NCT04316585

A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants

A Multicentre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK2982772 in Participants With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Plaque psoriasis is a chronic relapsing inflammatory skin disease that is characterized by keratinocyte hyper-proliferation and epidermal hyperplasia. Standard treatment for psoriasis generally requires long-term use of topical therapies, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB) and/or systemic immunosuppressant therapies to achieve and maintain adequate disease control. This is a multicenter, randomized, double-blind study conducted in participants with moderate to severe plaque psoriasis. The study will evaluate the efficacy, safety, pharmacokinetic and pharmacodynamics profile of 960 milligram (mg) GSK2982772 administered as a once daily modified release (MR) formulation. Participants will be randomized in a 2:1 ratio to receive either 960 mg GSK2982772 or placebo for 12 weeks. The duration of the study, including Screening and follow-up, will be approximately 21 weeks for each participant.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	GSK2982772	GSK2982772 will be available as MR tablet at a unit dose strength of 480 mg.
DRUG	Placebo	GSK2982772 matching placebo tablets will be administered via the oral route.

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-09-13
• Completion: 2021-10-12
• First posted: 2020-03-20
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

9 sites across 2 countries: Canada, Poland