Delayed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK2831781Biological

    GSK2831781 (100 milligram (mg)/mL) and its dilutions (Diluent - 0.9 percent saline solution containing 0.015 percent Polysorbate 80) as clear or opalescent, colourless, yellow to brown liquid solution administered by IV over approximately 2 hours.

  • PlaceboBiological

    Commercial saline solution administered by IV over approximately 2 hours

Study groups in NCT02195349
Study groupRoleWhat they receive
Healthy Subjects (no DTH)ExperimentalOne subject will be dosed with GSK2831781 (0.0003 mg/kg) and one with placebo. Depending on the safety data obtained for 28 days post dose along with the available PK data, a dose escalation may be done to the next planned dose (0.0015 , 0.0075, 0.04, 0.15 mg/kg). In case safety findings are noted then the cohort may be expanded to a maximum cohort size of 6:3 (GSK2831781: placebo) or the escalation will be stopped.
Receives: Biological: GSK2831781; Biological: Placebo
Healthy Subjects (DTH)ExperimentalSentinel subjects (one dosed with GSK2831781 (0.0003 mg/kg) and one with placebo) will be used in the cohort. Following a review of safety data up to 48 hours post dose, an additional 5 active (GSK2831781) and 1 placebo subject will be dosed (no more than 2 subjects per day with dosing separated by at least 1 hour). After reviewing the safety data for 28 days the healthy subjects (DTH) will be escalated to the planned dose of GSK2831781 (0.0075, 0.04, 0.15 mg/kg) in 6:3 ratio with placebo.
Receives: Biological: GSK2831781; Biological: Placebo
Subjects with PsoriasisExperimentalSentinel subjects (one dosed with GSK2831781 and one with placebo) will be used in the cohort. Following a review of safety data up to 48 hours post dose, an additional 5 active (GSK2831781) and 2 placebo subjects will be dosed (no more than 2 subjects per day with dosing separated by at least 1 hour). All subsequent cohorts do not require stratification for pre-existing ADAs. After reviewing the safety data for 28 days for minimum of 8 out of 9 subjects within the cohort and all subjects have completed dosing and the inpatient monitoring until Day 4, the subjects with psoriasis will be escalated to the planned dose of GSK2831781 (1.5 and 5 mg/kg) in 6:3 ratio with placebo.
Receives: Biological: GSK2831781; Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)

    Hematology parameters with PCI ranges: hematocrit (high: >0.54 percentage of red blood cells), hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8*giga cells per liter [10^9/L]), neutrophil count (low: <1.5*10^9/L), platelet count (low: <100*10^9/L and high: >550*10^9/L), and while blood cell count (low: <3*10^9/L and high: >20*10^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.

    Measured: Up to 307 days

  2. Number of Participants With Clinical Chemistry Abnormalities of PCI

    Clinical chemistry parameters and their potential clinical concern values: albumin (low: <30 millimoles per liter [mmol/L]), calcium (low: <2 mmol/L, high: >2.75 mmol/L), creatinine (high: >44.2 mmol/L), glucose (low: <3 mmol/L, high: >9 mmol/L), magnesium (low: <0.5 mmol/L, high: >1.23 mmol/L), phosphorus (low: <0.8 mmol/L, high: >1.6 mmol/L), potassium (low: <3 mmol/L, high: >5.5 mmol/L), sodium (low: <130 mmol/L, high: >150 mmol/L), and total carbon dioxide (CO2) (low: <18 mmol/L, high: >32 mmol/L). Number of participants with clinical chemistry of PCI are presented.

    Measured: Up to 307 days

  3. Number of Participants With Vital Signs of PCI

    Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: <40 beats per minute [BPM] and high: >110 BPM), systolic blood pressure (low: <85 and high: >160 millimeter of mercury [mmHg]), diastolic blood pressure (low: <45 mmHg and high: >100 mmHg) and body temperature (low: <35 degree Celsius and high: >37.5 degree Celsius). Number of participants with vital signs of PCI are presented.

    Measured: Up to 307 days

  4. Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI

    Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: >450 millisecond [msec]), PR Interval (low: <110 msec and high: >220 msec) and QRS Interval (low: <75 msec and high: >110 msec). Number of participants with ECG values of PCI are presented.

    Measured: Up to 307 days

  5. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

    Measured: Up to 307 days

  6. Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha

    IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Baseline, 6, 12, 24 and 48 hours post-dose

  7. Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191

  8. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Day 15 and 29

  9. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 29 and 43

  10. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85

  11. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147

  12. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219

  13. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191

  14. Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307

  15. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237

  16. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277

  17. Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg

    Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

    Measured: 6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307

Secondary outcomes (119)

  1. Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose

    The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.

    Measured: Baseline, Days 4, 8, 15 and 22 post-dose

  2. Duration of Induration in the Re-challenge for DTH

    The duration of induration was the time (in days) to achieve an overall induration less than 6 mm from the time of the PPD re-challenge post-dose. Duration of induration was calculated as: PPD re-challenge post-dose up to the last available induration measurement. Data is presented for DTH participants.

    Measured: Up to 28 days post-dose

  3. Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose

    A punch biopsy was taken from one of the challenge sites. Cells in biopsies of re-challenged skin were measured by immunohistochemistry (IHC) and the LAG-3+ cells characterized and counted. Baseline was considered as Day -26 for this outcome measure. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.

