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Systemic Lupus ErythematosusPhase 2NCT04895696

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

A Phase 2 study testing Afimetoran in people with Systemic Lupus Erythematosus, run by Beeline Medicines Corporation at 147 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Afimetoran
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
147 sitesin 19 countries
Study dates
11 Oct 2021to 22 Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

147 sites in 19 countries.

147 sites in 19 countries

United States36 sites

  • Local Institution - 0152

    Allen, Texas, 75013

  • Local Institution - 0197

    Allen, Texas, 75013

  • Local Institution - 0136

    Amarillo, Texas, 79124

  • Local Institution - 0160

    Atlanta, Georgia, 30318

  • Local Institution - 0171

    Baton Rouge, Louisiana, 70836

  • Local Institution - 0223

    Bellevue, Washington, 98004

  • Local Institution - 0100

    Birmingham, Alabama, 35205

  • Local Institution - 0203

    Charlotte, North Carolina, 28204

  • Local Institution - 0103

    Charlotte, North Carolina, 28211

  • Local Institution - 0121

    Clearwater, Florida, 33765

  • Local Institution - 0151

    Columbus, Ohio, 43203

  • Local Institution - 0070

    Eagan, Minnesota, 55121

  • Local Institution - 0187

    Hopkinsville, Kentucky, 42240

  • Local Institution - 0123

    Huntington Beach, California, 92648

  • Local Institution - 0167

    Kissimmee, Florida, 34741

  • Local Institution - 0170

    La Jolla, California, 92037

  • Local Institution - 0159

    La Palma, California, 90623

  • Local Institution - 0091

    Las Vegas, Nevada, 89128

  • Local Institution - 0140

    Manhasset, New York, 11030

  • Local Institution - 0029

    Mesquite, Texas, 75150

  • Local Institution - 0042

    Middleburg Heights, Ohio, 44130

  • Local Institution - 0146

    Orland Park, Illinois, 60467

  • Local Institution - 0122

    Orlando, Florida, 32808

  • Local Institution - 0173

    Ormond Beach, Florida, 32174

  • Local Institution - 0154

    Plantation, Florida, 33324

  • Local Institution - 0163

    San Antonio, Texas, 78215

  • Local Institution - 0172

    San Diego, California, 92128

  • Local Institution - 0137

    South Miami, Florida, 33143

  • Local Institution - 0124

    St Louis, Missouri, 63110

  • Local Institution - 0165

    St Louis, Missouri, 63141

  • Local Institution - 0205

    Suwanee, Georgia, 30024

  • Local Institution - 0155

    Tamarac, Florida, 33321

  • Local Institution - 0132

    The Bronx, New York, 10461

  • Local Institution - 0219

    West Long Branch, New Jersey, 07764

  • Local Institution - 0134

    Wheaton, Maryland, 20902

  • Local Institution - 0164

    Woodland Hills, California, 91364

Other trials in United States

Japan16 sites

  • Local Institution - 0138

    Aichi, 457-8511

  • Local Institution - 0117

    Bunkyo-ku, Tokyo, 1138431

  • Local Institution - 0115

    Chiba, Chiba, 260-8712

  • Local Institution - 0114

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

  • Local Institution - 0218

    Fuchū, Tokyo, 1838524

  • Local Institution - 0162

    Fukushima, Fukushima, 960-1295

  • Local Institution - 0104

    Kanazawa, Ishikawa-ken, 920-8641

  • Local Institution - 0095

    Kitakyushu, Fukuoka, 807-8556

  • Local Institution - 0150

    Meguro-ku, Tokyo, 1538515

  • Local Institution - 0096

    Sapporo, Hokkaido, 060-8648

  • Local Institution - 0099

    Sendai, Miyagi, 980-8574

  • Local Institution - 0098

    Shinjuku-ku, Tokyo, 1600035

  • Local Institution - 0105

    Shinjuku-ku, Tokyo, 1628655

  • Local Institution - 0113

    tabashi City, Tokyo, 173-8610

  • Local Institution - 0097

    Tokyo, Tokyo, 104-8560

  • Local Institution - 0116

    Tokyo, Tokyo, 113-8654

Other trials in Japan

China10 sites

  • Local Institution - 0177

    Beijing, Beijing Municipality, 100029

  • Local Institution - 0180

    Beijing, Beijing Municipality, 100144

  • Local Institution - 0174

    Changchun, Jilin, 130000

  • Local Institution - 0179

    Dalian, Liaoning, 116023

  • Local Institution - 0178

    Jinan, Shandong, 250012

  • Local Institution - 0183

    Jining, Shandong, 272011

  • Local Institution - 0176

    Nanjing, Jiangsu, 210000

  • Local Institution - 0188

    Nanjing, Jiangsu, 210029

  • Local Institution - 0184

    Shenzhen, Guangdong, 518107

