For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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
  2. 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.
  3. 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 CRITERIA

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria apply

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Systemic Lupus Erythematosus

Age (in years)

18 - 70

Phase

Phase 2

Participants needed

268

Est. Completion Date

May 15, 2026

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT04895696

Study number

IM026024

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