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

NCT04895696 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IM026-0242023-504320-25-00U1111-1241-6528
• Study Type: interventional
• Target: 268
• Locations: 19 countries
• Sites: 147

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

Keywords

BMS-986256; Systemic Lupus Erythematosus; SLE; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Afimetoran

Outcome Measures

Primary Outcomes (1)

• Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48

  Up to 48 Weeks

Secondary Outcomes (16)

• Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48

  Up to 48 Weeks

• Proportion of participants who achieve an SRI(4) response at Week 24

  Up to 24 Weeks

• Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48

  Up to 48 Weeks

• Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48

  Up to 48 Weeks

• Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48

  Up to 48 Weeks

Study Arms (4)

Afimetoran: Dose 1

EXPERIMENTAL

Drug: Afimetoran

Afimetoran: Dose 2

EXPERIMENTAL

Drug: Afimetoran

Afimetoran: Dose 3

EXPERIMENTAL

Drug: Afimetoran

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Afimetoran DRUG

Specified dose on specified days

Also known as: BMS-986256

Afimetoran: Dose 1; Afimetoran: Dose 2; Afimetoran: Dose 3

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (147)

Local Institution - 0100

Birmingham, Alabama, 35205, United States

Location

Local Institution - 0123

Huntington Beach, California, 92648, United States

Location

Local Institution - 0170

La Jolla, California, 92037, United States

Location

Local Institution - 0159

La Palma, California, 90623, United States

Location

Local Institution - 0172

San Diego, California, 92128, United States

Location

Local Institution - 0164

Woodland Hills, California, 91364, United States

Location

Local Institution - 0121

Clearwater, Florida, 33765, United States

Location

Local Institution - 0167

Kissimmee, Florida, 34741, United States

Location

Local Institution - 0122

Orlando, Florida, 32808, United States

Location

Local Institution - 0173

Ormond Beach, Florida, 32174, United States

Location

Local Institution - 0154

Plantation, Florida, 33324, United States

Location

Local Institution - 0137

South Miami, Florida, 33143, United States

Location

Local Institution - 0155

Tamarac, Florida, 33321, United States

Location

Local Institution - 0160

Atlanta, Georgia, 30318, United States

Location

Local Institution - 0205

Suwanee, Georgia, 30024, United States

Location

Local Institution - 0146

Orland Park, Illinois, 60467, United States

Location

Local Institution - 0187

Hopkinsville, Kentucky, 42240, United States

Location

Local Institution - 0171

Baton Rouge, Louisiana, 70836, United States

Location

Local Institution - 0134

Wheaton, Maryland, 20902, United States

Location

Local Institution - 0070

Eagan, Minnesota, 55121, United States

Location

Local Institution - 0124

St Louis, Missouri, 63110, United States

Location

Local Institution - 0165

St Louis, Missouri, 63141, United States

Location

Local Institution - 0091

Las Vegas, Nevada, 89128, United States

Location

Local Institution - 0219

West Long Branch, New Jersey, 07764, United States

Location

Local Institution - 0140

Manhasset, New York, 11030, United States

Location

Local Institution - 0132

The Bronx, New York, 10461, United States

Location

Local Institution - 0203

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0103

Charlotte, North Carolina, 28211, United States

Location

Local Institution - 0151

Columbus, Ohio, 43203, United States

Location

Local Institution - 0042

Middleburg Heights, Ohio, 44130, United States

Location

Local Institution - 0152

Allen, Texas, 75013, United States

Location

Local Institution - 0197

Allen, Texas, 75013, United States

Location

Local Institution - 0136

Amarillo, Texas, 79124, United States

Location

Local Institution - 0029

Mesquite, Texas, 75150, United States

Location

Local Institution - 0163

San Antonio, Texas, 78215, United States

Location

