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BMS-986528

Phase 1

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Bristol-Myers Squibb Company|Last Updated: Feb 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07412704A Study of BMS-986528 in Participants With Refractory Rheumatoid ArthritisPHASE1 NOT YET_RECRUITING 84 — — May 28, 2026Sep 2, 2030Feb 23, 202631 United States, Belgium +8
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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 — 65 Years
SexALL
Healthy VolunteersNo
Study Sites31

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 StatesBelgiumChinaGermanyHungaryItalyPolandSpainSwitzerlandUkraine
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07412704primaryCompletionDate: changed
LOWMay 24, 2026NCT07412704studyFirstPostDate: changed