A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis

Bristol-Myers Squibb (BMS)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Arthritis, Rheumatoid

Treatments: Drug: BMS-986528

Study type: Interventional

Funder types: Industry

Identifiers

NCT07412704

2025-520666-22 (Other Identifier)

IM062-0001

U1111-1317-6393 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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84 participants in 10 patient groups

Cohort A1

Experimental group

Treatment:

Drug: BMS-986528

Cohort A2

Experimental group

Treatment:

Drug: BMS-986528

Cohort A3

Experimental group

Treatment:

Drug: BMS-986528

Cohort A4

Experimental group

Treatment:

Drug: BMS-986528

Cohort A5

Experimental group

Treatment:

Drug: BMS-986528

Cohort A6

Experimental group

Treatment:

Drug: BMS-986528

Cohort A7

Experimental group

Treatment:

Drug: BMS-986528

Cohort A8

Experimental group

Treatment:

Drug: BMS-986528

Cohort B1

Experimental group

Treatment:

Drug: BMS-986528

Cohort B2

Experimental group

Treatment:

Drug: BMS-986528