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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Birmingham

Local Institution - 0100, Birmingham, Alabama, United States, 35205

Fullerton

St Joseph Heritage Healthcare-Rheumatology, Fullerton, California, United States, 92835

Huntington Beach

Christine Thai, MD, Huntington Beach, California, United States, 92648

La Jolla

UCSD - Altman Clinical and Translational Research Institute (ACTRI), La Jolla, California, United States, 92037

La Palma

Advanced Medical Research - La Palma, La Palma, California, United States, 90623

Los Angeles

Local Institution - 0202, Los Angeles, California, United States, 90095

San Diego

Rheumatology Center of San Diego, San Diego, California, United States, 92128

West Hills

Private Practice - Dr. Nazanin Firooz, West Hills, California, United States, 91307

Woodland Hills

Local Institution - 0164, Woodland Hills, California, United States, 91364

Denver

Colorado Arthritis Associates, Denver, Colorado, United States, 80204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2029-04-22