Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
133
Countries
6
Sites
18
Systemic Sclerosis
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 29 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517681-41-00
- WHO UTN
- U1111-1308-9273
- ClinicalTrials.gov
- NCT07115745
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 100000004859 |
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
| 21.0 | LLT | 10042953 | Systemic sclerosis | 10028395 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Locations
6 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 11 | 2 |
| France | Authorised, recruiting | 9 | 2 |
| Germany | Ongoing, recruiting | 16 | 5 |
| Poland | Ongoing, recruiting | 20 | 4 |
| Romania | Authorised, recruiting | 26 | 2 |
| Spain | Ongoing, recruiting | 11 | 3 |
| Rest of world
Australia, Brazil, Israel
|
— | 40 | — |
Investigational sites
Fakultni Nemocnice Motol A Homolka
Oddeleni revmatologie deti a dospelych, V Uvalu 84/1, Motol, Prague
Revmatologicky Ustav
NA, Na Slupi 450/4, Nove Mesto, Prague 2
Les Hopitaux Universitaires De Strasbourg
Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Lille
Maladie du sang, Rue Michel Polonovski, 59037, Lille Cedex
Charite Universitaetsmedizin Berlin KöR
Rheumatologie, Immunologie, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Duesseldorf AöR
Rheumatologie, Moorenstrasse 5, Bilk, Duesseldorf
Technische Universitaet Dresden
Medizinische Klinik III, Abteilung für Rheumatologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Medical Center Hamburg-Eppendorf
Zentrum für Innere Medizin, III. Medizinische Klinik und Poliklinik (Nephr./Rheum./Endokr.), Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Innere Medizin, Haematologie und Onkologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddzial Reumatologii i Ukladowych Chorob Tkanki Lacznej, Ul. Pabianicka 62, 93-513, Lodz
Uniwersyteckie Centrum Kliniczne
Osrodek Badan Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
Oddzial Reumatologii i Rehabilitacji, Ul. Stefana Zeromskiego 7, 41-902, Bytom
Institutul Clinic Fundeni
Phase1Unit AEM in colab with Fundeni Clinical Institute Dep IV Hematology Bone Marrow Transplantat, Soseaua Fundeni 258, 022328, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Phase 1 Unit AEM in collab with IOCN, Radiotherapy departament, Strada Republicii 34-36, 400015, Cluj-Napoca
Hospital Universitari Vall D Hebron
Reumatologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Servicio de Reumatologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
Reumatologia, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2026-01-20 | 2026-03-11 | |||
| France | 2025-10-16 | ||||
| Germany | 2025-10-01 | 2026-02-20 | |||
| Poland | 2025-08-29 | 2025-09-04 | |||
| Romania | 2025-09-02 | ||||
| Spain | 2025-09-16 | 2026-02-26 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-21 | Spain | Acceptable with conditions 2025-07-14
|
2025-07-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-22 | Acceptable with conditions 2025-07-14
|
2025-07-22 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-22 | Spain | Acceptable with conditions 2025-07-14
|
2025-07-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-23 | Acceptable with conditions 2025-07-14
|
2025-07-23 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-23 | Acceptable with conditions 2025-07-14
|
2025-07-23 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-24 | Acceptable with conditions 2025-07-14
|
2025-07-24 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-24 | Acceptable with conditions | 2025-07-30 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-07 | Acceptable with conditions | 2025-10-31 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-13 | Spain | Acceptable 2026-05-21
|
2026-05-22 |