1.3.1 Germany
Start of trial:
2026-07-31
Restart trial:
End of trial:
Early termination:
Reason for early termination:
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:
Germany, Spain, Poland, Italy
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 |
|---|---|---|
| Germany | Authorised, recruiting | 2026-07-22 |
| Spain | Authorised, recruitment pending | 2026-07-27 |
| Poland | Authorised, recruitment pending | 2026-07-23 |
| Italy | Authorised, recruitment pending | 2026-07-22 |
1.3 Trial Notifications
1.4 Recruitment Notifications
1.4.1 Germany
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:
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 |
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:
Pharmacokinetic, Pharmacodynamic, Other, Efficacy, 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: Auxiliary Name: TOCILIZUMAB
2.2.1.1 Product: TOCILIZUMAB
Type
Substance
Excluded MSCs
2.2.1.1.1 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:
2.2.1.1.2 Products characteristics
Medicinal product characteristics:
Recombinant
Other medicinal product:
2.2.1.1.3 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:
2.2.1.1.4 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
2.2.1.1.5 Product classification
Anatomical Therapeutic Chemical (ATC) Codes:
-
ATC name:
-
ATC level:
-
2.2.1.1.6 Product authorisation details
MA holder
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:
-
Active Substance name:
TOCILIZUMAB
Active substance name synonyms:
Active Substance other descriptive name:
EU Active Substance Code:
SUB20313
Strength:
Status:
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:
2.2.2 Role: Test Name: BMS-986528
2.2.2.1 Product: BMS-986528
Type
Product
Excluded MSCs
2.2.2.1.1 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
2.2.2.1.2 Products characteristics
Medicinal product characteristics:
Recombinant
Other medicinal product:
2.2.2.1.3 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:
2.2.2.1.4 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:
2.2.2.1.5 Product classification
Anatomical Therapeutic Chemical (ATC) Codes:
ATC name:
ATC level:
2.2.2.1.6 Product authorisation details
MA holder
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
MA authorisation country
Marketing authorisation number
Centralised procedure/MRP/DCP/registration procedure number
2.2.2.1.7 Orphan designation
Does this product have an orphan drug designation:
No
Designation number for orphan drug:
2.2.2.1.8 Active substance
Classification:
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
2.2.2.1.9 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:
IMP13128/00001
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 Germany - Authorised, recruiting
Planned number of subjects:
12
4.1.1.1 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
4.1.1.2 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
4.1.1.3 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:
Ioana
Last name:
Andreica
Title:
Dr.
Telephone number:
02325592707
Email:
ioana.andreica@elisabethgruppe.de
4.1.1.4 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
4.1.1.5 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
4.1.2 Spain - Authorised, recruitment pending
Planned number of subjects:
3
4.1.2.1 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
4.1.2.2 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
4.1.3 Poland - Authorised, recruitment pending
Planned number of subjects:
4
4.1.3.1 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
4.1.4 Italy - Authorised, recruitment pending
Planned number of subjects:
2
4.1.4.1 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
4.1.4.2 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
4.1.5 Countries outside of the European Economic Area
Countries outside of the European Economic Area:
Switzerland, Ukraine, United States, Mexico, Brazil, China
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 | Duties | |
|---|---|---|---|---|---|---|---|---|
| ORG-100051510 | Mural Health Technologies Inc. | 1189 Lancaster Avenue | Berwyn | 19312-1299 | United States | 1111 | xxx@xxxx.com | Other |
| 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-100012847 | QPS LLC | 3 Innovation Way Suite 204 | Newark | 19711-5456 | United States | 1111 | xxx@xxxx.com | Other |
| 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 |
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: