GSK2894512 Vehicle-Controlled Study for Adult Plaque Psoriasis

NCT03202004 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 200852
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy and safety of GSK2894512 cream for the topical treatment of plaque psoriasis (psoriasis) with its vehicle cream. This is a randomized, double-blind, vehicle-controlled, parallel-group, multicenter study in adults with psoriasis. The aim of this study is to show superiority of GSK2894512 over vehicle by comparing their response rates. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks blinded treatment, and 1 week post-treatment follow-up period. Subjects will apply randomized study treatment to all psoriasis lesions once daily for 12 weeks. Subjects will be stratified by Baseline physician global assessment (PGA) category (PGA score=2, PGA score \>=3) at randomization. Approximately 120 subjects will be randomized into the study of which 80 will receive GSK2894512 1% cream and 40 will receive vehicle cream. Total duration of a subject's participation in the study will be approximately for 14 to 17 weeks.

Conditions

Psoriasis

Keywords

PGA; efficacy; PASI; GSK2894512; NRS; Topical; psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion OF SUBJECTS WITH PGA SCORE OF CLEAR OR ALMOST CLEAR (0 OR 1) AND A MINIMUM 2-GRADE IMPROVEMENT IN PGA SCORE FROM BASELINE AND WEEK 12

  PGA is a clinical tool (a 5 point scale) for assessing the current state/severity of a subject's psoriasis. It is a morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Subjects will be scored using the following categories: 0=Clear; 1=Almost clear; 2=Mild; 3=Moderate; and 4=Severe.

  Baseline (Day 1) and Week 12

Secondary Outcomes (2)

• Proportion of subjects with >=75% improvement in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12

  Baseline (Day 1) and up to Week 12

• Proportion OF SUBJECTS WITH>=3-POINT REDUCTION IN WEEKLY AVERAGE ITCH/PRURITUS NUMERIC RATING SCALE (NRS) FROM BASELINE TO WEEK 12 FOR SUBJECTS WITH A BASELINE SCORE >=4

  Baseline (Day 1) and up to Week 12

Study Arms (2)

GSK2894512 1% cream group

EXPERIMENTAL

Subjects will apply a thin layer of GSK2894512 1% (10 milligrams per gram \[mg/g\]) topical cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.

Drug: GSK2894512 1% cream

Vehicle cream group

PLACEBO COMPARATOR

Subjects will apply a thin layer of vehicle cream once daily to all psoriasis lesions for 12 weeks. The study staff will instruct subjects on proper topical application of cream.

Drug: Vehicle cream

Interventions

GSK2894512 1% cream DRUG

1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.

GSK2894512 1% cream group

Vehicle cream DRUG

Vehicle cream will be provided in tubes labeled in compliance with country requirements.

Vehicle cream group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years at the time of signing the informed consent.
• Clinical diagnosis of chronic stable plaque psoriasis. Diagnosis and chronicity to be confirmed and documented by an experienced dermatologist.
• Body surface area involvement \>=2%.
• A PGA score of \>=2.
• One target plaque located on the trunk or extremities that is at least 9 centimeter (cm)\^2 in size with a target plaque severity score (TPSS) \>=5 and an induration sub score \>=2. Primary target plaque should not be located on the knees, elbows, feet, ankle, hands, intertriginous areas, face, or scalp.)
• Male or female. A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP), OR
• Is a WOCBP who agrees to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 1 week after the last exposure to study treatment.
• Capable of giving signed informed consent

You may not qualify if:

• Psoriasis other than plaque variant.
• Any sign of infection of any of the psoriatic lesions.
• Concurrent conditions and history of other diseases:
• Immunocompromised (examples: lymphoma, acquired immunodeficiency syndrome) or have a history of malignant disease within 5 years before the Baseline visit.
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the Baseline visit.
• Active acute bacterial, fungal, or viral (examples: herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the Baseline visit
• Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study.
• 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 GSK2894512 or excipients of the study treatments, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation.
• Alanine transferase (ALT) \>2 times upper limit of normal (ULN).
• Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
• Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B or C, examples: presence of hepatitis B surface antigen \[HBsAg\] or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment) is acceptable if the subject otherwise meets entry criteria.
• QT interval corrected for heart rate according to Fridericia's formula QTcF \>450 milliseconds (msec) or QTcF \>480 msec in subjects with bundle branch block.
• Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (examples: phototherapy, tanning beds/booths, or therapeutic sunbathing) within 4 weeks prior to the Baseline visit and/or intention to have such exposure during the study, which could potentially impact the subject's psoriasis (as determined by the investigator).

Sponsors & Collaborators

• GlaxoSmithKline: lead
• PPD Development, LP: collaborator
• ERT: Clinical Trial Technology Solutions: collaborator
• Q2 Solutions: collaborator

MeSH Terms

Conditions

Psoriasis

Interventions

tapinarof

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator, study center staff, subject, and sponsor will be blinded to randomized study treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: January 22, 2018
• Primary Completion: September 28, 2018
• Study Completion: September 28, 2018
• Last Updated: December 7, 2017

Record last verified: 2017-12