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Lupus Erythematosus, CutaneousPhase 1NCT02927457

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of GSK2646264 in Cutaneous Lupus Erythematosus Subjects

A Phase 1 study testing GSK2646264 1% in people with Lupus Erythematosus, Cutaneous, run by GlaxoSmithKline at 5 sites in Germany.

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 designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by photoprovocation (PV). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lupus Erythematosus, Cutaneous
What is being tested?
GSK2646264 1%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
5 sitesGermany
Study dates
13 Jan 2017to 12 Jun 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 18 and 70 years of age inclusive, at the time of signing the informed consent.
  • Subject values for the following parameters thyroid-stimulating hormone (TSH), free thyroxine (T4), and free triiodothyronine (T3) within the normal range.
  • Subject has confirmed diagnosis of Lupus Erythematosus Tumidus (LET) (group A only), subacute or chronic CLE as determined by the investigators.
  • Body weight >= 50 kg and body mass index (BMI) within the range 19.9 - 35 kilogram (kg)/meter square (m^2) (inclusive)
  • Male OR Female.
  • Females: Non-reproductive potential defined as:
Show all 19Show fewer
  • Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion , Hysterectomy, 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 follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 28 days prior to the first dose of study medication and until 12 days after the last dose of study medication and completion of the follow-up visit.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
  • All subjects must be free from scarring or skin markings (e.g. tattoos or piercings) and open wounds on the defined areas of the body that cream will be applied onto or that will be exposed to PV, unless in the opinion of the investigator it will not compromise the subjects' safety and quality of data.
  • Able to refrain from exposure to extended and direct sunlight during the study period, from screening until follow up, especially the area that is under treatment during the study.
  • Able to refrain from using self-tanning products on the areas on which the study cream will be applied for the duration of the study from screening to follow-up.
  • Able to refrain from shaving and waxing the areas on which the study cream will be applied during the duration of the study from screening to follow up.
  • Patient stable on either no treatment or on :
  • Corticosteroids (=<7.5milligram [mg]/day prednisone or prednisone equivalent or less) for a minimum of 30 days prior to screening and through to Day 28.
  • and /or hydroxychloroquine (=<400mg daily dose) for a minimum of 60 days prior to the initial photoprovocation for group A or Randomisation Visit for group B through to day 28.
  • Topical steroids applied to the defined areas of the body that are not exposed to photoprovocation or study cream from screening to Day 28.
  • Topical calcineurin inhibitors and retinoids applied to the defined areas of the body that are not exposed to photoprovocation or study cream from screening to Day 28.

Who cannot join

  • ALT >2xupper limit of normal (ULN);
  • Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • QTcF > 450 millisecond (msec), or QTcF > 480 msec in subjects with Bundle Branch Block
  • History of any past or present benign or malignant skin conditions and disease, unless in the opinion of the investigator it will not compromise the subjects safety and quality of data.
  • Subjects with a history of Graves disease
Show all 34Show fewer
  • Subjects with a history of thyroid cancer.
  • Unable to refrain from vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half lives (whichever is longer) prior to the screening visit until the completion of the follow-up assessments, unless in the opinion of the Investigator, in consultation with the GlaxoSmithKline (GSK) Medical Monitor if required, the medication will not interfere with the study procedures or compromise subject safety.
  • Clinically significant abnormality in the hematological, clinical chemistry, or urinalysis screen, as judged by the investigator after discussion with the medical monitor.
  • Subjects who start prohibited medications or therapies at any time during the study may be withdrawn from the study. Subjects who start prohibited medications or therapies may remain in the study only with the approval of the Medical Monitor and at the discretion of the Sponsor.
  • The following medications and therapies are prohibited at any time during the study:
  • Use of other investigational agents (biologic or non-biologic; investigational applies to any drug not approved for sale in the country in which it is used).
  • Co-enrolment into another study of an investigational agent or non-drug therapy.
  • Use of biological agents (e.g., alemtuzumab [ATG], rituximab,) during the clinical study or within 12 months to first dose of study treatment.
  • Use of other immunosuppressive drugs commonly used in Systemic lupus erythematosus (SLE) including Azathioprine, Methotrexate, Mycophenolate, Cyclophosphamide within 3 months to first dose of study treatment.
  • History of regular alcohol consumption within 3 months of the study defined as:
  • Alcohol will be allowed but limited to an average weekly intake of <21 units for males or <14 units for females).
  • Direct exposure to ultraviolet (UV) light (e.g. sunbathing) to the testing areas within 2 weeks of study entry.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation (refer to the Investigator Brochure for a list of excipients).
  • Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
  • A positive pre-study drug screen.
  • Where participation in the study would result in donation of blood or blood products in excess of 450 milliliter (ml) within 3 months.
  • 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: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
  • Country Specific Exclusion criteria wording for Germany:
  • Subjects that are employees of either GlaxoSmithKline (sponsor) or one of the study centres (investigators).
  • Subjects who live in detention on court order or on regulatory action.
  • Oral Prednisolone
  • Greater than 7.5 mg by mouth daily.
  • Any increase in dose from screening to Day 28
  • Hydroxychloroquine
  • Greater than 400 mg oral daily.
  • Any increase in dose from screening to Day 28.
  • Photosensitizing drugs within 5 half-lives prior to the photoprovocation visit.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Tübingen, Baden-Wurttemberg, 72076

