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NCT07412704

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

StatusRecruiting
PhasePhase 1/2
Primary completion (estimated)
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date changed from estimate of Sep 15, 2026 to Oct 6, 2026
    • Study sites revised (39)
  2. Secondary endpoints: details revised at 2 of 15 entries
    • Study sites revised (39)
    • Eligibility criteria expanded, about 4 words
  3. Recruitment opened
    • Trial sites reduced: 43 → 39 locations
    v4
  4. Start date: May 28, 2026 to Sep 15, 2026
    • Trial sites expanded: 31 → 43 locations
    v3
  5. Site contacts updated at 1 of 31 sitesv2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (15)

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

Arms and interventions

Cohort A1Experimental
Cohort A2Experimental
Cohort A3Experimental
Cohort A4Experimental
Cohort A5Experimental
Cohort A6Experimental
Cohort A7Experimental
Cohort A8Experimental
Cohort B1Experimental
Cohort B2Experimental

Drugs: BMS-986528

Sites

39 sites in 11 countries

United States 11, China 6, Germany 5, Ukraine 4, Brazil 3, Belgium 2, Italy 2, Spain 2, Switzerland 2, Mexico 1, Poland 1