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NCT Number: NCT04895696

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0130, Quilmes, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afimetoran

Drug

Specified dose on specified days

Other names: BMS-986256

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48

    Time frame: Up to 48 Weeks

Secondary outcomes

  1. Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48

    Time frame: Up to 48 Weeks

  2. Proportion of participants who achieve an SRI(4) response at Week 24

    Time frame: Up to 24 Weeks

  3. Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48

    Time frame: Up to 48 Weeks

  4. Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48

    Time frame: Up to 48 Weeks

  5. Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48

    Time frame: Up to 48 Weeks

  6. Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline

    Time frame: Up to 48 Weeks

  7. Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline

    Time frame: Up to 48 Weeks

  8. Change from baseline in PGA score of disease activity at Week 24 and Week 48

    Time frame: Up to 48 Weeks

    PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)

  9. Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48

    Time frame: Up to 48 Weeks

  10. Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)

    Time frame: Up to 48 Weeks

    The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.

  11. Number of participants with Adverse Events (AEs)

    Time frame: Up to 100 Weeks

  12. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to 100 Weeks

  13. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 100 Weeks

  14. Number of participants with physical examination abnormalities

    Time frame: Up to 100 Weeks

  15. Number of participants with vital sign abnormalities

    Time frame: Up to 100 Weeks

  16. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 52 Weeks

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
May 20, 2021
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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