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

NCT04895696 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 268

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DRUG

Afimetoran

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2026-06-18
Completion
2029-04-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • China
  • Colombia
  • France
  • Germany
  • India
  • Ireland
  • Japan
  • Mexico
  • Poland
  • Puerto Rico
  • Romania
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04895696 on ClinicalTrials.gov