A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Other: Placebo
- Registration Number
- NCT04895696
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 268
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afimetoran: Dose 1 Afimetoran - Placebo Placebo - Afimetoran: Dose 2 Afimetoran - Afimetoran: Dose 3 Afimetoran -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of participants with clinical laboratory abnormalities Up to 100 Weeks Number of participants with vital sign abnormalities Up to 100 Weeks Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response 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 Change from baseline in PGA score of disease activity at Week 24 and Week 48 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)
Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48 Up to 48 Weeks Number of participants with Adverse Events (AEs) Up to 100 Weeks Number of participants with physical examination abnormalities Up to 100 Weeks Number of participants with electrocardiogram (ECG) abnormalities Up to 52 Weeks Proportion of participants who achieve an SRI(4) response at Week 24 Up to 24 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 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 in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36) 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.
Number of participants with Serious Adverse Events (SAEs) Up to 100 Weeks 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
Trial Locations
- Locations (147)
Local Institution - 0100
🇺🇸Birmingham, Alabama, United States
Local Institution - 0123
🇺🇸Huntington Beach, California, United States
Local Institution - 0170
🇺🇸La Jolla, California, United States
Local Institution - 0159
🇺🇸La Palma, California, United States
Local Institution - 0172
🇺🇸San Diego, California, United States
Local Institution - 0164
🇺🇸Woodland Hills, California, United States
Local Institution - 0121
🇺🇸Clearwater, Florida, United States
Local Institution - 0167
🇺🇸Kissimmee, Florida, United States
Local Institution - 0122
🇺🇸Orlando, Florida, United States
Local Institution - 0173
🇺🇸Ormond Beach, Florida, United States
Scroll for more (137 remaining)Local Institution - 0100🇺🇸Birmingham, Alabama, United States