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PsoriasisPhase 2NCT02564042

A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis

A Phase 2 study testing GSK2894512 1% Cream and GSK2894512 0.5% Cream in people with Psoriasis, run by GlaxoSmithKline at 46 sites in 3 countries.

Completed

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

Official record
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Trial summary

This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Psoriasis
What is being tested?
GSK2894512 1% Cream and GSK2894512 0.5% Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
46 sitesin 3 countries
Study dates
23 Nov 2015to 5 Oct 2016
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female between 18 to 65 years of age inclusive, at the time of signing the informed consent.
  • Confirmed clinical diagnosis of chronic stable plaque psoriasis for >=6 months.
  • Body surface area involvement >=1% and <=15%, excluding scalp, at Screening and Baseline.
  • A PGA of psoriasis score >=2 at Baseline.
  • One target plaque located on the trunk or proximal parts of extremities (excluding knees, elbows, and intertriginous areas) that is at least 3 (centimetre) cm х 3 cm in size at Screening and Baseline with a severity representative of the subject's overall disease.
  • A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: 1) Pre-menopausal females with one of the following procedures documented: tubal ligation; hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; bilateral oophorectomy. 2) Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause and falling into the central laboratory's postmenopausal reference range is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt are 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 from 30 days prior to the first dose of study medication and until (at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer) after the last dose of study medication and completion of the follow-up visit.

Who cannot join

  • Any sign of infection of any of the psoriatic lesions.
  • A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
  • Known hypersensitivity to the study treatment excipients, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation.
  • Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen, or positive hepatitis C antibody test result within 3 months of screening.
  • Liver function tests: alanine aminotransferase >=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • QTc >=450 milliseconds (msec) or QTc >=480 msec for subjects with bundle branch block.
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  • NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged.
  • Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's psoriasis.
  • Used any of the following treatments within the indicated washout period before the baseline visit: 1) 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 24 weeks for alefacept, 12 weeks for etanercept, 15 weeks for ustekinumab); 2) 12 weeks - oral retinoids (eg, acitretin or isotretinoin); 3) 8 weeks - cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus UVA light treatment; 4) 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 5) 2 weeks - immunizations; drugs known to possibly worsen psoriasis, such as beta-blockers (eg, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for >12 weeks; 6) 2 weeks - topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body).
  • Participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
  • History of alcohol or other substance abuse within the last 2 years.
  • Participated in a previous study using GSK2894512 (or WBI-1001).

Trial locations and contacts

46 sites in 3 countries.

46 sites in 3 countries

United States18 sites

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Fort Gratiot Township, Michigan, 48059

  • GSK Investigational Site

    Goodlettsville, Tennessee, 37072

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Houston, Texas, 77004

  • GSK Investigational Site

    Johnston, Rhode Island, 02919

  • GSK Investigational Site

    Louisville, Kentucky, 40217

  • GSK Investigational Site

    Miami, Florida, 33142

  • GSK Investigational Site

    North Logan, Connecticut, 06032

  • GSK Investigational Site

    Overland Park, Kansas, 66215

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19103

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Plainfield, Indiana, 46168

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    Seattle, Washington, 98101

  • GSK Investigational Site

    Webster, Texas, 77598

Other trials in United States

Japan15 sites

  • GSK Investigational Site

    Fukuoka, 813-0044

  • GSK Investigational Site

    Fukuoka, 819-0373

  • GSK Investigational Site

    Hokkaido, 006-0022

  • GSK Investigational Site

    Hokkaido, 066-0021

  • GSK Investigational Site

    Hokkaido, 066-0064

  • GSK Investigational Site

    Kanagawa, 221-0825

  • GSK Investigational Site

    Kumamoto, 861-3101

  • GSK Investigational Site

    Osaka, 572-0838

  • GSK Investigational Site

    Osaka, 593-8324

  • GSK Investigational Site

    Tokyo, 133-0057

  • GSK Investigational Site

    Tokyo, 136-0074

  • GSK Investigational Site

    Tokyo, 190-0023

  • GSK Investigational Site

    Tokyo, 194-0013

  • GSK Investigational Site

    Tokyo, 195-0053

  • GSK Investigational Site

    Tokyo, 203-0003

Other trials in Japan

Canada13 sites

  • GSK Investigational Site

    Hamilton, Ontario, L8N 1V6

  • GSK Investigational Site

    Markham, Ontario, L3P1X2

  • GSK Investigational Site

    Montreal, Quebec, H2K 4L5

  • GSK Investigational Site

    North Bay, Ontario, P1B 3Z7

  • GSK Investigational Site

    Oakville, Ontario, L6J 7W5

  • GSK Investigational Site

    Ottawa, Ontario, K2G 6E2

  • GSK Investigational Site

    Peterborough, Ontario, K9J5K2

  • GSK Investigational Site

    Québec, Quebec, G1V4X7

  • GSK Investigational Site

    Richmond Hill, Ontario, L4B 1A5

  • GSK Investigational Site

    Surrey, British Columbia, V3R 6A7

  • GSK Investigational Site

    Waterloo, Ontario, N2J 1C4

  • GSK Investigational Site

    Windsor, Ontario, N8W 1E6

  • GSK Investigational Site

    Windsor, Ontario, N8W 5L7

Other trials in Canada

About this study

Official title: Study 203120: A Randomized, Blinded, Vehicle-Controlled, Dose-Finding Study of GSK2894512 Cream for the Treatment of Plaque Psoriasis

This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adult males and females subjects with plaque psoriasis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.