Local Institution - 0223

Bellevue, Washington, 98004, United States

Location

Local Institution - 0130

Quilmes, Buenos Aires, 1878, Argentina

Location

Local Institution - 0195

San Fernando, Buenos Aires, 1646, Argentina

Location

Local Institution - 0025

Córdoba, Córdoba Province, 5004, Argentina

Location

Local Institution - 0074

Buenos Aires, Distrito Federal, C1121ABE, Argentina

Location

Local Institution - 0040

CABA, Distrito Federal, 1406, Argentina

Location

Local Institution - 0027

San Miguel de Tucumán, Tucumán Province, T4000, Argentina

Location

Local Institution - 0207

Buenos Aires, 1425, Argentina

Location

Local Institution - 0128

Buenos Aires, C1426ABP, Argentina

Location

Local Institution - 0041

San Juan, 5400, Argentina

Location

Local Institution - 0063

Botany, New South Wales, 2019, Australia

Location

Local Institution - 0072

Westmead, New South Wales, 2145, Australia

Location

Local Institution - 0066

Maroochydore, Queensland, 4558, Australia

Location

Local Institution - 0065

Woodville, South Australia, 5011, Australia

Location

Local Institution - 0062

Camberwell, Victoria, 3124, Australia

Location

Local Institution - 0064

Ivanhoe, Victoria, 3079, Australia

Location

Local Institution - 0006

Salvador, Estado de Bahia, 40150-150, Brazil

Location

Local Institution - 0031

Salvador, Estado de Bahia, 41820-020, Brazil

Location

Local Institution - 0093

Cuiabá, Mato Grosso, 78020-500, Brazil

Location

Local Institution - 0008

Juiz de Fora, Minas Gerais, 36010-570, Brazil

Location

Local Institution - 0010

Curitiba, Paraná, 80030110, Brazil

Location

Local Institution - 0007

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Local Institution - 0014

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Local Institution - 0045

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Local Institution - 0009

São Paulo, 04266-010, Brazil

Location

Local Institution - 0127

Osorno, Los Lagos Region, 5290000, Chile

Location

Local Institution - 0143

Valdivia, Los Ríos Region, 2279374, Chile

Location

Local Institution - 0075

Providencia, Santiago Metropolitan, 7500504, Chile

Location

Local Institution - 0073

Santiago, Santiago Metropolitan, 0, Chile

Location

Local Institution - 0043

Santiago, Santiago Metropolitan, 7501126, Chile

Location

Local Institution - 0177

Beijing, Beijing Municipality, 100029, China

Location

Local Institution - 0180

Beijing, Beijing Municipality, 100144, China

Location

Local Institution - 0184

Shenzhen, Guangdong, 518107, China

Location

Local Institution - 0176

Nanjing, Jiangsu, 210000, China

Location

Local Institution - 0188

Nanjing, Jiangsu, 210029, China

Location

Local Institution - 0193

Suzhou, Jiangsu, 215006, China

Location

Local Institution - 0174

Changchun, Jilin, 130000, China

Location

Local Institution - 0179

Dalian, Liaoning, 116023, China

Location

Local Institution - 0178

Jinan, Shandong, 250012, China

Location

Local Institution - 0183

Jining, Shandong, 272011, China

Location

Local Institution - 0190

Medellín, Antioquia, 050021, Colombia

Location

Local Institution - 0001

Barranquilla, 080020, Colombia

Location

Local Institution - 0004

Bogotá, 110221, Colombia

Location

Local Institution - 0076

Cali, 760042, Colombia

Location

Local Institution - 0005

Chía, 250001, Colombia

Location

Local Institution - 0003

Zipaquirá, 250252, Colombia

Location

Local Institution - 0156

Pessac, Aquitaine, 33600, France

Location

Local Institution - 0083

Brest, Finistère, 29609, France

Location

Local Institution - 0048

Bordeaux, 33076, France

Location

Local Institution - 0144

Caen, 14033, France

Location

Local Institution - 0129

Lille, 59037, France

Location

Local Institution - 0112

Marseille, 13003, France

Location

Local Institution - 0044

Strasbourg, 67098, France

Location

Local Institution - 0087

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Local Institution - 0085

Berlin, 10117, Germany

Location

Local Institution - 0086

Essen, 45122, Germany

Location

Local Institution - 0084