  • Local Institution - 0193

    Suzhou, Jiangsu, 215006

Other trials in China

Argentina9 sites

  • Local Institution - 0207

    Buenos Aires, Buenos Aires, 1425

  • Local Institution - 0128

    Buenos Aires, Buenos Aires, C1426ABP

  • Local Institution - 0074

    Buenos Aires, Distrito Federal, C1121ABE

  • Local Institution - 0040

    CABA, Distrito Federal, 1406

  • Local Institution - 0025

    Córdoba, Córdoba Province, 5004

  • Local Institution - 0130

    Quilmes, Buenos Aires, 1878

  • Local Institution - 0195

    San Fernando, Buenos Aires, 1646

  • Local Institution - 0041

    San Juan, San Juan Province, 5400

  • Local Institution - 0027

    San Miguel de Tucumán, Tucumán Province, T4000

Other trials in Argentina

Brazil9 sites

  • Local Institution - 0093

    Cuiabá, Mato Grosso, 78020-500

  • Local Institution - 0010

    Curitiba, Paraná, 80030110

  • Local Institution - 0008

    Juiz de Fora, Minas Gerais, 36010-570

  • Local Institution - 0007

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Local Institution - 0006

    Salvador, Estado de Bahia, 40150-150

  • Local Institution - 0031

    Salvador, Estado de Bahia, 41820-020

  • Local Institution - 0014

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0045

    São José do Rio Preto, São Paulo, 15090000

  • Local Institution - 0009

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Mexico9 sites

  • Local Institution - 0021

    Chihuahua City, Chihuahua, 31210

  • Local Institution - 0017

    Guadalajara, Jalisco, 44650

  • Local Institution - 0020

    León, Guanajuato, 37000

  • Local Institution - 0061

    Mérida, Merida, 97070

  • Local Institution - 0060

    Mexico City, Mexico City, 06760

  • Local Institution - 0018

    Mexico City, Mexico City, 11850

  • Local Institution - 0158

    Mexico City, 14080

  • Local Institution - 0071

    Monterrey, Nuevo León, 64000

  • Local Institution - 0022

    Zapopan, Jalisco, 45070

Other trials in Mexico

France7 sites

  • Local Institution - 0048

    Bordeaux, 33076

  • Local Institution - 0083

    Brest, Finistère, 29609

  • Local Institution - 0144

    Caen, 14033

  • Local Institution - 0129

    Lille, 59037

  • Local Institution - 0112

    Marseille, 13003

  • Local Institution - 0156

    Pessac, Aquitaine, 33600

  • Local Institution - 0044

    Strasbourg, 67098

Other trials in France

Australia6 sites

  • Local Institution - 0063

    Botany, New South Wales, 2019

  • Local Institution - 0062

    Camberwell, Victoria, 3124

  • Local Institution - 0064

    Ivanhoe, Victoria, 3079

  • Local Institution - 0066

    Maroochydore, Queensland, 4558

  • Local Institution - 0072

    Westmead, New South Wales, 2145

  • Local Institution - 0065

    Woodville, South Australia, 5011

Other trials in Australia

Colombia6 sites

  • Local Institution - 0001

    Barranquilla, 080020

  • Local Institution - 0004

    Bogotá, 110221

  • Local Institution - 0076

    Cali, 760042

  • Local Institution - 0005

    Chía, 250001

  • Local Institution - 0190

    Medellín, Antioquia, 050021

  • Local Institution - 0003

    Zipaquirá, 250252

Other trials in Colombia

Chile5 sites

  • Local Institution - 0127

    Osorno, Los Lagos Region, 5290000

  • Local Institution - 0075

    Providencia, Santiago Metropolitan, 7500504

  • Local Institution - 0073

    Santiago, Santiago Metropolitan, 0

  • Local Institution - 0043

    Santiago, Santiago Metropolitan, 7501126

  • Local Institution - 0143

    Valdivia, Los Ríos Region, 2279374

Other trials in Chile

India5 sites

  • Local Institution - 0226

    Ahmedabad, Gujarat, 380015

  • Local Institution - 0210

    Bengaluru, Karnataka, 560010

  • Local Institution - 0214

    Gurugram, Haryana, 122001

  • Local Institution - 0208

    New Delhi, National Capital Territory of Delhi, 110029

  • Local Institution - 0209

    Secunderabad, Telangana, 500003

Other trials in India

Spain5 sites

  • Local Institution - 0056

    A Coruña, 15006

  • Local Institution - 0058

    Barcelona, 08035

  • Local Institution - 0055

    Madrid, 28009

  • Local Institution - 0206

    Santander, Cantabria, 39008

  • Local Institution - 0057

    Seville, 41014

Other trials in Spain

Taiwan5 sites

  • Local Institution - 0080

    Kaohsiung Niao Sung Dist, 83301

  • Local Institution - 0081

    Taichung, 404

  • Local Institution - 0078

    Taichung, 407

  • Local Institution - 0079

