Title:

A Phase 1/2a, Open-Label Study of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

EUCT number:

2025-520666-22-00

Protocol code:

IM0620001

Table of Contents

1 Summary

1.1 Trial Information

Medical condition(s):

Refractory, difficult-to-treat Rheumatoid Arthritis

Trial Phase:

Phase I and Phase II (Integrated)- First administration to humans

Transition Trial:

No

Sponsor:

Bristol-Myers Squibb Services Unlimited Company

Participants type:

Patients

Age range:

18-64 years

Locations:

Spain, Poland, Italy, Germany

Main objective (English):

The main goal is to find out if BMS-986528 is safe for people with RA to take by looking at how many people have side effects after taking it

1.2 Overall Trial status

Overall trial status:

Authorised, recruiting

Start of Trial:

2026-07-31

End of trial:

Global end of trial:

Overall Trial Status:

Authorised, recruiting

Application Trial Status:

Member State Application Trial Status Decision Date
Spain Authorised, recruiting 2026-07-27
Poland Authorised, recruitment pending 2026-07-23
Italy Authorised, recruiting 2026-07-22
Germany Ongoing, recruiting 2026-07-22

1.3 Trial Notifications

1.3.1 Germany

Start of trial:

2026-07-31

Restart trial:

End of trial:

Early termination:

Reason for early termination:

1.3.2 Italy

Start of trial:

2026-09-30

Restart trial:

End of trial:

Early termination:

Reason for early termination:

1.3.3 Spain

Start of trial:

2026-09-15

Restart trial:

End of trial:

Early termination:

Reason for early termination:

1.4 Recruitment Notifications

1.4.1 Germany

Start of recruitment:

2026-10-06

Restart of recruitment:

End of recruitment:

1.4.2 Italy

Start of recruitment:

Restart of recruitment:

End of recruitment:

1.4.3 Spain

Start of recruitment:

Restart of recruitment:

End of recruitment:

1.5 Trial duration

Estimated recruitment start date in EU/EEA:

2026-07-26

Estimated end of trial date in EU/EEA:

2030-11-24

Estimated global end date of the trial:

2030-11-24

1.5.1 Source of monetary or financial support

Organisation name:

1.6 Serious Breaches

1.7 Unexpected Events

1.8 Urgent Safety Measures

1.9 Temporary Halts

1.10 Corrective Measures

1.11 Applications

1.11.1 IN

Application type:

INITIAL

Submission date:

2026-03-27

1.11.1.1 Assessment Part I

Reference Member State:

Germany

Final conclusion:

Acceptable

Conclusion reporting date:

2026-07-20

1.11.1.2 Assessment Part II

Member state Final conclusion Conclusion reporting date
Germany Acceptable 2026-07-10
Italy Acceptable 2026-07-06
Spain Acceptable 2026-07-10
Poland Acceptable 2026-07-13

1.11.1.3 Decision

Member state Decision Decision date Decision type
Poland Authorised
 2026-07-23
 Decision
Italy Authorised
 2026-07-22
 Decision
Spain Authorised
 2026-07-27
 Decision
Germany Authorised
 2026-07-22
 Decision

1.11.2 NSM-1

Application type:

NON SUBSTANTIAL MODIFICATION

Submission date:

2026-07-27

1.11.2.1 Assessment Part I

Reference Member State:

Germany

Final conclusion:

Acceptable

Conclusion reporting date:

2026-07-20

1.11.2.2 Assessment Part II

Member state Final conclusion Conclusion reporting date
Germany

1.11.2.3 Decision

Member state Decision Decision date Decision type
Germany Authorised
 2026-07-27
 Decision

1.11.3 NSM-2

Application type:

NON SUBSTANTIAL MODIFICATION

Submission date:

2026-07-27

1.11.3.1 Assessment Part I

Reference Member State:

Final conclusion:

Acceptable

Conclusion reporting date:

2026-07-20

1.11.3.2 Assessment Part II

Member state Final conclusion Conclusion reporting date
Spain

1.11.3.3 Decision

Member state Decision Decision date Decision type
Spain Authorised
 2026-07-27
 Decision

1.11.4 NSM-3

Application type:

NON SUBSTANTIAL MODIFICATION

Submission date:

2026-07-27

1.11.4.1 Assessment Part I

Reference Member State:

Final conclusion:

Acceptable

Conclusion reporting date:

2026-07-20

1.11.4.2 Assessment Part II

Member state Final conclusion Conclusion reporting date
Poland

1.11.4.3 Decision

Member state Decision Decision date Decision type
Poland Authorised
 2026-07-27
 Decision

1.11.5 SM-1

Application type:

SUBSTANTIAL MODIFICATION

Submission date:

2026-07-29

1.11.5.1 Assessment Part I

Reference Member State:

Final conclusion:

Acceptable

Conclusion reporting date:

1.11.5.2 Assessment Part II

Member state Final conclusion Conclusion reporting date
Italy Acceptable 2026-08-11

1.11.5.3 Decision

Member state Decision Decision date Decision type
Italy Authorised
 2026-08-25
 Decision

1.11.6 SM-2

Application type:

SUBSTANTIAL MODIFICATION

Submission date:

2026-09-24

1.11.6.1 Assessment Part I

Reference Member State:

Germany

Final conclusion:

Acceptable

Conclusion reporting date:

1.11.6.2 Assessment Part II

Member state Final conclusion Conclusion reporting date
Germany Acceptable 2026-10-20

1.11.6.3 Decision

Member state Decision Decision date Decision type
Germany Authorised
 2026-10-21
 Decision

2 Full trial information (Part I)

2.1 Trial details

2.1.1 Trial identifiers

2.1.1.1 Clinical trial identifiers

EU trial number:

2025-520666-22-00

Full title (English):

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

Public title (English):

A Phase 1/2a, Open-Label Study of BMS-986528 in Participants with Refractory Rheumatoid Arthritis

Protocol code:

IM0620001

2.1.1.2 Secondary identifying numbers

WHO universal trial number (UTN):

U1111-1317-6393

ClinicalTrials.gov identifier (NCT number):

NCT07412704

ISRCTN number:

2.1.1.3 Additional registries

2.1.2 Trial Information

2.1.2.1 Transition Trial

EudraCT number:

2.1.2.2 Trial Category

Trial phase:

Phase I and Phase II (Integrated)- First administration to humans

Trial category:

2

Justification for trial category:

Is a phase 1/2a trial

2.1.2.3 Medical Conditions

Medical condition(s) (English):

Refractory, difficult-to-treat Rheumatoid Arthritis

Is the medical condition considered to be a rare disease:

No

Therapeutic area:

Diseases [C] - Immune System Diseases [C20]

2.1.2.4 Medical condition(s) MedDRA information

Version Level Classification code Term name System organ class
23.1 PT 10039073 Rheumatoid arthritis 100000004859

2.1.2.5 Main objective

Trial scope:

Other, Efficacy, Pharmacodynamic, Pharmacokinetic, Safety

Main objective (English):

The main goal is to find out if BMS-986528 is safe for people with RA to take by looking at how many people have side effects after taking it

2.1.2.6 Secondary objective

Secondary objective number Secondary objective (English)
1 How BMS-986528 moves in the body (Pharmacokinetics, PK): How BMS-986528 travels through the blood after it is given as an injection under the skin
2 Effect on Certain Blood Cells (Pharmacodynamics, PD): Check if BMS-986528 changes the number of B cells in the blood.
3 Effect on Immune Proteins: See if BMS-986528 changes the levels of special proteins in the blood called immunoglobulins, which are also called antibodies.
4 Body’s Reaction to BMS-986528 (Immunogenicity): See if people’s bodies make immunoglobulins or antibodies against BMS-986528
5 Does BMS-986528 Help with disease symptoms? (Disease-Modifying Effect): For one part of the study, the researchers will check if BMS-986528 helps improve symptoms of RA, like joint pain and swelling, and how people with RA feel and function

2.1.2.7 Principal inclusion criteria

Inclusion criteria number Principal inclusion criteria (English)
1 adults, 18 to 65 years of age
2 adults who meet the medical definition of difficult-to-treat RA per international standards for defining RA and have had the disease for more than 2 years

2.1.2.8 Principal exclusion criteria

Exclusion criteria number Principal exclusion criteria (English)
1 juvenile arthritis or onset of inflammatory arthritis before age 18
2 a form of RA called seronegative RA if it is unclear whether the patient truly has RA
3 symptoms that would interfere with accurate joint assessments during the study, such as fibromyalgia

2.1.2.9 Primary end points

End point criteria number Primary end point (English)
1 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

