Clinical trial Recruiting at 10 sites Phase1; Phase2 Interventional Ages 18 to 65

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.

More Arthritis, Rheumatoid trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment84 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Locations39 sites (La Jolla, California and 38 other locations)
StatusRecruiting
StartedOctober 6, 2026
Main results expectedOctober 30, 2029
Study endsSeptember 2, 2030
Registry record updatedOctober 23, 2026
Trial IDNCT07412704 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.