    Measured: Baseline and 72 hours post-dose

  4. Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29

    A punch biopsy was taken from active leading edge of the lesion. Cells in lesional biopsies of skin were measured by IHC and count the LAG-3+ cells. The regions of interest for LAG3+ were located in epidermis and dermis. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Baseline and Day 29

  5. Area Under the Plasma Time Curve From Zero to Infinity (AUC[0-infinity]) of GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma. Pharmacokinetic (PK) population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  6. AUC(0-infinity) for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  7. AUC(0-infinity) for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  8. AUC(0-infinity) for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  9. AUC(0-infinity) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  10. AUC(0-infinity) for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  11. AUC(0-infinity) for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  12. AUC(0-infinity) for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  13. Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  14. AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  15. AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  16. AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  17. AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  18. AUC(0-t) for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  19. AUC(0-t) for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  20. AUC(0-t) for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  21. Area Under the Concentration-time Curve From Zero (Pre-dose) to Week 4 (AUC[0-Week 4]) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24 and 696 (Week 4) hours post-dose

  22. AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 696 (Week 4) hours post-dose

  23. AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15 and 29 (Week 4) post-dose

  24. AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time point for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22 and 29 (Week 4) post-dose

  25. AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

  26. AUC(0-Week 4) for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

  27. AUC(0-Week 4) for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time point for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

  28. AUC(0-Week 4) for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

  29. Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  30. %AUCex for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  31. %AUCex for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  32. %AUCex for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  33. %AUCex for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  34. %AUCex for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  35. %AUCex for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  36. %AUCex for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  37. Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  38. Cmax for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  39. Cmax for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  40. Cmax for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  41. Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  42. Cmax for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  43. Cmax for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  44. Cmax for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  45. Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  46. Tmax for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  47. Tmax for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  48. Tmax for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  49. Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  50. Tmax for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  51. Tmax for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  52. Tmax for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  53. Time of Last Quantifiable Concentration (Tlast) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  54. Tlast for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  55. Tlast for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  56. Tlast for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  57. Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  58. Tlast for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  59. Tlast for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  60. Tlast for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  61. Systemic Clearance of Parent Drug (CL) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  62. CL for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  63. CL for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  64. CL for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  65. CL for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  66. CL for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  67. CL for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  68. CL for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  69. Volume of Distribution at Steady State (Vss) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  70. Vss for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  71. Vss for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  72. Vss for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  73. Vss for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  74. Vss for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  75. Vss for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  76. Vss for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  77. Mean Residence Time (MRT) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  78. MRT for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  79. MRT for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  80. MRT for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  81. MRT for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  82. MRT for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  83. MRT for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  84. MRT for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  85. Terminal Elimination Rate (Lambda z) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  86. Lambda z for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  87. Lambda z for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  88. Lambda z for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  89. Lambda z for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  90. Lambda z for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  91. Lambda z for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  92. Lambda z for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  93. Terminal Phase Half-life (t1/2) for GSK2831781 0.0003 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

  94. t1/2 for GSK2831781 0.0015 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

  95. t1/2 for GSK2831781 0.0075 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

  96. t1/2 for GSK2831781 0.04 mg/kg (ADA-ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

  97. t1/2 for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

  98. t1/2 for GSK2831781 0.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

  99. t1/2 for GSK2831781 1.5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

  100. t1/2 for GSK2831781 5 mg/kg

    Blood samples were collected at specified time points for GSK2831781 in plasma.

    Measured: Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

  101. Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)

  102. Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, and follow-up (Day 29)

  103. Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 43)

  104. Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 85)

  105. Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 147)

  106. Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 219)

  107. Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)

  108. Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)

  109. Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 237)

  110. Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 277)

  111. Number of Participants With Positive ADAs to GSK2831781 5 mg/kg

    Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

    Measured: Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)

  112. Change From Baseline in Psoriasis Area Severity Index (PASI) Scores

    PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  113. Actual PASI Scores

    PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score).

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  114. Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score

    PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  115. Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque

    PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. A negative change from Baseline is an improvement in symptoms.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  116. Absolute PLSS Scores for the Index Plaque

    PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  117. Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants

    A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  118. Absolute PGA Scores in Psoriasis Participants

    A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

  119. Percentage of Participants in Each PGA Score Category

    A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0=clear, 1=almost clear, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.

    Measured: Baseline, Days 15, 29, 43, 85 and 121

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study start30 Jul 2014
  3. Primary completion7 Mar 2018
  4. Study completion7 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195349
Sponsor's protocol ID
200630
Other IDs
2014-000312-33, 2014
Status last verified
Feb 2021
First submitted
17 Jul 2014
Last updated
25 Mar 2021
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Ellis J, J B Marks D, Srinivasan N, Barrett C, Hopkins TG, Richards A, Fuhr R, Albayaty M, Coenen M, Liefaard L, Leavens K, Nevin KL, Tang S, Hughes SA, Fortunato L, Edwards K, Cui Y, Anselm R, Delves CJ, Charles E, Feeney M, Webb TM, Brett SJ, Schmidt TS, Stone J, Savage COS, Wisniacki N, Tarzi RM. Depletion of LAG-3+ T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781. Clin Pharmacol Ther. 2021 May;109(5):1293-1303. doi: 10.1002/cpt.2091. Epub 2020 Nov 24.

    PubMed 33113155

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2831781 in people with Psoriasis, run by GlaxoSmithKline at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI) (time frame: Up to 307 days). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195349, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT02195349 | AzTrials