Arthritis, RheumatoidPhase 1/2NCT07412704

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

A Phase 1/2 study testing BMS-986528 in people with Arthritis, Rheumatoid, run by Bristol-Myers Squibb at 39 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Arthritis, Rheumatoid
What is being tested?: BMS-986528
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 39 sitesin 11 countries
Study dates: 6 Oct 2026to 2 Sep 2030
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

39 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

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

Country

City, postcode or hospital

Sites recruiting now only

39 sites in 11 countries

United States11 sites, 10 recruiting

Local Institution - 0050
Aurora, Colorado, 80045
Site 0050
Not yet recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Richard Nash, Site 0067, 303-981-2305
Recruiting
Local Institution - 0051
DeSoto, Texas, 75115
Withdrawn
Local Institution - 0068
La Jolla, California, 92037
Site 0068
Not yet recruiting
Local Institution - 0070
Loma Linda, California, 92354
Site 0070
Not yet recruiting
Local Institution - 0081
New York, New York, 10016
Site 0081
Not yet recruiting
Local Institution - 0079
New York, New York, 10029
Site 0079
Not yet recruiting
Local Institution - 0069
Palo Alto, California, 94304-2210
Site 0069
Not yet recruiting
Local Institution - 0071
Philadelphia, Pennsylvania, 19107
Site 0071
Not yet recruiting
Local Institution - 0066
Portland, Oregon, 97239
Site 0066
Not yet recruiting
Local Institution - 0055
South Miami, Florida, 33143
Site 0055
Not yet recruiting

Other trials in United States

China6 sites, 6 recruiting

Local Institution - 0006
Beijing, Beijing Municipality, 100091
Site 0006
Not yet recruiting
Local Institution - 0080
Guangzhou, Guangdong, 510260
Site 0080
Not yet recruiting
Local Institution - 0007
Nanchang, Jiangxi, 330006
Site 0007
Not yet recruiting
Local Institution - 0020
Shanghai, Shanghai Municipality, 200040
Site 0020
Not yet recruiting
Local Institution - 0001
Shanghai, Shanghai Municipality, 200127
Site 0001
Not yet recruiting
Local Institution - 0010
Zhengzhou, Henan, 450000
Site 0010
Not yet recruiting

Other trials in China

Germany5 sites, 5 recruiting

Charité Research Organisation
Berlin, 10117
Stanislav Ignatenko, Site 0022, 4930450539200
Recruiting
Local Institution - 0021
Cologne, 50937
Site 0021
Not yet recruiting
Rheumazentrum Ruhrgebiet
Herne, 44649
Ioana Andreica, Site 0028
Recruiting
Local Institution - 0040
München, Bavaria, 81377
Site 0040
Not yet recruiting
St. Josef-Stift Sendenhorst
Sendenhorst, 48324
Peter Korsten, Site 0056, +495513913065117
Recruiting

Other trials in Germany

Ukraine4 sites, 4 recruiting

Local Institution - 0060
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008
Site 0060
Not yet recruiting
Local Institution - 0064
Kyiv, 01135
Site 0064
Not yet recruiting
Local Institution - 0063
Poltava, Poltava Oblast, 36011
Site 0063
Not yet recruiting
Local Institution - 0061
Ternopil, 46002
Site 0061
Not yet recruiting

Other trials in Ukraine

Brazil3 sites, 3 recruiting

Local Institution - 0083
Aparecida de Goiânia, Goiás, 74935-530
Site 0083
Not yet recruiting
Local Institution - 0033
Porto Alegre, Rio Grande do Sul, 90050-010
Site 0033
Not yet recruiting
Local Institution - 0082
Valinhos, São Paulo, 13271-130
Site 0082
Not yet recruiting

Other trials in Brazil

Belgium2 sites, 2 recruiting

Local Institution - 0049
Leuven, 3000
Site 0049
Not yet recruiting
Local Institution - 0048
Merksem, Flanders, 2170
Site 0048
Not yet recruiting

Other trials in Belgium

Italy2 sites, 2 recruiting

Fondazione Policlinico Gemelli IRCCS
Roma, 00168
MARIA ANTONIETTA D'AGOSTINO, Site 0017, +393495458711
Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Elisa Gremese, Site 0019, +393271418439
Recruiting

Other trials in Italy

Spain2 sites, 2 recruiting

CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006
Francisco Javier Blanco Garcia, Site 0039, 981176399
Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
ALEJANDRO ESCUDERO, Site 0058, 957011631
Recruiting

Other trials in Spain

Switzerland2 sites, 2 recruiting

Universitaetsspital Bern - Inselspital
Bern, 3010
Burkhard Moeller, Site 0037, 0000000000
Recruiting
Hôpitaux Universitaire de Genève
Geneva, 1211
Kim Lauper, Site 0027, +41 (0)22 372 36 78
Recruiting

Other trials in Switzerland

Mexico1 site, 1 recruiting

Local Institution - 0053
México, 14080
Site 0053
Not yet recruiting

Other trials in Mexico

Poland1 site, 1 recruiting

Local Institution - 0023
Józefów, Masovian Voivodeship, 05-410
Site 0023
Not yet recruiting

Other trials in Poland

About this study

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

Conditions: Arthritis, Rheumatoid
Being tested: BMS-986528
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986528Drug
Specified dose on specified days

Study groups in NCT07412704
Study group	Role	What they receive
Cohort A1	Experimental	Not described Receives: Drug: BMS-986528
Cohort A2	Experimental	Not described Receives: Drug: BMS-986528
Cohort A3	Experimental	Not described Receives: Drug: BMS-986528
Cohort A4	Experimental	Not described Receives: Drug: BMS-986528
Cohort A5	Experimental	Not described Receives: Drug: BMS-986528
Cohort A6	Experimental	Not described Receives: Drug: BMS-986528
Cohort A7	Experimental	Not described Receives: Drug: BMS-986528
Cohort A8	Experimental	Not described Receives: Drug: BMS-986528
Cohort B1	Experimental	Not described Receives: Drug: BMS-986528
Cohort B2	Experimental	Not described Receives: Drug: BMS-986528

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to Week 54
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to Week 54

Secondary outcomes (15)

Maximum observed concentration (Cmax)
Measured: Up to Week 54
Time of maximum observed concentration (Tmax)
Measured: Up to Week 54
area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Week 54
Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Week 54
Apparent terminal serum half-life (T-HALF)
Measured: Up to Week 54
Apparent total body clearance (CLT/F)
Measured: Up to Week 54
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Up to Week 54
Change from baseline in numbers and fractions of B cells
Measured: Up to Week 54
Change from baseline in immunoglobulin G (igG) levels
Measured: Up to Week 54
Change from baseline in igM levels
Measured: Up to Week 54
Change from baseline in igE levels
Measured: Up to Week 54
Change from baseline in igD levels
Measured: Up to Week 54
Change from baseline in igA levels
Measured: Up to Week 54
Number of participants with anti-drug antibody (ADA)
Measured: Up to Week 54
Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)
Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 20262 Sep 2030

First posted17 Feb 2026
Study start6 Oct 2026
Primary completion30 Oct 2029 (estimated)
Study completion2 Sep 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07412704
Sponsor's protocol ID: IM062-0001
Other IDs: 2025-520666-22, U1111-1317-6393, 2025
Status last verified: Oct 2026
First submitted: 9 Feb 2026
Last updated: 23 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Pain Phenotyping of Rheumatic Diseases - An Observational Study
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Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis
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