Last updated 9 days ago
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
268 patients around the world
Available in Argentina, Puerto Rico, Colombia, Brazil
Bristol-Myers Squibb
16Research sites
268Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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 visitTest 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
- Active severe lupus nephritis (LN) as assessed by the investigatorActive or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAIDiagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLEAntiphospholipid Syndrome
Sites
CER Instituto Médico - Quilmes, Buenos Aires
Recruiting
Fundación CIDEA - Buenos Aires
Recruiting
Consultora Integral de Salud SRL - Centro Médico Privado
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Aprillus Asistencia e Investigación
Recruiting
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
Hospital De Base de São José do Rio Preto - CIP São José
Recruiting
Clínica IBIS - Medicina, Reumatologia e Dermatologia LTDA
Recruiting
CEMEC - Centro Multidisciplinar de Estudos Clínicos
Recruiting
Healthy Medical Center
Recruiting
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04895696