2.1.2.10 Secondary end points

Secondary end point number Secondary end point (English)
1 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
2 Measure if BMS-986528 changes the number and types of B cells in the blood
3 Measure changes in the levels of proteins called immunoglobulins in the blood
4 Measure if people’s bodies make antibodies against BMS-986528
5 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

2.1.2.11 Individual Participant Data (IPD) Sharing statement

Plan to share IPD:

Yes

Plan description:

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

2.1.2.12 Participants

Gender:

Male and Female

Age range:

18-64 years

Age range secondary identifier:

Clinical trial group:

Patients

Vulnerable population:

No

2.1.3 Protocol information

2.1.3.1 Study design

Period details:

Number Period title Period description Allocation method Blinding used Roles blinded Blinding implementation details Arm details

2.1.4 Scientific advice and paediatric investigation plan (PIP)

Competent authorities that have provided scientific advice:

Food And Drug Administration

EMA paediatric investigation number:

2.1.5 Associated clinical trials

Associated EU CTA number Full title Sponsor for associated clinical trial

2.1.7 References

Reference to publication:

Reference link to publication:

2.2 Products

2.2.1 Role: Test Name: BMS-986528

2.2.1.1 Product: BMS-986528

Type

Product

Excluded MSCs

2.2.1.1.1 Product details

Medicinal product name:

BMS-986528

EU medicinal product number/medicinal product unique ID:

PRD13473105

Pharmaceutical form:

SOLUTION FOR INJECTION

Strength:

Medicinal product other name:

Is this a specific paediatric formulation:

No

Product authorisation status:

Not Authorised

Medicinal product role in trial:

Test

Sponsors product code:

BMS-986528

2.2.1.1.2 Products characteristics

Medicinal product characteristics:

Recombinant

Other medicinal product:

2.2.1.1.3 Dosage and administration Details

Route of administration:

SUBCUTANEOUS INJECTION

Maximum duration of treatment:

undefined undefined

Maximum daily dose allowed:

Daily dose unit of measure:

Maximum total dose allowed:

Total dose unit of measure:

2.2.1.1.4 Information about the modification of the medicinal product

Has the medicinal product been modified in relation to its Marketing Authorisation:

No

Description of the modification:

2.2.1.1.5 Product classification

Anatomical Therapeutic Chemical (ATC) Codes:

ATC name:

ATC level:

2.2.1.1.6 Product authorisation details

MA holder

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION

MA authorisation country

Marketing authorisation number

Centralised procedure/MRP/DCP/registration procedure number

2.2.1.1.7 Orphan designation

Does this product have an orphan drug designation:

No

Designation number for orphan drug:

2.2.1.1.8 Active substance

Classification:

Protein - Other

Active Substance name:

BI 3821001

Active substance name synonyms:

Active Substance other descriptive name:

EU Active Substance Code:

SUB439333

Strength:

Status:

Not Authorised

2.2.1.1.9 Advanced therapy medicinal product
2.2.1.1.10 Device associated with medicinal product
Product used in combination with a device Product ID Device trade name Description of the device Type of device Device has CE mark Device notified body

2.2.1.1 Compliance with (GMP) for the medicinal product

Authorisation number of manufacturing and import:

IMP13128/00001

2.2.2 Role: Auxiliary Name: TOCILIZUMAB

2.2.2.1 Product: TOCILIZUMAB

Type

Substance

Excluded MSCs

2.2.2.1.1 Product details

Medicinal product name:

TOCILIZUMAB

EU medicinal product number/medicinal product unique ID:

SUB20313

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Strength:

Medicinal product other name:

Is this a specific paediatric formulation:

No

Product authorisation status:

Authorised

Medicinal product role in trial:

Auxiliary

Sponsors product code:

2.2.2.1.2 Products characteristics

Medicinal product characteristics:

Recombinant

Other medicinal product:

2.2.2.1.3 Dosage and administration Details

Route of administration:

INTRAVENOUS

Maximum duration of treatment:

undefined undefined

Maximum daily dose allowed:

Daily dose unit of measure:

Maximum total dose allowed:

Total dose unit of measure:

2.2.2.1.4 Information about the modification of the medicinal product

Has the medicinal product been modified in relation to its Marketing Authorisation:

Yes

Description of the modification:

removed from the carton, over-labeled, and repackaged

2.2.2.1.5 Product classification

Anatomical Therapeutic Chemical (ATC) Codes:

