Efficacy and Safety of Afimetoran Compared with Placebo in Participants with Active Systemic Lupus Erythematosus

Phase 1

Recruiting

Conditions: Active Systemic Lupus Erythematosus
MedDRA version: 21.1Level: PTClassification code: 10042945Term: Systemic lupus erythematosus Class: 100000004859
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-504320-25-00

Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

Diagnosed = 12 weeks before the screening visit and qualify as having Systemic Lupus Erythematosus (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, Inclusion criteria for long-term extension (LTE) period: - Completion of study treatment through Week 48 - In the opinion of the investigator, participant may benefit from continuation in the optional LTE period

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, Exclusion criteria for long-term extension (LTE) period: - Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric) or active infection/infectious illness that, as determined by the investigator's clinical judgment, will substantially increase the risk to the participant if he or she participates in the LTE