Ph3b/4 study of Deucravacitinib for Moderate-To-Severe Scalp Psoriasis (Psoriatyk Scalp)
Research type
Research Study
Full title
A PHASE 3B/4, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DEUCRAVACITINIB IN PARTICIPANTS WITH MODERATE-TO-SEVERE SCALP PSORIASIS (PSORIATYK SCALP)
IRAS ID
1004460
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2022-000797-26
Clinicaltrials.gov Identifier
Research summary
Psoriasis is a chronic inflammatory skin disorder, characterised primarily by scaly plaques, that affects up to 3% (3 in 100) of the general population. Up to 80% (8 in 10) of people living with psoriasis may have scalp psoriasis. The purpose of this study is to measure how safe and effective the investigational drug BMS-986165 (also known as deucravacitinib) is in treating participants with scalp psoriasis. Other research studies in animals and humans showed that deucravacitinib may help control the immune system that is responsible for the signs and symptoms of psoriasis by controlling the molecules in the body responsible for inflammation within the skin.
About 220 participants will be enrolled in the study with approximately 150 people (men and women aged 18 years or older) who have moderate to severe scalp psoriasis participating in the treatment phase. Participation duration is 60 weeks as follows:
• screening (up to 4 weeks)
• treatment (52 weeks)
• follow-up (4 weeks)
This will involve approximately 15 visits to the study doctor. Participants will be randomised (like a flip of a coin) to the active drug deucravacitinib or placebo. Starting at week 16, all participants will receive deucravacitinib for the remainder of the treatment period.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0245
Date of REC Opinion
9 Jan 2023
REC opinion
Further Information Favourable Opinion