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NCT Number: NCT07412704

A Study 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).

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0048, Merksem, Flanders, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986528

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: Up to Week 54

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to Week 54

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Week 54

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Week 54

  3. 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

  4. Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Week 54

  5. Apparent terminal serum half-life (T-HALF)

    Time frame: Up to Week 54

  6. Apparent total body clearance (CLT/F)

    Time frame: Up to Week 54

  7. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Up to Week 54

  8. Change from baseline in numbers and fractions of B cells

    Time frame: Up to Week 54

  9. Change from baseline in immunoglobulin G (igG) levels

    Time frame: Up to Week 54

  10. Change from baseline in igM levels

    Time frame: Up to Week 54

  11. Change from baseline in igE levels

    Time frame: Up to Week 54

  12. Change from baseline in igD levels

    Time frame: Up to Week 54

  13. Change from baseline in igA levels

    Time frame: Up to Week 54

  14. Number of participants with anti-drug antibody (ADA)

    Time frame: Up to Week 54

  15. Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)

    Time frame: At Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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