    Taipei, 10002

  • Local Institution - 0077

    Taipei, 11217

Other trials in Taiwan

Germany4 sites

  • Local Institution - 0085

    Berlin, 10117

  • Local Institution - 0087

    Cologne, North Rhine-Westphalia, 50937

  • Local Institution - 0086

    Essen, 45122

  • Local Institution - 0084

    Freiburg im Breisgau, 79106

Other trials in Germany

Poland4 sites

  • Local Institution - 0049

    Poznan, 60-218

  • Local Institution - 0204

    Warsaw, Masovian Voivodeship, 02-665

  • Local Institution - 0149

    Warsaw, 00-874

  • Local Institution - 0052

    Wroclaw, 50-556

Other trials in Poland

Romania4 sites

  • Local Institution - 0157

    Bucharest, 011053

  • Local Institution - 0067

    Bucharest, 011172

  • Local Institution - 0068

    Giroc, 307220

  • Local Institution - 0082

    Râmnicu Vâlcea, Vâlcea County, 247065

Other trials in Romania

Ireland3 sites

  • Local Institution - 0106

    Dublin, Dublin, D15 X40D

  • Local Institution - 0107

    Galway, GALWAY, H91 TY80

  • Local Institution - 0119

    Manorhamilton, LEITRIM, 0

Other trials in Ireland

United Kingdom3 sites

  • Local Institution - 0110

    Bradford, BD5 0NA

  • Local Institution - 0111

    Cambridge, Cambridgeshire, CB2 2QQ

  • Local Institution - 0125

    Manchester, M13 9WL

Other trials in United Kingdom

Puerto Rico1 site

  • Local Institution - 0037

    San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Afimetoran, Placebo
Keywords
BMS-986256, Systemic Lupus Erythematosus, SLE, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases, Afimetoran
Medical subject headings
Lupus Erythematosus, Systemic, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfimetoranDrug

    Also called BMS-986256

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT04895696
Study groupRoleWhat they receive
Afimetoran: Dose 1ExperimentalNot described
Receives: Drug: Afimetoran
Afimetoran: Dose 2ExperimentalNot described
Receives: Drug: Afimetoran
Afimetoran: Dose 3ExperimentalNot described
Receives: Drug: Afimetoran
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 48 Weeks

Secondary outcomes (16)

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

    Measured: Up to 48 Weeks

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

    Measured: Up to 24 Weeks

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

    Measured: Up to 48 Weeks

  4. 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

    Measured: Up to 48 Weeks

  5. 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

    Measured: Up to 48 Weeks

  6. 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

    Measured: Up to 48 Weeks

  7. 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

    Measured: Up to 48 Weeks

  8. Change from baseline in PGA score of disease activity at Week 24 and Week 48

    PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)

    Measured: Up to 48 Weeks

  9. Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48

    Measured: Up to 48 Weeks

  10. 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)

    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.

    Measured: Up to 48 Weeks

  11. Number of participants with Adverse Events (AEs)

    Measured: Up to 100 Weeks

  12. Number of participants with Serious Adverse Events (SAEs)

    Measured: Up to 100 Weeks

  13. Number of participants with clinical laboratory abnormalities

    Measured: Up to 100 Weeks

  14. Number of participants with physical examination abnormalities

    Measured: Up to 100 Weeks

  15. Number of participants with vital sign abnormalities

    Measured: Up to 100 Weeks

  16. Number of participants with electrocardiogram (ECG) abnormalities

    Measured: Up to 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start11 Oct 2021
  3. Primary completion12 Jun 2026
  4. Study completion22 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895696
Sponsor's protocol ID
IM026-024
Other IDs
2023-504320-25-00, U1111-1241-6528, 2023
Status last verified
Aug 2026
First submitted
19 May 2021
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Afimetoran in people with Systemic Lupus Erythematosus, run by Beeline Medicines Corporation at 147 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Japan, China, Argentina, Brazil and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895696.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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