Study of Safety and Efficacy of Topical GSK2981278 Ointment in Plaque Psoriasis

Summary

GSK2981278 is a highly potent and selective inverse agonist of retinoic acid receptor-related orphan receptor gamma (ROR gamma) that is under development for topical treatment of plaque type psoriasis suitable for topical therapy.

This is the first study to administer GSK2981278 to subjects with psoriasis. This proof-of-concept study will evaluate the safety, tolerability and initial efficacy of a range of concentrations of GSK2981278 ointment with repeated topical applications in adult subjects with psoriasis. Results of this study will provide first clinical information on the drug's safety and efficacy in psoriasis and inform the selection of concentration of GSK2981278 ointment to be evaluated in subsequent clinical studies.

This is a Phase 1, single center, test field-randomized, vehicle- and positive- controlled, subject- and evaluator-blind study. All subjects will receive all 6 treatments on 6 test fields, for intra-individual treatment comparison. For every subject, the manner of assignment of each treatment to a particular test field will be according to a randomization scheme. Thus, the test fields within each subject, and not the subjects themselves, will be randomized.

The study will consist of screening, followed by a treatment period of 19 days, and a follow-up visit at Day 27 (+/-2) for subjects who will consent for biopsy. During the treatment period, subjects will receive all of these treatments: GSK2981278 ointment 0.03% weight by weight \[w/w\], 0.1% w/w, 0.8% w/w, 4% w/w, GSK2981278 vehicle, and betamethasone valerate 0.1% cream. The test fields on which these treatments will be applied will be identified on stable plaque(s) on the upper extremities, thighs and/or trunk. A blinded evaluator (an investigator or designee) will perform the measurements and assessments whereas an unblinded study staff member (not an evaluator) will perform biopsy collection.

Conditions

• Psoriasis

Interventions

DRUG

GSK2981278 0.03%

GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.03%. Approximately 200 microliters of the GSK2981278 0.03% ointment will be applied topically to the assigned test field once daily.

DRUG

GSK2981278 0.1%

GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.1%. Approximately 200 microliters of the GSK2981278 0.1% ointment will be applied topically to the assigned test field once daily.

DRUG

GSK2981278 0.8%

GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.8%. Approximately 200 microliters of the GSK2981278 0.8% ointment will be applied topically to the assigned test field once daily.

DRUG

GSK2981278 4%

GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 4%. Approximately 200 microliters of the 4% ointment will be applied topically to the assigned test field once daily.

DRUG

Vehicle

GSK2981278 vehicle will be supplied as a white to off-white ointment containing no drug substance. Approximately 200 microliters of the vehicle will be applied topically to the assigned test field once daily.

DRUG

Betamethasone valerate 0.1%

Betamethasone valerate will be supplied as a cream. Approximately 200 microliters of the 0.1% betamethasone valerate cream will be applied topically to the assigned test field once daily.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-22

Primary Completion

2016-02-19

Completion

2016-02-19

Countries

• Germany

Study Locations