-

ATC name:

-

ATC level:

-

2.2.2.1.6 Product authorisation details

MA holder

MA authorisation country

Marketing authorisation number

-

Centralised procedure/MRP/DCP/registration procedure number

2.2.2.1.7 Orphan designation

Does this product have an orphan drug designation:

No

Designation number for orphan drug:

2.2.2.1.8 Active substance

Classification:

-

Active Substance name:

TOCILIZUMAB

Active substance name synonyms:

Active Substance other descriptive name:

EU Active Substance Code:

SUB20313

Strength:

Status:

Authorised

2.2.2.1.9 Advanced therapy medicinal product
2.2.2.1.10 Device associated with medicinal product
Product used in combination with a device Product ID Device trade name Description of the device Type of device Device has CE mark Device notified body

2.2.2.1 Compliance with (GMP) for the medicinal product

Authorisation number of manufacturing and import:

3 Trial Results

3.1 Summaries of Results

3.2 Layperson Summaries of Results

3.3 Clinical Study Reports

4 Locations and contact points

4.1 Locations

4.1.1 Spain - Authorised, recruiting

Planned number of subjects:

3

4.1.1.1 Site: Hospital Universitario Reina Sofia

OMS ID:

ORG-100041195

Department name:

Rheumatology

Site location:

Avenida Menendez Pidal S/n

Site street address:

Avenida Menendez Pidal S/n

Site city:

Cordoba

Site post code:

14004

Site country:

Spain

First name:

Alejandro

Last name:

Escudero

Title:

Dr.

Telephone number:

957011631

Email:

XXXXX@XXX.com

4.1.1.2 Site: Complexo Hospitalario Universitario A Coruna

OMS ID:

ORG-100041242

Department name:

Rheumatology

Site location:

Lugar Jubias De Arriba 84

Site street address:

Lugar Jubias De Arriba 84

Site city:

A Coruna

Site post code:

15006

Site country:

Spain

First name:

Francisco Javier

Last name:

Blanco Garcia

Title:

Dr.

Telephone number:

981176399

Email:

fblagar@sergas.es

4.1.2 Poland - Authorised, recruitment pending

Planned number of subjects:

4

4.1.2.1 Site: Biokinetica S.A.

OMS ID:

ORG-100044263

Department name:

Przychodnia Józefów

Site location:

Ul. Nadwislanska 37

Site street address:

Ul. Nadwislanska 37

Site city:

Jozefow

Site post code:

05-410

Site country:

Poland

First name:

Monika

Last name:

Tomaszewska-Kiecana

Title:

Dr.

Telephone number:

221881440

Email:

office@biokinetica.com

4.1.3 Italy - Authorised, recruiting

Planned number of subjects:

2

4.1.3.1 Site: Humanitas Mirasole S.p.A.

OMS ID:

ORG-100007492

Department name:

Division of Rheumatology and Clinical Immunology

Site location:

Via Alessandro Manzoni 56

Site street address:

Via Alessandro Manzoni 56

Site city:

Rozzano

Site post code:

20089

Site country:

Italy

First name:

Elisa

Last name:

Gremese

Title:

Prof.

Telephone number:

00390282247421

Email:

elisa.gremese@hunimed.eu

4.1.3.2 Site: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OMS ID:

ORG-100014358

Department name:

U.O.C. Rheumatology

Site location:

Largo Francesco Vito 1

Site street address:

Largo Francesco Vito 1

Site city:

Rome

Site post code:

00168

Site country:

Italy

First name:

Maria Antonietta

Last name:

D'Agostino

Title:

Prof.

Telephone number:

00390630157803

Email:

mariaantonietta.dagostino@policlinicogemelli.it

4.1.4 Germany - Ongoing, recruiting

Planned number of subjects:

12

4.1.4.1 Site: St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr

OMS ID:

ORG-100010413

Department name:

Rheumazentrum Ruhrgebiet

Site location:

Claudiusstrasse 45, Wanne

Site street address:

Claudiusstrasse 45

Site city:

Herne

Site post code:

44649

Site country:

Germany

First name:

Xenofon

Last name:

Baraliakos

Title:

Prof.

