A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

a study on Lupus

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

Official Title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus, BMS-986256, SLE, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases, Afimetoran

Eligibility

You can join if…

Open to people ages 18-70

  • Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
  • Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
  • Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

You CAN'T join if...

  • Active severe lupus nephritis (LN) as assessed by the investigator
  • Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
  • Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
  • Antiphospholipid Syndrome

Other protocol-defined inclusion/exclusion criteria apply

Locations

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) accepting new patients
    La Jolla California 92037 United States
  • Local Institution - 0202 not yet accepting patients
    Los Angeles California 90095 United States
  • Christine Thai, MD accepting new patients
    Huntington Beach California 92648 United States
  • Local Institution - 0164 completed
    Woodland Hills California 91364 United States
  • Rheumatology Center of San Diego accepting new patients
    San Diego California 92128 United States
  • Private Practice - Dr. Nazanin Firooz withdrawn
    West Hills California 91307 United States
  • St Joseph Heritage Healthcare-Rheumatology withdrawn
    Fullerton California 92835 United States
  • Advanced Medical Research - La Palma accepting new patients
    La Palma California 90623 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04895696
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 268 study participants
Last Updated