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

Bristol-Myers Squibb

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).

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

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.

Interventions

Drug
BMS-986528
Specified dose on specified days

Locations (31)

Local Institution - 0050
Aurora, Colorado
Local Institution - 0055
South Miami, Florida
Local Institution - 0066
Portland, Oregon
Local Institution - 0051
DeSoto, Texas
Local Institution - 0057
San Antonio, Texas
Local Institution - 0048
Merksem, Flanders