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  • NCT04895696

Recruiting

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) - IM026-024

Updated: 20 November, 2024   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18-70

    Age Range

  • 49

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Afimetoran: Dose 1
Drug: Afimetoran
Experimental: Afimetoran: Dose 2
Drug: Afimetoran
Experimental: Afimetoran: Dose 3
Drug: Afimetoran
Placebo Comparator: Placebo
Other: Placebo

Key Eligibility Criteria

Inclusion Criteria: - 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 Criteria: - 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

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Side effects and other reportable events are defined here
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466-DK-2200001