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.

Timeline

Start

2015-10-22

Primary completion

2016-02-19

Completion

2016-02-19

Publications

• Kang EG, Wu S, Gupta A, von Mackensen YL, Siemetzki H, Freudenberg JM, Wigger-Alberti W, Yamaguchi Y. A phase I randomized controlled trial to evaluate safety and clinical effect of topically applied GSK2981278 ointment in a psoriasis plaque test. Br J Dermatol. 2018 Jun;178(6):1427-1429. doi: 10.1111/bjd.16131. Epub 2018 Mar 23. No abstract available.

Drugs

Indications