NCT07412704

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).

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
47mo left

Started Sep 2026

Longer than P75 for phase_1

Geographic Reach
11 countries

39 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Sep 2030

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2029

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2030

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

February 9, 2026

Last Update Submit

September 21, 2026

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (15)

  • Maximum observed concentration (Cmax)

    Up to Week 54

  • Time of maximum observed concentration (Tmax)

    Up to Week 54

  • 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

  • +10 more secondary outcomes

Study Arms (10)

Cohort A1

EXPERIMENTAL
Drug: BMS-986528

Cohort A2

EXPERIMENTAL
Drug: BMS-986528

Cohort A3

EXPERIMENTAL
Drug: BMS-986528

Cohort A4

EXPERIMENTAL
Drug: BMS-986528

Cohort A5

EXPERIMENTAL
Drug: BMS-986528

Cohort A6

EXPERIMENTAL
Drug: BMS-986528

Cohort A7

EXPERIMENTAL
Drug: BMS-986528

Cohort A8

EXPERIMENTAL
Drug: BMS-986528

Cohort B1

EXPERIMENTAL
Drug: BMS-986528

Cohort B2

EXPERIMENTAL
Drug: BMS-986528

Interventions

BMS-986528DRUG

Specified dose on specified days

Cohort A1Cohort A2Cohort A3Cohort A4Cohort A5Cohort A6Cohort A7Cohort A8Cohort B1Cohort B2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Local Institution - 0068

La Jolla, California, 92037, United States

NOT YET RECRUITING

Local Institution - 0070

Loma Linda, California, 92354, United States

NOT YET RECRUITING

Local Institution - 0069

Palo Alto, California, 94304-2210, United States

NOT YET RECRUITING

Local Institution - 0050

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Local Institution - 0055

South Miami, Florida, 33143, United States

NOT YET RECRUITING

Local Institution - 0081

New York, New York, 10016, United States

NOT YET RECRUITING

Local Institution - 0079

New York, New York, 10029, United States

NOT YET RECRUITING

Local Institution - 0066

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Local Institution - 0071

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Local Institution - 0051

DeSoto, Texas, 75115, United States

WITHDRAWN

Local Institution - 0048

Merksem, Flanders, 2170, Belgium

NOT YET RECRUITING

Local Institution - 0049

Leuven, 3000, Belgium

NOT YET RECRUITING

Local Institution - 0083

Aparecida de Goiânia, Goiás, 74935-530, Brazil

NOT YET RECRUITING

Local Institution - 0033

Porto Alegre, Rio Grande do Sul, 90050-010, Brazil

NOT YET RECRUITING

Local Institution - 0082

Valinhos, São Paulo, 13271-130, Brazil

NOT YET RECRUITING

Local Institution - 0006

Beijing, Beijing Municipality, 100091, China

NOT YET RECRUITING

Local Institution - 0080

Guangzhou, Guangdong, 510260, China

NOT YET RECRUITING

Local Institution - 0010

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

Local Institution - 0007

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

Local Institution - 0020

Shanghai, Shanghai Municipality, 200040, China

NOT YET RECRUITING

Local Institution - 0001

Shanghai, Shanghai Municipality, 200127, China

NOT YET RECRUITING

Local Institution - 0040

München, Bavaria, 81377, Germany

NOT YET RECRUITING

Charité Research Organisation

Berlin, 10117, Germany

RECRUITING

Local Institution - 0021

Cologne, 50937, Germany

NOT YET RECRUITING

Local Institution - 0028

Herne, 44652, Germany

NOT YET RECRUITING

St. Josef-Stift Sendenhorst

Sendenhorst, 48324, Germany

RECRUITING

Local Institution - 0019

Rozzano, Milano, 20089, Italy

NOT YET RECRUITING

Local Institution - 0017

Roma, 00168, Italy

NOT YET RECRUITING

Local Institution - 0053

México, 14080, Mexico

NOT YET RECRUITING

Local Institution - 0023

Józefów, Masovian Voivodeship, 05-410, Poland

NOT YET RECRUITING

CHUAC-Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña [La Coruña], 15006, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Universitaetsspital Bern - Inselspital

Bern, 3010, Switzerland

RECRUITING

Local Institution - 0027

Geneva, 1211, Switzerland

NOT YET RECRUITING

Local Institution - 0060

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine

NOT YET RECRUITING

Local Institution - 0063

Poltava, Poltava Oblast, 36011, Ukraine

NOT YET RECRUITING

Local Institution - 0064

Kyiv, 01135, Ukraine

NOT YET RECRUITING

Local Institution - 0061

Ternopil, 46002, Ukraine

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

September 2, 2030

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

CN(6)BE(2)UA(4)IT(2)PL(1)US(11)DE(5)ES(2)CH(2)BR(3)ME(1)