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BMS-986528

Phase 1

Arthritis, Rheumatoid | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Aug 24, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986528 · 1 trial · 1 indication

Phase 1 1
NCT07412704A Study of BMS-986528 in Participants With Refractory Rheumatoid ArthritisArthritis, Rheumatoid
RECRUITING84 Analytics
PHASE1RECRUITING
A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis
Arthritis, Rheumatoid
NCT0741270484
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Maximum observed concentration (Cmax)
Up to Week 54
Time of maximum observed concentration (Tmax)
Up to Week 54
area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Week 54
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort A1EXPERIMENTAL -
Cohort A2EXPERIMENTAL -
Cohort A3EXPERIMENTAL -
Cohort A4EXPERIMENTAL -
Cohort A5EXPERIMENTAL -
Cohort A6EXPERIMENTAL -
Cohort A7EXPERIMENTAL -
Cohort A8EXPERIMENTAL -
Cohort B1EXPERIMENTAL -
Cohort B2EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986528DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites39

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. * Acti...

Countries:United StatesBelgiumBrazilChinaGermanyItalyMexicoPolandSpainSwitzerlandUkraine
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07412704Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07412704Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 17, 2026NCT07412704startDate: changed
LOWJul 17, 2026NCT07412704startDate: changed

Frequently asked questions about BMS-986528

What is BMS-986528 used for?

BMS-986528 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, with a study enrolling participants with refractory rheumatoid arthritis who have not responded adequately to prior therapies.

Who makes BMS-986528?

BMS-986528 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting a Phase 1 clinical trial of BMS-986528 in participants with refractory rheumatoid arthritis.

What phase is BMS-986528 in?

BMS-986528 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is currently recruiting participants with refractory rheumatoid arthritis.

What clinical trials is BMS-986528 in?

BMS-986528 is being evaluated in a Phase 1 clinical trial with the identifier NCT07412704, titled 'A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis'. This trial is currently recruiting and aims to enroll 84 participants across multiple countries including the United States, Belgium, Brazil, China, Germany, Italy, Mexico, Poland, Spain, Switzerland, and Ukraine.

Is BMS-986528 a small molecule?

Yes, BMS-986528 is a small molecule therapeutic. It is being developed as an oral or injectable treatment for rheumatoid arthritis, though the specific route of administration has not been disclosed in the available clinical trial information.