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Not yet recruiting NCT07412704

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

Phase I / Phase II Interventional Arthritis, Rheumatoid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986528.
Who it may be relevant to
Registry conditions: Arthritis, Rheumatoid. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Brazil, China, Germany +7
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Drug BMS-986528
    Specified dose on specified days

Primary outcome measures

  • 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 outcome measures (12)
  • Maximum observed concentration (Cmax) [Time frame: Up to Week 54]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to Week 54]
  • area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Time frame: Up to Week 54]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Time frame: Up to Week 54]
  • Apparent terminal serum half-life (T-HALF) [Time frame: Up to Week 54]
  • Apparent total body clearance (CLT/F) [Time frame: Up to Week 54]
  • Apparent volume of distribution of terminal phase (Vz/F) [Time frame: Up to Week 54]
  • Change from baseline in numbers and fractions of B cells [Time frame: Up to Week 54]
  • Change from baseline in immunoglobulin G (igG) levels [Time frame: Up to Week 54]
  • Change from baseline in igM levels [Time frame: Up to Week 54]
  • Change from baseline in igE levels [Time frame: Up to Week 54]
  • Change from baseline in igD levels [Time frame: Up to Week 54]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 12 centers
  • Local Institution - 0068 — La Jolla
  • Local Institution - 0070 — Loma Linda
  • Local Institution - 0069 — Palo Alto
  • Local Institution - 0050 — Aurora
  • Local Institution - 0067 — Denver
  • Local Institution - 0055 — South Miami
  • Local Institution - 0081 — New York
  • Local Institution - 0079 — New York
  • … and 4 more centers
China · 6 centers
  • Local Institution - 0006 — Beijing
  • Local Institution - 0080 — Guangzhou
  • Local Institution - 0010 — Zhengzhou
  • Local Institution - 0007 — Nanchang
  • Local Institution - 0020 — Shanghai
  • Local Institution - 0001 — Shanghai
Germany · 6 centers
  • Local Institution - 0040 — München
  • Local Institution - 0022 — Berlin
  • Local Institution - 0021 — Cologne
  • Local Institution - 0028 — Herne
  • Local Institution - 0065 — Potsdam
  • Local Institution - 0056 — Sendenhorst
Ukraine · 5 centers
  • Local Institution - 0060 — Ivano-Frankivsk
  • Local Institution - 0064 — Kyiv
  • Local Institution - 0063 — Poltava
  • Local Institution - 0062 — Kyiv
  • Local Institution - 0061 — Ternopil
Brazil · 3 centers
  • Local Institution - 0083 — Aparecida de Goiânia
  • Local Institution - 0033 — Porto Alegre
  • Local Institution - 0082 — Valinhos
Belgium · 2 centers
  • Local Institution - 0048 — Merksem
  • Local Institution - 0049 — Leuven
Italy · 2 centers
  • Local Institution - 0019 — Rozzano
  • Local Institution - 0017 — Roma
Spain · 2 centers
  • Local Institution - 0039 — A Coruña
  • Local Institution - 0058 — Córdoba
Switzerland · 2 centers
  • Local Institution - 0037 — Bern
  • Local Institution - 0027 — Geneva
Hungary · 1 center
  • Local Institution - 0045 — Budapest
Mexico · 1 center
  • Local Institution - 0053 — México
Poland · 1 center
  • Local Institution - 0023 — Józefów

Identifiers

NCT: NCT07412704 · IM062-0001 · 2025-520666-22 · U1111-1317-6393

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