At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Stable plaque psoriasis diagnosed ≥6 months
- ✓BSA involvement 5–15% excluding face and intertriginous areas (up to 2% on scalp permitted)
- ✓PGA score ≥2 at Baseline
- ✕Psoriasis variant other than plaque (guttate, punctate, erythroderma, pustular)
- ✕Current or history of acute/chronic cutaneous infection or significant skin infections
- ✕Clinically relevant skin disease or pathologies interfering with skin evaluations
- ✕Malignancy within 5 years except adequately treated non-invasive skin cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-part Trial to Evaluate the Safety, Tolerability, Clinical Effect and Systemic Exposure Potential of Topically Applied GSK2981278 Ointment in Subjects With Plaque Psoriasis
In Brief
A Phase 2 clinical trial evaluating GSK2981278 ointment and Vehicle ointment for Psoriasis. Completed, enrolled 8 participants across 1 site.
Detailed Summary
GSK2981278 is an inverse agonist of retinoic acid receptor-related orphan receptor (ROR) gamma. The aim of this study is to evaluate the safety, tolerability, clinical effect, and systemic exposure potential of topically applied GSK2981278 ointment in subjects with plaque psoriasis by treating all plaques on the body for 8 weeks. This single-center study will be conducted in two parts. Part A will be an open-label, single arm study and part B will be a double-blind, randomized, 2-arm, parallel-group, vehicle-controlled study. In Part A, 8 adult subjects and in Part B, 18 adult subjects with chronic stable plaque psoriasis will be enrolled. Total duration of study will be approximately 14 weeks. The results of this study will provide preliminary information about safety and efficacy of the drug and will help in providing the guidance for further development strategy.
Study Details
Timeline
Interventions
GSK2981278 ointment will be applied topically twice daily for 8 weeks to all subjects in Part A and to randomized subjects in Part B. GSK2981278 will be a white to off-white ointment and a thin layer will be applied to all affected areas for given timeframe. GSK2981278 is available as white to off-white ointment in unit strength 4% (w/w), 2% (w/w) and 0.8% (w/w), for topical application for application as thin layer to all affected areas .
It will be supplied as white to off-white vehicle ointment for topical application.