  • GSK Investigational Site

    Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

About this study

Official title: A Double-blind (Sponsor Unblinded) Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of Repeat Dosing of GSK2646264 in Cutaneous Lupus Erythematosus Patients

This study is designed to examine safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effect of repeat dosing of GSK2646264 in patients with subacute and chronic cutaneous lupus erythematosus (CLE) lesions and in acute CLE like lesions induced by photoprovocation (PV).

Current study is two group study. In Group A, Patients with fewer than two active lesions will be enrolled and exposed to photoprovocation (PV) for 3 consecutive days. Patients that develop PV lesions at any time during this period, as determined by the local investigative team, will receive 1% strength GSK2646264 on 1 lesion and placebo on 1 lesion daily and either 1% strength GSK2646264 or placebo on an area of uninvolved skin, for skin pharmacokinetic (PK) of study drug, for 28 days.

Read more

In Group B, Patients that have a minimum of 2 active existing CLE lesions as determined by the investigators will be enrolled into group B and have one lesion treated with 1% GSK2646264 and 1 lesion with placebo.

A completed patient will be defined as a subject who receives at least 25 days of study drug and completes the end of treatment biopsy (at day 28) and assessment. Thereafter patients will be followed for 28 days in Group A only or until complete resolution of induced PV lesions, as determined by the investigator.

Being tested
GSK2646264 1%, Placebo
Keywords
Cutaneous Lupus Erythematosus-CLE, Spleen Tyrosine Kinase-SYK, Photoprovocation-PV, GSK2646264
Medical subject headings
Lupus Erythematosus, Cutaneous

What participants receive

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

  • GSK2646264 1%Drug

    A cream for topical application with a concentration of 1% GSK2646264.

  • PlaceboDrug

    Subjects will receive matching Placebo topically.

Study groups in NCT02927457
Study groupRoleWhat they receive
Group A1- Skin Sites A/C/D (A/P/A)ExperimentalSkin areas A to E in group A are identified skin areas across the back of the subject. Subjects will be receiving GSK2646264 1% (A) for Area A- PV lesion, Placebo (P) for Area C- PV lesion and GSK2646264 1% for Area D- uninvolved skin once daily for 28 days according to randomisation. Skin areas B- PV lesion and E- uninvolved skin will not be assigned any treatment and will be used for the baseline biopsy.
Receives: Drug: GSK2646264 1%; Drug: Placebo
Group A2- Skin Sites A/C/D (A/P/P)ExperimentalSkin areas A to E in group A are identified skin areas across the back of the subject. Subjects will be receiving GSK2646264 1% for Area A- PV lesion, Placebo for Area C- PV lesion and Placebo for Area D- uninvolved skin once daily for 28 days according to randomisation. Skin areas B- PV lesion and E- uninvolved skin will not be assigned any treatment and will be used for the baseline biopsy.
Receives: Drug: GSK2646264 1%; Drug: Placebo
Group A3- Skin Sites A/C/D (P/A/A)ExperimentalSkin areas A to E in group A are identified skin areas across the back of the subject. Subjects will be receiving Placebo for Area A- PV lesion, GSK2646264 1% for Area C- PV lesion and GSK2646264 1% for Area D- uninvolved skin once daily for 28 days according to randomisation. Skin areas B- PV lesion and E- uninvolved skin will not be assigned any treatment and will be used for the baseline biopsy.
Receives: Drug: GSK2646264 1%; Drug: Placebo
Group A4- Skin Sites A/C/D (P/A/P)ExperimentalSkin areas A to E in group A are identified skin areas across the back of the subject. Subjects will be receiving Placebo for Area A- PV lesion, GSK2646264 1% for Area C- PV lesion and Placebo for Area D- uninvolved skin once daily for 28 days according to randomisation. Skin areas B- PV lesion and E- uninvolved skin will not be assigned any treatment and will be used for the baseline biopsy.
Receives: Drug: GSK2646264 1%; Drug: Placebo
Group B1- Skin Sites F/ G (A/P)ExperimentalIn group B, two chosen lesions will be labeled F and G based on size (F >G). Subjects will be receiving GSK2646264 1% for lesion F and Placebo for lesion G once daily for 28 days according to randomisation. Skin area H- uninvolved skin will not be assigned any treatment and will be used for the baseline biopsy.
Receives: Drug: GSK2646264 1%; Drug: Placebo
Group B2- Skin Sites F/ G (P/A)ExperimentalIn group B, two chosen skin lesions will be labeled F and G based on size (F >G). Subjects will be receiving Placebo for lesion F and GSK2646264 1% for lesion G once daily for 28 days according to randomisation. Skin area H- uninvolved skin will not be assigned any treatment and will be used for the baseline biopsy.
Receives: Drug: GSK2646264 1%; Drug: Placebo