Telephone number:

+492325592709

Email:

xenofon.baraliakos@elisabethgruppe.de

4.1.4.2 Site: Charite Research Organisation GmbH

OMS ID:

ORG-100028160

Department name:

Charité Research Organisation

Site location:

Chariteplatz 1, Mitte

Site street address:

Chariteplatz 1

Site city:

Berlin

Site post code:

10117

Site country:

Germany

First name:

Stanislav

Last name:

Ignatenko

Title:

Prof.

Telephone number:

030450539200

Email:

stanislav.ignatenko@charite-research.org

4.1.4.3 Site: LMU Klinikum Muenchen AöR

OMS ID:

ORG-100008479

Department name:

Medizinische Klinik und Poliklinik IV, Rheumazentrum

Site location:

Pettenkoferstrasse 8a, Ludwigsvorstadt-Isarvorstadt

Site street address:

Pettenkoferstrasse 8a

Site city:

Munich

Site post code:

80336

Site country:

Germany

First name:

Hendrik

Last name:

Schulze-Koops

Title:

Prof.

Telephone number:

089440053579

Email:

hendrik.schulze-koops@med.uni-muenchen.de

4.1.4.4 Site: Universitaetsklinikum Koeln AöR

OMS ID:

ORG-100012761

Department name:

Klinik I für Innere Medizin, Immunologie & Rheumatologie

Site location:

Kerpener Strasse 62, Lindenthal

Site street address:

Kerpener Strasse 62

Site city:

Cologne

Site post code:

50937

Site country:

Germany

First name:

Philipp

Last name:

Koehler

Title:

Dr.

Telephone number:

022147884774

Email:

philipp.koehler@uk-koeln.de

4.1.4.5 Site: St. Josef Stift GmbH

OMS ID:

ORG-100025838

Department name:

Klinik für Rheumatologie und Klinische Immunologie

Site location:

Westtor 7

Site street address:

Westtor 7

Site city:

Sendenhorst

Site post code:

48324

Site country:

Germany

First name:

Peter

Last name:

Korsten

Title:

Dr.

Telephone number:

05513913065117

Email:

p.korsten@st-josef-stift.de

4.1.5 Countries outside of the European Economic Area

Countries outside of the European Economic Area:

United States, Mexico, Ukraine, China, Brazil, Switzerland

Participants in the rest of the world:

51

4.2 Sponsors

4.2.1 Sponsor:

Bristol-Myers Squibb Services Unlimited Company

4.2.1.1 Sponsor details

ID:

ORG-100045833

Name of sponsor organisation:

Bristol-Myers Squibb Services Unlimited Company

Address:

Plaza 254, Blanchardstown Corporate Park 2

Town/City:

Dublin 15

Post code:

D15 T867

Country:

Ireland

Phone:

Email address:

4.2.1.2 Scientific contact point

Name of organisation:

Bristol-Myers Squibb Services Unlimited Company

Functional contact point name:

mg gsm ct

Phone:

+35314833615

Email address:

mg-gsm-ct@bms.com

4.2.1.3 Public contact point

Name of organisation:

Bristol-Myers Squibb Services Unlimited Company

Functional contact point name:

mg gsm ct

Phone:

+35314833615

Email address:

mg-gsm-ct@bms.com

4.2.1.4 Third parties associated with the trial

ID Organisation Name Address City Postcode Country Phone Email Duties
ORG-100008382 Syneos Health Inc. 1030 Sync Street Morrisville 27560-5468 United States 1111 xxxx@xxxx.com On site monitoring, Statistical analysis, Medical writing, Regulatory expertise, Other, Investigator recruitment, Data management, Q/A auditing
ORG-100011524 Labcorp Central Laboratory Services SARL Rue Moise-Marcinhes 7 Meyrin 1217 Switzerland 1111 xxx@xxxx.com Other, Laboratory analysis
ORL-000012879 Endpoint Clinical Inc. 701 Edgewater Drive Suite 320 Wakefield 1880 United States 1111 xxxx@xxxx.com Other
ORG-100051510 Mural Health Technologies Inc. 1189 Lancaster Avenue Berwyn 19312-1299 United States 1111 xxx@xxxx.com Other
ORG-100012847 QPS LLC 3 Innovation Way Suite 204 Newark 19711-5456 United States 1111 xxx@xxxx.com Other

4.2.2 Responsibilities of the sponsor

Sponsor(s) responsible for compliance:

Sponsor(s) responsible for being a contact point:

Sponsor(s) responsible for implementing the measures taken in accordance with article 77: