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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

Active Not RecruitingPhase 2

Sponsor: Beeline Medicines Corporation

Conditions: Systemic Lupus Erythematosus

Interventions: Afimetoran, Placebo

Countries: United States, Argentina, Australia, Brazil, Chile, China, Colombia, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (147)

Birmingham, Alabama, United States
Huntington Beach, California, United States
La Jolla, California, United States
La Palma, California, United States
San Diego, California, United States
Woodland Hills, California, United States
Clearwater, Florida, United States
Kissimmee, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Plantation, Florida, United States
South Miami, Florida, United States
Tamarac, Florida, United States
Atlanta, Georgia, United States
Suwanee, Georgia, United States
Orland Park, Illinois, United States
Hopkinsville, Kentucky, United States
Baton Rouge, Louisiana, United States
Wheaton, Maryland, United States
Eagan, Minnesota, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
West Long Branch, New Jersey, United States
Manhasset, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Middleburg Heights, Ohio, United States
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