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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: Afimetoran
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afimetoran: Dose 1<br> | Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|
| Experimental: Afimetoran: Dose 2<br> | Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|
| Experimental: Afimetoran: Dose 3<br> | Drug: Afimetoran<br>* Specified dose on specified days<br>* Other names: BMS-986256;|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48 |  | Up to 48 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48 |  | Up to 48 Weeks | 
| Proportion of participants who achieve an SRI(4) response at Week 24 |  | Up to 24 Weeks | 
| Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48 |  | Up to 48 Weeks | 
| 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 |  | Up to 48 Weeks | 
| 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 |  | Up to 48 Weeks | 
| 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 |  | Up to 48 Weeks | 
| 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 |  | Up to 48 Weeks | 
| Change from baseline in PGA score of disease activity at Week 24 and Week 48 | PGA = Physician Global Assessment of disease activity (score of 0 indicating no disease activity and higher scores indicating higher disease activity) | Up to 48 Weeks | 
| Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48 |  | Up to 48 Weeks | 
| 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) | 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. | Up to 48 Weeks | 
| Number of participants with Adverse Events (AEs) |  | Up to 100 Weeks | 
| Number of participants with Serious Adverse Events (SAEs) |  | Up to 100 Weeks | 
| Number of participants with clinical laboratory abnormalities |  | Up to 100 Weeks | 
| Number of participants with physical examination abnormalities |  | Up to 100 Weeks | 
| Number of participants with vital sign abnormalities |  | Up to 100 Weeks | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 52 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986256, Systemic Lupus Erythematosus, SLE, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases, Afimetoran