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Clinical Trials in the UK / NCT04895696
Active, not recruiting Phase 2

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

NCT04895696 · tracked via the Priya Life Science UK tracker
Sponsor
Beeline Medicines Corporation
Phase
Phase 2
Started
2021-10-11
Last updated
2026-08-17

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

AfimetoranPlacebo

Afimetoran: Specified dose on specified days

Placebo: Specified dose on specified days

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (147)

FacilityCityRegionStatus
Local Institution - 0100 Birmingham Alabama
Local Institution - 0123 Huntington Beach California
Local Institution - 0170 La Jolla California
Local Institution - 0159 La Palma California
Local Institution - 0172 San Diego California
Local Institution - 0164 Woodland Hills California
Local Institution - 0121 Clearwater Florida
Local Institution - 0167 Kissimmee Florida
Local Institution - 0122 Orlando Florida
Local Institution - 0173 Ormond Beach Florida
Local Institution - 0154 Plantation Florida
Local Institution - 0137 South Miami Florida
Local Institution - 0155 Tamarac Florida
Local Institution - 0160 Atlanta Georgia
Local Institution - 0205 Suwanee Georgia
Local Institution - 0146 Orland Park Illinois
Local Institution - 0187 Hopkinsville Kentucky
Local Institution - 0171 Baton Rouge Louisiana
Local Institution - 0134 Wheaton Maryland
Local Institution - 0070 Eagan Minnesota
Local Institution - 0124 St Louis Missouri
Local Institution - 0165 St Louis Missouri
Local Institution - 0091 Las Vegas Nevada
Local Institution - 0219 West Long Branch New Jersey
Local Institution - 0140 Manhasset New York
Local Institution - 0132 The Bronx New York
Local Institution - 0203 Charlotte North Carolina
Local Institution - 0103 Charlotte North Carolina
Local Institution - 0151 Columbus Ohio
Local Institution - 0042 Middleburg Heights Ohio
Local Institution - 0152 Allen Texas
Local Institution - 0197 Allen Texas
Local Institution - 0136 Amarillo Texas
Local Institution - 0029 Mesquite Texas
Local Institution - 0163 San Antonio Texas
Local Institution - 0223 Bellevue Washington
Local Institution - 0207 Buenos Aires Buenos Aires
Local Institution - 0128 Buenos Aires Buenos Aires
Local Institution - 0130 Quilmes Buenos Aires
Local Institution - 0195 San Fernando Buenos Aires

+ 107 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04895696 on ClinicalTrials.gov ↗ ← All trials in the UK