Freiburg im Breisgau, 79106, Germany

Location

Local Institution - 0226

Ahmedabad, Gujarat, 380015, India

Location

Local Institution - 0214

Gurugram, Haryana, 122001, India

Location

Local Institution - 0210

Bengaluru, Karnataka, 560010, India

Location

Local Institution - 0208

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Local Institution - 0209

Secunderabad, Telangana, 500003, India

Location

Local Institution - 0119

Manorhamilton, Leitrim, 0, Ireland

Location

Local Institution - 0106

Dublin, D15 X40D, Ireland

Location

Local Institution - 0107

Galway, H91 TY80, Ireland

Location

Local Institution - 0114

Eiheiji-cho,Yoshida-gun, Fukui, 910-1193, Japan

Location

Local Institution - 0095

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Local Institution - 0096

Sapporo, Hokkaido, 060-8648, Japan

Location

Local Institution - 0104

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Local Institution - 0099

Sendai, Miyagi, 980-8574, Japan

Location

Local Institution - 0117

Bunkyo-ku, Tokyo, 1138431, Japan

Location

Local Institution - 0218

Fuchū, Tokyo, 1838524, Japan

Location

Local Institution - 0113

Itabashiku, Tokyo, 173-8610, Japan

Location

Local Institution - 0150

Meguro-ku, Tokyo, 1538515, Japan

Location

Local Institution - 0098

Shinjuku-ku, Tokyo, 1600035, Japan

Location

Local Institution - 0105

Shinjuku-ku, Tokyo, 1628655, Japan

Location

Local Institution - 0138

Aichi, 457-8511, Japan

Location

Local Institution - 0115

Chiba, 260-8712, Japan

Location

Local Institution - 0162

Fukushima, 960-1295, Japan

Location

Local Institution - 0097

Tokyo, 104-8560, Japan

Location

Local Institution - 0116

Tokyo, 113-8654, Japan

Location

Local Institution - 0020

León, Guanajuato, 37000, Mexico

Location

Local Institution - 0017

Guadalajara, Jalisco, 44650, Mexico

Location

Local Institution - 0022

Zapopan, Jalisco, 45070, Mexico

Location

Local Institution - 0060

Mexico City, Mexico City, 06760, Mexico

Location

Local Institution - 0018

Mexico City, Mexico City, 11850, Mexico

Location

Local Institution - 0071

Monterrey, Nuevo León, 64000, Mexico

Location

Local Institution - 0021

Chihuahua City, 31210, Mexico

Location

Local Institution - 0158

Mexico City, 14080, Mexico

Location

Local Institution - 0061

Mérida, 97070, Mexico

Location

Local Institution - 0204

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Local Institution - 0049

Poznan, 60-218, Poland

Location

Local Institution - 0149

Warsaw, 00-874, Poland

Location

Local Institution - 0052

Wroclaw, 50-556, Poland

Location

Local Institution - 0037

San Juan, 00917, Puerto Rico

Location

Local Institution - 0082

Râmnicu Vâlcea, Vâlcea County, 247065, Romania

Location

Local Institution - 0157

Bucharest, 011053, Romania

Location

Local Institution - 0067

Bucharest, 011172, Romania

Location

Local Institution - 0068

Giroc, 307220, Romania

Location

Local Institution - 0206

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0056

A Coruña, 15006, Spain

Location

Local Institution - 0058

Barcelona, 08035, Spain

Location

Local Institution - 0055

Madrid, 28009, Spain

Location

Local Institution - 0057

Seville, 41014, Spain

Location

Local Institution - 0080

Kaohsiung Niao Sung Dist, 83301, Taiwan

Location

Local Institution - 0081

Taichung, 404, Taiwan

Location

Local Institution - 0078

Taichung, 407, Taiwan

Location

Local Institution - 0079

Taipei, 10002, Taiwan

Location

Local Institution - 0077

Taipei, 11217, Taiwan

Location

Local Institution - 0111

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

Local Institution - 0110

Bradford, BD5 0NA, United Kingdom

Location

Local Institution - 0125

Manchester, M13 9WL, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 20, 2021
• Study Start: October 11, 2021
• Primary Completion: March 29, 2026
• Study Completion (Estimated): April 22, 2029
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

CO (6); TW (5); FR (7); ME (9); DE (4); JP (16); PL (4); CN (10); AR (9); RO (4); BR (9); US (36); IE (3); IN (5); GB (3); AU (6); CL (5); PR (1); ES (5)