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

Phase 1

• Conditions: Active Systemic Lupus Erythematosus.; MedDRA version: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-004021-25-PL
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-24
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

- Qualify as having Systemic Lupus Erythematosus (SLE), according to the SLE International Collaborating Clinics (SLICC) Classification Criteria = 12 weeks before 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

Other protocol-defined inclusion criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 582
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

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 exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified