Recruiting
Phase 1
Phase 2

BMS-986528

Sponsor:

Bristol-Myers Squibb

Code:

NCT07412704

Conditions

Arthritis, Rheumatoid

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BMS-986528

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).

Conditions

Arthritis, Rheumatoid

Study ID

NCT07412704

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Sep 2, 2030

Anticipated

Primary completion date

Oct 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A1

experimental: Cohort A2

experimental: Cohort A3

experimental: Cohort A4

experimental: Cohort A5

experimental: Cohort A6

experimental: Cohort A7

experimental: Cohort A8

experimental: Cohort B1

experimental: Cohort B2

Interventions

BMS-986528

Specified dose on specified days

Primary outcome measure

  • Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to Week 54 ]
  • Number of participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Week 54 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Contacts

Richard Nash, Site 0067

303-981-2305

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.