BMS-986528 in people with hard-to-treat rheumatoid arthritis
Official title: A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis
Run by Bristol-Myers Squibb · NCT07412704 · Data updated 2026-11-12
This study tests BMS-986528 to see if it is safe and tolerable and to gather early data on how it behaves in the body and whether it might slow rheumatoid arthritis.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 39 sites (La Jolla, California and 38 other locations) |
| Status | Recruiting |
| Started | October 6, 2026 |
| Main results expected | October 30, 2029 |
| Study ends | September 2, 2030 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07412704 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with rheumatoid arthritis characterized as difficult-to-treat who meet the study’s inclusion criteria.
✕Probably not a fit
Patients with non-responsive disease, contraindications to the drug, or those who do not tolerate the study treatment may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an early-phase interventional study evaluating BMS-986528 in adults with refractory rheumatoid arthritis. It aims to characterize safety, tolerability, pharmacokinetics and pharmacodynamics, and to gather preliminary evidence of disease-modifying activity. The trial includes phase 1/2 components and will be conducted at sites in California under Bristol-Myers Squibb sponsorship. Participants will receive BMS-986528 and will be assessed for adverse events, drug exposure, and signs of clinical response. The study excludes juvenile-onset arthritis, seronegative RA with possible polymyalgia rheumatica, and active fibromyalgia that could confound joint assessments.
Why it matters
Potential benefit: If successful, participants may experience improved disease control and a better safety/tolerability profile for BMS-986528.
How similar studies have gone: Prior early studies of similar agents have shown safety signals and pharmacokinetic data that justify further development in RA.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria \- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat. Exclusion Criteria * Juvenile arthritis or onset of inflammatory arthritis before age 18. * Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out. * Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment. * Other protocol-defined Inclusion/Exclusion criteria apply.
Where it's running
-
Colorado Blood Cancer Institute
Denver, Colorado, United States Recruiting -
Charité Research Organisation
Berlin, Germany Recruiting -
Rheumazentrum Ruhrgebiet
Herne, Germany Recruiting -
St. Josef-Stift Sendenhorst
Sendenhorst, Germany Recruiting -
Istituto Clinico Humanitas
Rozzano, Milano, Italy Recruiting -
Fondazione Policlinico Gemelli IRCCS
Roma, Italy Recruiting
Show 33 more locations
-
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], Spain Recruiting -
Hospital Universitario Reina Sofia
Córdoba, Spain Recruiting -
Universitaetsspital Bern - Inselspital
Bern, Switzerland Recruiting -
Hôpitaux Universitaire de Genève
Geneva, Switzerland Recruiting -
Local Institution - 0068
La Jolla, California, United States Not yet recruiting -
Local Institution - 0070
Loma Linda, California, United States Not yet recruiting -
Local Institution - 0069
Palo Alto, California, United States Not yet recruiting -
Local Institution - 0050
Aurora, Colorado, United States Not yet recruiting -
Local Institution - 0055
South Miami, Florida, United States Not yet recruiting -
Local Institution - 0081
New York, New York, United States Not yet recruiting -
Local Institution - 0079
New York, New York, United States Not yet recruiting -
Local Institution - 0066
Portland, Oregon, United States Not yet recruiting -
Local Institution - 0071
Philadelphia, Pennsylvania, United States Not yet recruiting -
Local Institution - 0051
DeSoto, Texas, United States Withdrawn -
Local Institution - 0048
Merksem, Flanders, Belgium Not yet recruiting -
Local Institution - 0049
Leuven, Belgium Not yet recruiting -
Local Institution - 0083
Aparecida de Goiânia, Goiás, Brazil Not yet recruiting -
Local Institution - 0033
Porto Alegre, Rio Grande do Sul, Brazil Not yet recruiting -
Local Institution - 0082
Valinhos, São Paulo, Brazil Not yet recruiting -
Local Institution - 0006
Beijing, Beijing Municipality, China Not yet recruiting -
Local Institution - 0080
Guangzhou, Guangdong, China Not yet recruiting -
Local Institution - 0010
Zhengzhou, Henan, China Not yet recruiting -
Local Institution - 0007
Nanchang, Jiangxi, China Not yet recruiting -
Local Institution - 0020
Shanghai, Shanghai Municipality, China Not yet recruiting -
Local Institution - 0001
Shanghai, Shanghai Municipality, China Not yet recruiting -
Local Institution - 0040
München, Bavaria, Germany Not yet recruiting -
Local Institution - 0021
Cologne, Germany Not yet recruiting -
Local Institution - 0053
México, Mexico Not yet recruiting -
Local Institution - 0023
Józefów, Masovian Voivodeship, Poland Not yet recruiting -
Local Institution - 0060
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine Not yet recruiting -
Local Institution - 0063
Poltava, Poltava Oblast, Ukraine Not yet recruiting -
Local Institution - 0064
Kyiv, Ukraine Not yet recruiting -
Local Institution - 0061
Ternopil, Ukraine Not yet recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Collarless Actis hip stem for cementless hip replacement in Asian patients
This study tests how well a collarless Actis hip stem works in adults undergoing primary hip replacement, focusing on outcomes over five years in an East Asian population.
-
Fucoidan for active rheumatoid arthritis
This trial will test whether fucoidan, a seaweed-derived SR-A inhibitor, can reduce disease activity in adults (18–65) with active rheumatoid arthritis who have moderate-to-high disease activity despite current treatment.
-
Abdominal vagus nerve stimulation for moderate to severe drug-refractory rheumatoid arthritis
This trial will try a small implanted device that stimulates the abdominal vagus nerve to see if it is safe and possibly helpful for adults whose moderate to severe rheumatoid arthritis has not responded to medicines.
-
Effects of phytocannabinoids on immune response in chronic inflammatory diseases
This study is testing whether phytocannabinoids like CBD and THC can help improve the immune response in people with chronic inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease.
-
Individualized tapering strategy for rheumatoid arthritis treatment
This study is testing a personalized plan for reducing medication in people with rheumatoid arthritis who are in remission to see if it helps prevent flare-ups.
-
Effects of a high-fiber diet on gut health and rheumatoid arthritis symptoms
This study is testing if a high-fiber diet can improve gut health and reduce symptoms for adults with rheumatoid arthritis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.