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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Placebo; Drug: Afimetoran

Study type: Interventional

Funder types: Industry

Identifiers

NCT04895696

2023-504320-25-00 (Registry Identifier)

U1111-1241-6528 (Registry Identifier)

IM026-024

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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268 participants in 4 patient groups, including a placebo group

Afimetoran: Dose 1

Experimental group

Treatment:

Drug: Afimetoran

Afimetoran: Dose 2

Experimental group

Treatment:

Drug: Afimetoran

Afimetoran: Dose 3

Experimental group

Treatment:

Drug: Afimetoran

Placebo

Placebo Comparator group

Treatment:

Other: Placebo