What is being measured

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

  1. Number of Participants With Emergent Chemistry Results by Potential Clinical Importance (PCI) Criteria

    Blood samples were collected to analyze the clinical chemistry parameters; albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), calcium, glucose, potassium (Pot) and sodium. PCI ranges were albumin (low: <30 grams per liter), calcium (low: <2 millimoles per liter [mmol/L] and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L), sodium (low: <130 mmol/L and high: >150 mmol/L), ALT (high: >=2 times upper limit of normal [ULN] units per liter {U/L}), AST (high: >=2 times ULN U/L), ALP (high: >=2 times ULN U/L) and TB (high: >=1.5 times ULN micromoles per liter). Safety Population comprised of all participants who received at least one dose of study treatment. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Day 14, Day 28 and follow-up (up to Day 56)

  2. Number of Participants With Emergent Hematology Results by PCI Criteria

    PCI ranges were hematocrit [Hct] (high: >0.54 proportion of red blood cell [RBC] in blood), hemoglobin [Hb] (high: >180 grams per liter), RBC (low: <4.2x10^12 cells per liter and high: >5.9x10^12 cells per liter), lymphocytes [Lympho] (low: <0.8x10^9 cells per liter), monocytes [Mono] (low: <0.14x10^9 cells per liter and high: >1.3x10^9 cells per liter), neutrophils [Neutro] (low: <1.5x10^9 cells per liter), platelet count [PC] (low: <100x10^9 cells per liter and high: >550x10^9 cells per liter), eosinophils [Eos] (high: >0.55x10^9 cells per liter), basophils [Baso] (high: >0.22x10^9 cells per liter), white blood cell [WBC] (low: <3x10^9 cells per liter and high: >20x10^9 cells per liter). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Day 14, Day 28 and follow-up (up to Day 56)

  3. Change From Baseline in Urine Potential of Hydrogen (pH)

    Urine samples were collected to monitor the pH. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower number indicates the more acidic urine. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)

  4. Change From Baseline in Urine Specific Gravity

    Urine samples were collected to monitor the specific gravity. Specific gravity is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)

  5. Number of Participants With Emergent Vital Sign Results by PCI Criteria

    Vital signs such as diastolic blood pressure (DBP), heart rate (HR) and systolic blood pressure (SBP) were measured in semi-supine position after 5 minutes rest for the participants. PCI ranges were SBP (lower: <85 millimeters of mercury [mmHg] and upper: >160 mmHg), DBP: (lower: <45 mmHg and upper: >100 mmHg) and HR (lower: <40 beats per minute [bpm] and upper: >110 bpm). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Day 14 and Day 28

  6. Change From Baseline in Electrocardiogram (ECG); HR

    Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Baseline (Day 1), Day 14 and follow-up (up to Day 56)

  7. Change From Baseline in ECG; PR Interval, QRS Duration, QT Interval and QTcF

    Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.

    Measured: Baseline (Day 1), Day 14 and follow-up (up to Day 56)

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

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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 persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function.

    Measured: Up to Day 56

Secondary outcomes (4)

  1. Change From Baseline in Erythema, Scaling Hyperkeratosis, Edema/Infiltration, Dyspigmentation, Modified Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) Activity Score and Overall RCLASI Modified Score.

