Systemic Lupus Erythematosus
Conditions
Keywords
BMS-986256, Systemic Lupus Erythematosus, SLE, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases, Afimetoran
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.
Interventions
DRUGAfimetoran
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Beeline Medicines Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | — |
| 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 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 | — |
Countries
Argentina, Australia, Brazil, Chile, China, Colombia, France, Germany, India, Ireland, Japan, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORBeeline Medicines Corporation
Beeline Medicines Corporation
Outcome results
None listed