The trial is taking place at:
M

Millennium Research | Ormond Beach, FL

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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Afimetoran
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04895696
2023-504320-25-00 (Registry Identifier)
U1111-1241-6528 (Registry Identifier)
IM026-024

Details and patient eligibility

About

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.

Enrollment

268 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

268 participants in 4 patient groups, including a placebo group

Afimetoran: Dose 1
Experimental group
Treatment:
Drug: Afimetoran
Afimetoran: Dose 2
Experimental group
Treatment:
Drug: Afimetoran
Afimetoran: Dose 3
Experimental group
Treatment:
Drug: Afimetoran
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

170

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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