RecruitingRecruiting
A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis
NCT07412704 · Bristol-Myers Squibb
In plain English
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Official title
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
About this study
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 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.
Study design
Enrollment target: 84 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-09-15
Estimated completion: 2030-09-02
Last updated: 2026-08-24
Interventions
Drug: BMS-986528
Primary outcomes
- • 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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (39)
Local Institution - 0068Not Yet Recruiting
La Jolla, California, United States
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Loma Linda, California, United States
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Palo Alto, California, United States
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Aurora, Colorado, United States
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
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South Miami, Florida, United States
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New York, New York, United States
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New York, New York, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
Local Institution - 0051Withdrawn
DeSoto, Texas, United States
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Merksem, Flanders, Belgium
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Leuven, Belgium
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Aparecida de Goiânia, Goiás, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Valinhos, São Paulo, Brazil
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Zhengzhou, Henan, China
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Nanchang, Jiangxi, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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München, Bavaria, Germany
Charité Research OrganisationRecruiting
Berlin, Germany
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Cologne, Germany
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Herne, Germany
St. Josef-Stift SendenhorstRecruiting
Sendenhorst, Germany
Local Institution - 0019Not Yet Recruiting
Rozzano, Milano, Italy
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Roma, Italy
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México, Mexico
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Józefów, Masovian Voivodeship, Poland
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A Coruña, A Coruña [La Coruña], Spain
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Córdoba, Córdoba, Spain
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Bern, Switzerland
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Geneva, Switzerland
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Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Local Institution - 0064Not Yet Recruiting
Kyiv, Kyiv Oblast, Ukraine
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Poltava, Poltava Oblast, Ukraine
Local Institution - 0061Not Yet Recruiting
Ternopil, Ukraine