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

February 20, 2026 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Local Institution - 0049
        • Contact:
          • Site 0049
    • Flanders
      • Merksem, Flanders, Belgium, 2170
        • Local Institution - 0048
        • Contact:
          • Site 0048
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100091
        • Local Institution - 0006
        • Contact:
          • Site 0006
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Local Institution - 0010
        • Contact:
          • Site 0010
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0007
        • Contact:
          • Site 0007
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Local Institution - 0020
        • Contact:
          • Site 0020
      • Shanghai, Shanghai Municipality, China, 200127
        • Local Institution - 0001
        • Contact:
          • Site 0001
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 0022
        • Contact:
          • Site 0022
      • Cologne, Germany, 50937
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Herne, Germany, 44652
        • Local Institution - 0028
        • Contact:
          • Site 0028
      • Potsdam, Germany, 14467
        • Local Institution - 0065
        • Contact:
          • Site 0065
    • Bavaria
      • München, Bavaria, Germany, 81377
        • Local Institution - 0040
        • Contact:
          • Site 0040
    • North Rhine-Westphalia
      • Sendenhorst, North Rhine-Westphalia, Germany, 48324
        • Local Institution - 0056
        • Contact:
          • Site 0056
  • Hungary
      • Budapest, Hungary, 1085
        • Local Institution - 0045
        • Contact:
          • Site 0045
  • Italy
      • Roma, Italy, 00168
        • Local Institution - 0017
        • Contact:
          • Site 0017
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Local Institution - 0019
        • Contact:
          • Site 0019
  • Poland
    • Masovian Voivodeship
      • Józefów, Masovian Voivodeship, Poland, 05-410
        • Local Institution - 0023
        • Contact:
          • Site 0023
  • Spain
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • Local Institution - 0039
        • Contact:
          • Site 0039
    • Córdoba
      • Córdoba, Córdoba, Spain, 14004
        • Local Institution - 0058
        • Contact:
          • Site 0058
  • Switzerland
      • Bern, Switzerland, 3010
        • Local Institution - 0037
        • Contact:
          • Site 0037
      • Geneva, Switzerland, 1211
        • Local Institution - 0027
        • Contact:
          • Site 0027
  • Ukraine
      • Kyiv, Ukraine, 02000
        • Local Institution - 0062
        • Contact:
          • Site 0062
      • Ternopil, Ukraine, 46002
        • Local Institution - 0061
        • Contact:
          • Site 0061
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Local Institution - 0060
        • Contact:
          • Site 0060
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ukraine, 01135
        • Local Institution - 0064
        • Contact:
          • Site 0064
    • Poltava Oblast
      • Poltava, Poltava Oblast, Ukraine, 36011
        • Local Institution - 0063
        • Contact:
          • Site 0063
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 0050
        • Contact:
          • Site 0050
    • Florida
      • South Miami, Florida, United States, 33143
        • Local Institution - 0055
        • Contact:
          • Site 0055
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 0066
        • Contact:
          • Site 0066
    • Texas
      • DeSoto, Texas, United States, 75115
        • Local Institution - 0051
        • Contact:
          • Site 0051
      • San Antonio, Texas, United States, 78229
        • Local Institution - 0057
        • Contact:
          • Site 0057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A1
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A2
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A3
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A4
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A5
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A6
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A7
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort A8
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort B1
Drug: BMS-986528
Specified dose on specified days
Experimental: Cohort B2
Drug: BMS-986528
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to Week 54
Up to Week 54
Time of maximum observed concentration (Tmax)
Time Frame: Up to Week 54
Up to Week 54
area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: Up to Week 54
Up to Week 54
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Up to Week 54
Up to Week 54
Apparent terminal serum half-life (T-HALF)
Time Frame: Up to Week 54
Up to Week 54
Apparent total body clearance (CLT/F)
Time Frame: Up to Week 54
Up to Week 54
Apparent volume of distribution of terminal phase (Vz/F)
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in numbers and fractions of B cells
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in immunoglobulin G (igG) levels
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in igM levels
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in igE levels
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in igD levels
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in igA levels
Time Frame: Up to Week 54
Up to Week 54
Number of participants with anti-drug antibody (ADA)
Time Frame: Up to Week 54
Up to Week 54
Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)
Time Frame: At Week 12
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 28, 2026

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

September 2, 2030

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM062-0001
  • 2025-520666-22 (Other Identifier: EU CTR)
  • U1111-1317-6393 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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