A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With ActiveSystemic 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-IE
• 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: 2021-10-08
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

- Diagnosed = 12 weeks before the screening visit and qualify as having Systemic Lupus Erythematosus (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

Inclusion criteria for long-term extension (LTE) period:
- Completion of study treatment through Week 48
- In the opinion of the investigator, participant may benefit from continuation in the optional LTE period

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 532
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

Exclusion criteria for long-term extension (LTE) period:
- Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, psychiatric) or active infection/infectious illness that, as determined by the investigator's clinical judgment, will substantially increase the risk to the participant if he or she participates in the LTE.

Other protocol-defined exclusion criteria apply.

Study & Design

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