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NCT04895696 · ClinicalTrials.gov record · last posted 2026-08-17

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

StatusActive, Not Recruiting
PhasePhase 2
Started2021-10-11
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from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-08-18
Sponsor changed: Bristol-Myers Squibb → Beeline Medicines Corporation
WasBristol-Myers Squibb
NowBeeline Medicines Corporation
Trial Details
NCT Number NCT04895696
Lead Sponsor Beeline Medicines Corporation
Conditions Systemic Lupus Erythematosus
Enrollment 248 participants
Start Date 2021-10-11
Primary Completion 2026-06-12 (estimated)
Study Completion 2029-04-22 (estimated)
Updated on ClinicalTrials.gov 2026-08-17