IM026-024: Phase 2, BMS-986256 Compared with Placebo in Participants with Active SLE
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of BMS-986256 in Participants with Active Systemic Lupus Erythematosus.
IRAS ID
1004059
Contact name
Head of the Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-004021-25
Clinicaltrials.gov Identifier
Research summary
This is a phase 2 trial in patients with active systemic lupus erythematosus (SLE). The study will use 1 drug called BMS-986256 and will investigate if it is an effective treatment for 18+ year old SLE patients and assess safety. BMS-986256 is designed to reduce the over activity of the immune system seen in SLE by inhibiting a pathway which is part of the body’s immune response, a Toll-like receptor. 344 patients will take part globally in this study, 10 of them in the UK.
The study is double-blind, so patients and doctors will not know what treatment patients are on, except in an emergency. Following a screening period, eligible patients will be randomly assigned to receive either 2.5mg, 10mg, or 30mg of BMS-986256, or placebo once daily. The placebo is a dummy treatment, one that looks like BMS-986256 but contains no active study drug. There is a 75% chance that patients will receive BMS-986256 and a 25% chance that they will receive the placebo.
Patients will have up to 14 treatment visits over 48 weeks unless: their disease progresses, they experience unacceptable side effects, they choose to withdraw, or the study is stopped.
During the study, patients will have the following procedures: physical exams, SLE disease assessments, photography of affected skin areas, ECG (measurement of the heart’s performance), vital signs (blood pressure, heart rate and temperature), blood sampling and pregnancy testing (if applicable). They may need a chest X-ray at screening and will have to complete questionnaires regularly.
Patients will attend 1 follow-up visit at the trial centre on week 52.
The study is funded by Bristol Myers Squibb.REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0821
Date of REC Opinion
14 Jan 2022
REC opinion
Further Information Favourable Opinion