Status:
ACTIVE_NOT_RECRUITING
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 addi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 22 2029
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04895696
Start Date
October 11 2021
End Date
April 22 2029
Last Update
June 10 2025
Active Locations (147)
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1
Local Institution - 0100
Birmingham, Alabama, United States, 35205
2
Local Institution - 0123
Huntington Beach, California, United States, 92648
3
Local Institution - 0170
La Jolla, California, United States, 92037
4
Local Institution - 0159
La Palma, California, United States, 90623