NCT04895696

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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Afimetoran	Specified dose on specified days
OTHER	Placebo	Specified dose on specified days

Timeline

• Start date: 2021-10-11
• Primary completion: 2026-03-29
• Completion: 2029-04-22
• First posted: 2021-05-20
• Last updated: 2025-06-10

Locations

147 sites across 19 countries: United States, Argentina, Australia, Brazil, Chile, China, Colombia, France, Germany, India, Ireland, Japan, Mexico, Poland, Puerto Rico, Romania, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study