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

NCT ID: NCT04895696

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 268 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-11
• Study Completion Date: 2029-04-22

Brief 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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Afimetoran: Dose 1

Group Type: EXPERIMENTAL

Afimetoran

Intervention Type: DRUG

Specified dose on specified days

Afimetoran: Dose 2

Group Type: EXPERIMENTAL

Afimetoran

Intervention Type: DRUG

Specified dose on specified days

Afimetoran: Dose 3

Group Type: EXPERIMENTAL

Afimetoran

Intervention Type: DRUG

Specified dose on specified days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Specified dose on specified days

Interventions

Afimetoran

Specified dose on specified days

Intervention Type: DRUG

Placebo

Specified dose on specified days

Intervention Type: OTHER

Other Intervention Names

BMS-986256

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution - 0100

Birmingham, Alabama, United States

Local Institution - 0123

Huntington Beach, California, United States

Local Institution - 0170

La Jolla, California, United States

Local Institution - 0159

La Palma, California, United States

Local Institution - 0172

San Diego, California, United States

Local Institution - 0164

Woodland Hills, California, United States

Local Institution - 0121

Clearwater, Florida, United States

Local Institution - 0167

Kissimmee, Florida, United States

Local Institution - 0122

Orlando, Florida, United States

Local Institution - 0173

Ormond Beach, Florida, United States

Local Institution - 0154

Plantation, Florida, United States

Local Institution - 0137

South Miami, Florida, United States

Local Institution - 0155

Tamarac, Florida, United States

Local Institution - 0160

Atlanta, Georgia, United States

Local Institution - 0205

Suwanee, Georgia, United States

Local Institution - 0146

Orland Park, Illinois, United States

Local Institution - 0187

Hopkinsville, Kentucky, United States

Local Institution - 0171

Baton Rouge, Louisiana, United States

Local Institution - 0134

Wheaton, Maryland, United States

Local Institution - 0070

Eagan, Minnesota, United States

Local Institution - 0124

St Louis, Missouri, United States

Local Institution - 0165

St Louis, Missouri, United States

Local Institution - 0091

Las Vegas, Nevada, United States

Local Institution - 0219

West Long Branch, New Jersey, United States

Local Institution - 0140

Manhasset, New York, United States

Local Institution - 0132

The Bronx, New York, United States

Local Institution - 0203

Charlotte, North Carolina, United States

Local Institution - 0103

Charlotte, North Carolina, United States

Local Institution - 0151

Columbus, Ohio, United States

Local Institution - 0042

Middleburg Heights, Ohio, United States

Local Institution - 0152

Allen, Texas, United States

Local Institution - 0197

Allen, Texas, United States

Local Institution - 0136

Amarillo, Texas, United States

Local Institution - 0029

Mesquite, Texas, United States

Local Institution - 0163

San Antonio, Texas, United States

Local Institution - 0223

Bellevue, Washington, United States

Local Institution - 0130

Quilmes, Buenos Aires, Argentina

Local Institution - 0195

San Fernando, Buenos Aires, Argentina

Local Institution - 0025

Córdoba, Córdoba Province, Argentina

Local Institution - 0074

Buenos Aires, Distrito Federal, Argentina

Local Institution - 0040

CABA, Distrito Federal, Argentina

Local Institution - 0027

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0207

Buenos Aires, , Argentina

Local Institution - 0128

Buenos Aires, , Argentina

Local Institution - 0041

San Juan, , Argentina

Local Institution - 0063

Botany, New South Wales, Australia

Local Institution - 0072

Westmead, New South Wales, Australia

Local Institution - 0066

Maroochydore, Queensland, Australia

Local Institution - 0065

Woodville, South Australia, Australia

Local Institution - 0062

Camberwell, Victoria, Australia

Local Institution - 0064

Ivanhoe, Victoria, Australia

Local Institution - 0006

Salvador, Estado de Bahia, Brazil

Local Institution - 0031

Salvador, Estado de Bahia, Brazil

Local Institution - 0093

Cuiabá, Mato Grosso, Brazil

Local Institution - 0008

Juiz de Fora, Minas Gerais, Brazil

Local Institution - 0010

Curitiba, Paraná, Brazil

Local Institution - 0007

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 0014

São Bernardo do Campo, São Paulo, Brazil

Local Institution - 0045

São José do Rio Preto, São Paulo, Brazil

Local Institution - 0009

São Paulo, , Brazil

Local Institution - 0127

Osorno, Los Lagos Region, Chile

Local Institution - 0143

Valdivia, Los Ríos Region, Chile

Local Institution - 0075

Providencia, Santiago Metropolitan, Chile

Local Institution - 0073

Santiago, Santiago Metropolitan, Chile

Local Institution - 0043

Santiago, Santiago Metropolitan, Chile

Local Institution - 0177

Beijing, Beijing Municipality, China

Local Institution - 0180

Beijing, Beijing Municipality, China

Local Institution - 0184

Shenzhen, Guangdong, China

Local Institution - 0176

Nanjing, Jiangsu, China

Local Institution - 0188

Nanjing, Jiangsu, China

Local Institution - 0193

Suzhou, Jiangsu, China

Local Institution - 0174

Changchun, Jilin, China

Local Institution - 0179

Dalian, Liaoning, China

Local Institution - 0178

Jinan, Shandong, China

Local Institution - 0183

Jining, Shandong, China

Local Institution - 0190

Medellín, Antioquia, Colombia

Local Institution - 0001

Barranquilla, , Colombia

Local Institution - 0004

Bogotá, , Colombia

Local Institution - 0076

Cali, , Colombia

Local Institution - 0005

Chía, , Colombia

Local Institution - 0003

Zipaquirá, , Colombia

Local Institution - 0156

Pessac, Aquitaine, France

Local Institution - 0083

Brest, Finistère, France

Local Institution - 0048

Bordeaux, , France

Local Institution - 0144

Caen, , France

Local Institution - 0129

Lille, , France

Local Institution - 0112

Marseille, , France

Local Institution - 0044

Strasbourg, , France

Local Institution - 0087

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0085

Berlin, , Germany

Local Institution - 0086

Essen, , Germany

Local Institution - 0084

Freiburg im Breisgau, , Germany

Local Institution - 0226

Ahmedabad, Gujarat, India

Local Institution - 0214

Gurugram, Haryana, India

Local Institution - 0210

Bengaluru, Karnataka, India

Local Institution - 0208

New Delhi, National Capital Territory of Delhi, India

Local Institution - 0209

Secunderabad, Telangana, India

Local Institution - 0119

Manorhamilton, Leitrim, Ireland

Local Institution - 0106

Dublin, , Ireland

Local Institution - 0107

Galway, , Ireland

Local Institution - 0114

Eiheiji-cho,Yoshida-gun, Fukui, Japan

Local Institution - 0095

Kitakyushu, Fukuoka, Japan

Local Institution - 0096

Sapporo, Hokkaido, Japan

Local Institution - 0104

Kanazawa, Ishikawa-ken, Japan

Local Institution - 0099

Sendai, Miyagi, Japan

Local Institution - 0117

Bunkyo-ku, Tokyo, Japan

Local Institution - 0218

Fuchū, Tokyo, Japan

Local Institution - 0113

Itabashiku, Tokyo, Japan

Local Institution - 0150

Meguro-ku, Tokyo, Japan

Local Institution - 0098

Shinjuku-ku, Tokyo, Japan

Local Institution - 0105

Shinjuku-ku, Tokyo, Japan

Local Institution - 0138

Aichi, , Japan

Local Institution - 0115

Chiba, , Japan

Local Institution - 0162

Fukushima, , Japan

Local Institution - 0097

Tokyo, , Japan

Local Institution - 0116

Tokyo, , Japan

Local Institution - 0020

León, Guanajuato, Mexico

Local Institution - 0017

Guadalajara, Jalisco, Mexico

Local Institution - 0022

Zapopan, Jalisco, Mexico

Local Institution - 0060

Mexico City, Mexico City, Mexico

Local Institution - 0018

Mexico City, Mexico City, Mexico

Local Institution - 0071

Monterrey, Nuevo León, Mexico

Local Institution - 0021

Chihuahua City, , Mexico

Local Institution - 0158

Mexico City, , Mexico

Local Institution - 0061

Mérida, , Mexico

Local Institution - 0204

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0049

Poznan, , Poland

Local Institution - 0149

Warsaw, , Poland

Local Institution - 0052

Wroclaw, , Poland

Local Institution - 0037

San Juan, , Puerto Rico

Local Institution - 0082

Râmnicu Vâlcea, Vâlcea County, Romania

Local Institution - 0157

Bucharest, , Romania

Local Institution - 0067

Bucharest, , Romania

Local Institution - 0068

Giroc, , Romania

Local Institution - 0206

Santander, Cantabria, Spain

Local Institution - 0056

A Coruña, , Spain

Local Institution - 0058

Barcelona, , Spain

Local Institution - 0055

Madrid, , Spain

Local Institution - 0057

Seville, , Spain

Local Institution - 0080

Kaohsiung Niao Sung Dist, , Taiwan

Local Institution - 0081

Taichung, , Taiwan

Local Institution - 0078

Taichung, , Taiwan

Local Institution - 0079

Taipei, , Taiwan

Local Institution - 0077

Taipei, , Taiwan

Local Institution - 0111

Cambridge, Cambridgeshire, United Kingdom

Local Institution - 0110

Bradford, , United Kingdom

Local Institution - 0125

Manchester, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Chile; China; Colombia; France; Germany; India; Ireland; Japan; Mexico; Poland; Puerto Rico; Romania; Spain; Taiwan; United Kingdom

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT04895696.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

2023-504320-25-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1241-6528

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM026-024

Identifier Type: -

Identifier Source: org_study_id