IM032041 - BMS-986322 in Participants with Moderate to Severe Psoriasis
Research type
Research Study
Full title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants with Moderate-to-Severe Psoriasis
IRAS ID
1007273
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Clinicaltrials.gov Identifier
Research summary
The primary objective of this study is to evaluate the response rate in Psoriasis Area and Severity Index Score (PASI-75) after 12 weeks of treatment with BMS-986322. The response rate in PASI-75 is defined as the proportion of participants with moderate-to-severe PsO experiencing a 75% improvement (reduction from baseline) in PASI score at Week 12 (Day 85).
The purpose of this study is to learn about the effects and safety of the research medicine, BMS-986322, in participant with moderate to severe psoriasis. Inflammation of the skin is one of the common symptoms of psoriasis. Several proteins have been shown to be involved in psoriasis and several other inflammatory diseases.
Researchers have found that BMS-986322 can "inhibit", block or stop one of these proteins from working. This study will investigate if BMS 986322 can reduce the symptoms of psoriasis by inhibiting the function of this protein.
Three different doses of BMS-986322 will be compared to placebo during 12 weeks of treatment, to find out which is better for treating psoriasis. A placebo looks like the research medicine but does not contain any active medicine. The study will also assess and compare the safety and tolerability of the three different doses of BMS-986322, measure the amount of BMS-986322 in the blood at various time points and investigate whether BMS-986322 has any effect on the quality of life of participants with moderate to severe psoriasis.
Approximately 120 participants will be randomised and treated globally with XX of these participants being in the UK.
The total duration of the study will be a maximum of 20 weeks for each study participant, with the study intervention period being 12 weeks long.
Participants will visit the study hospital / clinic on:
1. Day 1 – Day -28 to -1
2. Week 1 – Day 8
3. Week 2 – Day 15
4. Week 4 – Day 29
5. Week 8 – Day 57
6. Week 12 – Day 85 / if applicable, Early Termination.
7. Week 16 – Day 115REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0194
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion