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

May 12, 2026 updated by: Bristol-Myers Squibb

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

268

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Local Institution - 0207
      • Buenos Aires, Argentina, C1426ABP
        • Local Institution - 0128
      • San Juan, Argentina, 5400
        • Local Institution - 0041
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, 1878
        • Local Institution - 0130
      • San Fernando, Buenos Aires, Argentina, 1646
        • Local Institution - 0195
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5004
        • Local Institution - 0025
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, C1121ABE
        • Local Institution - 0074
      • CABA, Distrito Federal, Argentina, 1406
        • Local Institution - 0040
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Local Institution - 0027
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Local Institution - 0063
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0072
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Local Institution - 0066
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Local Institution - 0065
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Local Institution - 0062
      • Ivanhoe, Victoria, Australia, 3079
        • Local Institution - 0064
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Local Institution - 0009
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Local Institution - 0006
      • Salvador, Estado de Bahia, Brazil, 41820-020
        • Local Institution - 0031
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil, 78020-500
        • Local Institution - 0093
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Local Institution - 0008
    • Paraná
      • Curitiba, Paraná, Brazil, 80030110
        • Local Institution - 0010
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • Local Institution - 0007
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Local Institution - 0014
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Local Institution - 0045
  • Chile
    • Los Lagos Region
      • Osorno, Los Lagos Region, Chile, 5290000
        • Local Institution - 0127
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 2279374
        • Local Institution - 0143
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500504
        • Local Institution - 0075
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0073
      • Santiago, Santiago Metropolitan, Chile, 7501126
        • Local Institution - 0043
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Local Institution - 0177
      • Beijing, Beijing Municipality, China, 100144
        • Local Institution - 0180
    • Guangdong
      • Shenzhen, Guangdong, China, 518107
        • Local Institution - 0184
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0176
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0188
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0193
    • Jilin
      • Changchun, Jilin, China, 130000
        • Local Institution - 0174
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Local Institution - 0179
    • Shandong
      • Jinan, Shandong, China, 250012
        • Local Institution - 0178
      • Jining, Shandong, China, 272011
        • Local Institution - 0183
  • Colombia
      • Barranquilla, Colombia, 080020
        • Local Institution - 0001
      • Bogotá, Colombia, 110221
        • Local Institution - 0004
      • Cali, Colombia, 760042
        • Local Institution - 0076
      • Chía, Colombia, 250001
        • Local Institution - 0005
      • Zipaquirá, Colombia, 250252
        • Local Institution - 0003
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Local Institution - 0190
  • France
      • Bordeaux, France, 33076
        • Local Institution - 0048
      • Caen, France, 14033
        • Local Institution - 0144
      • Lille, France, 59037
        • Local Institution - 0129
      • Marseille, France, 13003
        • Local Institution - 0112
      • Strasbourg, France, 67098
        • Local Institution - 0044
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Local Institution - 0156
    • Finistère
      • Brest, Finistère, France, 29609
        • Local Institution - 0083
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 0085
      • Essen, Germany, 45122
        • Local Institution - 0086
      • Freiburg im Breisgau, Germany, 79106
        • Local Institution - 0084
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Local Institution - 0087
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Local Institution - 0226
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Local Institution - 0214
    • Karnataka
      • Bengaluru, Karnataka, India, 560010
        • Local Institution - 0210
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Local Institution - 0208
    • Telangana
      • Secunderabad, Telangana, India, 500003
        • Local Institution - 0209
  • Ireland
      • Dublin, Ireland, D15 X40D
        • Local Institution - 0106
      • Galway, Ireland, H91 TY80
        • Local Institution - 0107
    • Leitrim
      • Manorhamilton, Leitrim, Ireland
        • Local Institution - 0119
  • Japan
      • Aichi, Japan, 457-8511
        • Local Institution - 0138
      • Chiba, Japan, 260-8712
        • Local Institution - 0115
      • Fukushima, Japan, 960-1295
        • Local Institution - 0162
      • Tokyo, Japan, 104-8560
        • Local Institution - 0097
      • Tokyo, Japan, 113-8654
        • Local Institution - 0116
    • Fukui
      • Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
        • Local Institution - 0114
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Local Institution - 0095
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Local Institution - 0096
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Local Institution - 0104
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Local Institution - 0099
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138431
        • Local Institution - 0117
      • Fuchū, Tokyo, Japan, 1838524
        • Local Institution - 0218
      • Itabashiku, Tokyo, Japan, 173-8610
        • Local Institution - 0113
      • Meguro-ku, Tokyo, Japan, 1538515
        • Local Institution - 0150
      • Shinjuku-ku, Tokyo, Japan, 1600035
        • Local Institution - 0098
      • Shinjuku-ku, Tokyo, Japan, 1628655
        • Local Institution - 0105
  • Mexico
      • Chihuahua City, Mexico, 31210
        • Local Institution - 0021
      • Mexico City, Mexico, 14080
        • Local Institution - 0158
      • Mérida, Mexico, 97070
        • Local Institution - 0061
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Local Institution - 0020
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Local Institution - 0017
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0022
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06760
        • Local Institution - 0060
      • Mexico City, Mexico City, Mexico, 11850
        • Local Institution - 0018
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Local Institution - 0071
  • Poland
      • Poznan, Poland, 60-218
        • Local Institution - 0049
      • Warsaw, Poland, 00-874
        • Local Institution - 0149
      • Wroclaw, Poland, 50-556
        • Local Institution - 0052
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Local Institution - 0204
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Local Institution - 0037
  • Romania
      • Bucharest, Romania, 011053
        • Local Institution - 0157
      • Bucharest, Romania, 011172
        • Local Institution - 0067
      • Giroc, Romania, 307220
        • Local Institution - 0068
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romania, 247065
        • Local Institution - 0082
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0056
      • Barcelona, Spain, 08035
        • Local Institution - 0058
      • Madrid, Spain, 28009
        • Local Institution - 0055
      • Seville, Spain, 41014
        • Local Institution - 0057
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0206
  • Taiwan
      • Kaohsiung Niao Sung Dist, Taiwan, 83301
        • Local Institution - 0080
      • Taichung, Taiwan, 404
        • Local Institution - 0081
      • Taichung, Taiwan, 407
        • Local Institution - 0078
      • Taipei, Taiwan, 10002
        • Local Institution - 0079
      • Taipei, Taiwan, 11217
        • Local Institution - 0077
  • United Kingdom
      • Bradford, United Kingdom, BD5 0NA
        • Local Institution - 0110
      • Manchester, United Kingdom, M13 9WL
        • Local Institution - 0125
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Local Institution - 0111
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Local Institution - 0100
    • California
      • Huntington Beach, California, United States, 92648
        • Local Institution - 0123
      • La Jolla, California, United States, 92037
        • Local Institution - 0170
      • La Palma, California, United States, 90623
        • Local Institution - 0159
      • San Diego, California, United States, 92128
        • Local Institution - 0172
      • Woodland Hills, California, United States, 91364
        • Local Institution - 0164
    • Florida
      • Clearwater, Florida, United States, 33765
        • Local Institution - 0121
      • Kissimmee, Florida, United States, 34741
        • Local Institution - 0167
      • Orlando, Florida, United States, 32808
        • Local Institution - 0122
      • Ormond Beach, Florida, United States, 32174
        • Local Institution - 0173
      • Plantation, Florida, United States, 33324
        • Local Institution - 0154
      • South Miami, Florida, United States, 33143
        • Local Institution - 0137
      • Tamarac, Florida, United States, 33321
        • Local Institution - 0155
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Local Institution - 0160
      • Suwanee, Georgia, United States, 30024
        • Local Institution - 0205
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Local Institution - 0146
    • Kentucky
      • Hopkinsville, Kentucky, United States, 42240
        • Local Institution - 0187
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Local Institution - 0171
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Local Institution - 0134
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Local Institution - 0070
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0124
      • St Louis, Missouri, United States, 63141
        • Local Institution - 0165
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Local Institution - 0091
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • Local Institution - 0219
    • New York
      • Manhasset, New York, United States, 11030
        • Local Institution - 0140
      • The Bronx, New York, United States, 10461
        • Local Institution - 0132
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0203
      • Charlotte, North Carolina, United States, 28211
        • Local Institution - 0103
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Local Institution - 0151
      • Middleburg Heights, Ohio, United States, 44130
        • Local Institution - 0042
    • Texas
      • Allen, Texas, United States, 75013
        • Local Institution - 0152
      • Allen, Texas, United States, 75013
        • Local Institution - 0197
      • Amarillo, Texas, United States, 79124
        • Local Institution - 0136
      • Mesquite, Texas, United States, 75150
        • Local Institution - 0029
      • San Antonio, Texas, United States, 78215
        • Local Institution - 0163
    • Washington
      • Bellevue, Washington, United States, 98004
        • Local Institution - 0223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: Afimetoran: Dose 1
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Afimetoran: Dose 2
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Afimetoran: Dose 3
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
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
Time Frame: Up to 48 Weeks
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
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Change from baseline in PGA score of disease activity at Week 24 and Week 48
Time Frame: Up to 48 Weeks
PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)
Up to 48 Weeks
Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)
Time Frame: Up to 48 Weeks
The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.
Up to 48 Weeks
Number of participants with Adverse Events (AEs)
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with physical examination abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 52 Weeks
Up to 52 Weeks
Proportion of participants who achieve an SRI(4) response at Week 24
Time Frame: Up to 24 Weeks
Up to 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

April 22, 2029

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM026-024
  • U1111-1241-6528 (Registry Identifier: UTN)
  • 2023-504320-25-00 (Registry Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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