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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

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520666-22-00
Enrollment
18
Registered
2026-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

difficult-to-treat Rheumatoid Arthritis, Refractory

Brief summary

The main goal of this study is to find out if BMS-986528 is safe for people with RA by counting how many people have mild and serious side effects after taking BMS-986528

Detailed description

Measure how much BMS-986528 is in the blood at different times after it is given and look at things like the highest amount of BMS-986528 in the blood, how long it takes to reach that amount, and how quickly the body gets rid of it, Measure if BMS-986528 changes the number and types of B cells in the blood, Measure changes in the levels of proteins called immunoglobulins in the blood, Measure if people’s bodies make antibodies against BMS-986528, Check if BMS-986528 helps reduce the symptoms of RA after about 3 months using a score called DAS28-CRP, which measures how much pain and swelling a patient has as well as how much inflammation is in the body and how a patient feels

Interventions

DRUGTOCILIZUMAB

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The main goal of this study is to find out if BMS-986528 is safe for people with RA by counting how many people have mild and serious side effects after taking BMS-986528

Secondary

MeasureTime frame
Measure how much BMS-986528 is in the blood at different times after it is given and look at things like the highest amount of BMS-986528 in the blood, how long it takes to reach that amount, and how quickly the body gets rid of it, Measure if BMS-986528 changes the number and types of B cells in the blood, Measure changes in the levels of proteins called immunoglobulins in the blood, Measure if people’s bodies make antibodies against BMS-986528, Check if BMS-986528 helps reduce the symptoms of RA after about 3 months using a score called DAS28-CRP, which measures how much pain and swelling a patient has as well as how much inflammation is in the body and how a patient feels

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 24, 2026