    The score ranges for different components were; erythema [0 (absent) to 3 (dark red, purple/violaceous/crusted/hemorrhagic)], scaling/hyperkeratosis [0 (absent) to 2 (verrucous hyperkeratosis)], edema/infiltration [0 (absent) to 2 (palpable and visible)] and dyspigmentation [0 (absent) to 2 (hypo and hyper pigmentation)]. For all components, 0 (better) and 3 (worse). Modified RCLASI activity score was derived by adding score for erythema, scaling hyperkeratosis and edema/infiltration. Modified change from Baseline ranged from -7 to 7, 0 (no change), minus (better) and positive (worse). Overall RCLASI modified score was derived by summing the activity and dyspigmentation scores. Overall change from Baseline ranged from -9 to 9, 0 (no change), minus (better) and positive (worse). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data was not collected for Group A as no participants were dosed.

    Measured: Baseline (Day 1), Day 14 and Day 28

  2. Maximum Observed Concentration (Cmax) of GSK2646264 in Participants With Cutaneous Lupus Erythematosus (CLE)

    Blood samples were collected at designated timepoints and pharmacokinetic (PK) analysis was performed. Cmax was calculated by non-compartmental analysis using WinNonlin. PK Population comprised of all participants in the safety population for whom a PK sample was obtained and analyzed.

    Measured: Day 1 (pre-dose and 5 hours post-dose), Day 2 to Day 13, Day 14 (pre-dose), Day 21 to Day 27, Day 28 (post-dose), Day 29 to Day 42 and Follow-up (up to Day 56)

  3. Time to Reach Maximum Observed Concentration (Tmax) of GSK2646264 in Participants With CLE

    Blood samples were collected at designated timepoints and PK analysis was performed. Tmax was calculated by non-compartmental analysis using WinNonlin.

    Measured: Day 1 (pre-dose and 5 hours post-dose), Day 2 to Day 13, Day 14 (pre-dose), Day 21 to Day 27, Day 28 (post-dose), Day 29 to Day 42 and Follow-up (up to Day 56)

  4. Mean Fold Change in Messenger Ribonucleic Acid (mRNA) Expression of Interferon (IFN) Signatures in Skin Biopsies

    Microarray mRNA data was collected from the skin biopsy in both GSK2646264 and placebo treated lesions on Day -5 to -3 visit (Baseline) and Day 28. Fold change represents the change at Day 28 relative to Baseline for each treatment group. Analysis was conducted using mixed model with participant as a random effect and treatment as a fixed effect where treatment is set to "not applicable" at Baseline. Mean fold change and 95% confidence interval is presented for different genes and probesets. IFI16 indicated interferon, gamma-inducible protein 16, IFI44 indicated interferon-induced protein 44, IFIH1 indicated interferon induced with helicase C domain 1, IFIT1 and 3 indicated interferon-induced protein with tetratricopeptide repeats 1 and 3, MX1 indicated myxovirus (influenza virus) resistance 1, interferon-inducible protein p78 (mouse), MX2 indicated myxovirus (influenza virus) resistance 2 (mouse) and OAS indicated 2'-5'-oligoadenylate synthetase.

    Measured: Baseline (Day -5 to -3) and Day 28

Timeline

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

  1. First posted7 Oct 2016 (estimated)
  2. Study start13 Jan 2017
  3. Primary completion12 Jun 2018
  4. Study completion12 Jun 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
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927457
Sponsor's protocol ID
204860
Other IDs
2016-000277-20, 2016
Status last verified
Mar 2021
First submitted
30 Aug 2016
Last updated
8 Apr 2021
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Walker A, Erwig L, Foster K, Nevin K, Wenzel J, Worm M, Williams N, Ratia N, Hoang B, Schneider-Merck T, Gisbert S, Carnarius H, Dickson M. Safety, pharmacokinetics and pharmacodynamics of a topical SYK inhibitor in cutaneous lupus erythematosus: A double-blind Phase Ib study. Exp Dermatol. 2021 Nov;30(11):1686-1692. doi: 10.1111/exd.14253. Epub 2020 Dec 17.

    PubMed 33336508

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2646264 1% in people with Lupus Erythematosus, Cutaneous, run by GlaxoSmithKline at 5 sites in Germany.

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 19 inclusion and 34 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. 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 26 Jul 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 Emergent Chemistry Results by Potential Clinical Importance (PCI) Criteria (time frame: Day 14, Day 28 and follow-up (up to Day 56)). The study lists 8 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 NCT02927457, 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 8 Apr 2021.

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