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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT04895696

Run by

Bristol-Myers Squibb

People needed

248

Starts

2021-10-11

Expected to finish

2029-04-22

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Local Institution - 0123 — Huntington Beach, California, United States
• Local Institution - 0170 — La Jolla, California, United States
• Local Institution - 0159 — La Palma, California, United States
• Local Institution - 0172 — San Diego, California, United States
• Local Institution - 0164 — Woodland Hills, California, United States
• Local Institution - 0121 — Clearwater, Florida, United States
• Local Institution - 0167 — Kissimmee, Florida, United States
• Local Institution - 0122 — Orlando, Florida, United States
• Local Institution - 0173 — Ormond Beach, Florida, United States
• Local Institution - 0154 — Plantation, Florida, United States
• Local Institution - 0137 — South Miami, Florida, United States
• Local Institution - 0155 — Tamarac, Florida, United States
• Local Institution - 0160 — Atlanta, Georgia, United States
• Local Institution - 0205 — Suwanee, Georgia, United States
• Local Institution - 0146 — Orland Park, Illinois, United States
• Local Institution - 0187 — Hopkinsville, Kentucky, United States
• Local Institution - 0171 — Baton Rouge, Louisiana, United States
• Local Institution - 0134 — Wheaton, Maryland, United States
• Local Institution - 0070 — Eagan, Minnesota, United States
• Local Institution - 0124 — St Louis, Missouri, United States
• Local Institution - 0165 — St Louis, Missouri, United States
• Local Institution - 0091 — Las Vegas, Nevada, United States
• Local Institution - 0219 — West Long Branch, New Jersey, United States
• Local Institution - 0140 — Manhasset, New York, United States
• Local Institution - 0100 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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