Conditions
Psoriasis
Being tested
GSK2894512 1% Cream, GSK2894512 0.5% Cream, Vehicle cream
Keywords
Double blind, Dose-finding, Vehicle-Controlled, GSK2894512, Plaque Psoriasis
Medical subject headings
Psoriasis

What participants receive

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

  • GSK2894512 1% CreamDrug

    1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically

  • GSK2894512 0.5% CreamDrug

    0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically

  • Vehicle creamDrug

    White to off-white vehicle cream base to be applied topically

Study groups in NCT02564042
Study groupRoleWhat they receive
GSK2894512 1% cream twice dailyExperimentalSubjects will apply a thin layer of GSK2894512 1% (10 milligram per gram [mg/g]) topical cream twice daily (morning and evening) for 12 weeks, to all psoriasis lesions (except on the scalp).
Receives: Drug: GSK2894512 1% Cream
GSK2894512 1% cream once dailyExperimentalSubjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all psoriasis lesions (except on the scalp).
Receives: Drug: GSK2894512 1% Cream
GSK2894512 0.5% cream twice dailyExperimentalSubjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all psoriasis lesions (except on the scalp).
Receives: Drug: GSK2894512 0.5% Cream
GSK2894512 0.5% cream once dailyExperimentalSubjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all psoriasis lesions (except on the scalp).
Receives: Drug: GSK2894512 0.5% Cream
Vehicle cream twice dailyPlacebo comparatorSubjects will apply a thin layer of vehicle topical cream twice daily (morning and evening) for 12 weeks, to all psoriasis lesions (except on the scalp).
Receives: Drug: Vehicle cream
Vehicle cream once dailyPlacebo comparatorSubjects will apply a thin layer of vehicle topical cream once daily (evening) for 12 weeks, to all psoriasis lesions (except on the scalp).
Receives: Drug: Vehicle cream

What is being measured

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

  1. Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12

    The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008.

    Measured: Baseline and up to Week 12

Secondary outcomes (33)

  1. Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit

    The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with >=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  2. Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit

    The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  3. Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit

    The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 16

  4. Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit

    The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  5. Mean Change in PASI Score From Baseline to Each Study Visit

    The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  6. PGA Scores at Each Study Visit

    The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 16

  7. Mean Change in PGA Score From Baseline to Each Study Visit

    The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  8. Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit

    A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  9. Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit

    The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  10. Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit

    The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 16

  11. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

    An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.

    Measured: Up to Week 16

  12. Number of Participants With Reported Local Tolerability Scores

    The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 14

  13. Change From Baseline in Albumin and Protein Level

    Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  14. Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.

    Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  15. Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.

    Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  16. Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels

    Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  17. Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count

    Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  18. Change From Baseline in Hematocrit Levels

    Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  19. Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)

    Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  20. Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level

    Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  21. Change From Baseline in Erythrocyte Mean Corpuscular Volume

    Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  22. Change From Baseline in Erythrocyte Count

    Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  23. Number of Participants With Chemistry Data of Potential Clinical Importance

    Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 14

  24. Number of Participants With Hematology Data of Clinical Importance

    Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 14

  25. Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels

    Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 12

  26. Number of Participants With Ig Data Outside the Reference Range

    Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 12

  27. Number of Participants With Immunophenotyping Data Outside the Reference Range

    Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 12

  28. Change From Baseline in Immunophenotype Data

    Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 12

  29. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  30. Change From Baseline in Pulse Rate

    Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  31. Change From Baseline in Temperature

    Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Baseline and up to Week 14

  32. Number of Participants With Vital Signs of Clinical Importance

    The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 14

  33. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or "Any time post-screen", a participant is categorized as "Abnormal" if >=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).

    Measured: Up to Week 14

Timeline

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

  1. First posted30 Sep 2015 (estimated)
  2. Study start23 Nov 2015
  3. Primary completion1 Oct 2016
  4. Study completion5 Oct 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02564042
Sponsor's protocol ID
203120
Status last verified
Oct 2017
First submitted
28 Sep 2015
Last updated
13 Nov 2017
Data monitoring committee
Yes

Publications

  • Grossmann MC, Pixley JN, Feldman SR. A Review of Topical Tapinarof for the Treatment of Plaque Psoriasis. Ann Pharmacother. 2024 Jan;58(1):76-85. doi: 10.1177/10600280231164775. Epub 2023 Apr 19.

    PubMed 37076998

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK2894512 1% Cream and GSK2894512 0.5% Cream in people with Psoriasis, run by GlaxoSmithKline at 46 sites in 3 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 6 inclusion and 12 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Japan, Canada. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Nov 2017). 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?

Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 (time frame: Baseline and up to Week 12). 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 NCT02564042, 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 13 Nov 2017.

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