NCT07412704
Not yet recruiting
Phase 1
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
InterventionsBMS-986528
Overview
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 84
- Locations
- 31
- Primary Endpoint
- Number of participants with treatment-emergent adverse events (TEAEs)
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Cohort A1
Experimental
Intervention: BMS-986528 (Drug)
Cohort A2
Experimental
Intervention: BMS-986528 (Drug)
Cohort A3
Experimental
Intervention: BMS-986528 (Drug)
Cohort A4
Experimental
Intervention: BMS-986528 (Drug)
Cohort A5
Experimental
Intervention: BMS-986528 (Drug)
Cohort A6
Experimental
Intervention: BMS-986528 (Drug)
Cohort A7
Experimental
Intervention: BMS-986528 (Drug)
Cohort A8
Experimental
Intervention: BMS-986528 (Drug)
Cohort B1
Experimental
Intervention: BMS-986528 (Drug)
Cohort B2
Experimental
Intervention: BMS-986528 (Drug)
Outcomes
Primary Outcomes
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to Week 54
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to Week 54
Secondary Outcomes
- Apparent volume of distribution of terminal phase (Vz/F)(Up to Week 54)
- Change from baseline in numbers and fractions of B cells(Up to Week 54)
- Change from baseline in immunoglobulin G (igG) levels(Up to Week 54)
- Change from baseline in igM levels(Up to Week 54)
- Change from baseline in igE levels(Up to Week 54)
- Change from baseline in igD levels(Up to Week 54)
- Change from baseline in igA levels(Up to Week 54)
- Number of participants with anti-drug antibody (ADA)(Up to Week 54)
- Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)(At Week 12)
- area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to Week 54)
- Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))(Up to Week 54)
- Apparent terminal serum half-life (T-HALF)(Up to Week 54)
- Apparent total body clearance (CLT/F)(Up to Week 54)
- Maximum observed concentration (Cmax)(Up to Week 54)
- Time of maximum observed concentration (Tmax)(Up to Week 54)
Investigators
Study Sites (31)
Loading locations...
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