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Evaluating Afimetoran for treating active Systemic Lupus Erythematosus

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

Phase 2 Interventional Bristol-Myers Squibb · NCT04895696

This study is testing if a new medication called Afimetoran can help people with active Systemic Lupus Erythematosus feel better and improve their health.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment268 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations174 sites (Birmingham, Alabama and 173 other locations)
Trial IDNCT04895696 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of Afimetoran in patients diagnosed with active Systemic Lupus Erythematosus (SLE). Participants will be randomized to receive either Afimetoran or a placebo, with an extension period allowing those on placebo to switch to treatment. The study will monitor the participants for improvements in disease activity and overall health. The evaluation will include long-term safety and efficacy data.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with SLE for at least 12 weeks and exhibiting specific autoantibodies and disease activity scores.

Not a fit: Patients with active severe lupus nephritis or unstable neuropsychiatric manifestations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from active Systemic Lupus Erythematosus.

How similar studies have performed: Other studies have shown promise in targeting similar pathways in autoimmune diseases, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 173 other locations

+124 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusBMS-986256SLEConnective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAfimetoran
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.