Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
270
Countries
5
Sites
22
Systemic Sclerosis
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 15 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503823-24-01
- WHO UTN
- U1111-1289-8030
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Systemic Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10042953 | Systemic sclerosis | 10028395 |
| 21.1 | PT | 10042945 | Systemic lupus erythematosus | 100000004859 |
| 24.1 | PT | 10085970 | Idiopathic inflammatory myopathy | 100000004859 |
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Locations
5 EU/EEA countries · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 11 | 1 |
| France | Temporarily halted | 31 | 7 |
| Germany | Temporarily halted | 57 | 7 |
| Italy | Temporarily halted | 7 | 2 |
| Spain | Temporarily halted | 20 | 5 |
| Rest of world
United States
|
— | 144 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Unité de Médecine Interne (UF 04) : CRMR MATHEC, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Bordeaux
Hématologie clinique et thérapie cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Montpellier
Unité Immuno-rhumatologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nice
Immunologie Clinique, 151 Route De Saint Antoine, 06200, Nice
Les Hopitaux Universitaires De Strasbourg
Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Lille
service maladie du sang, 1 Place De Verdun, 59000, Lille
Centre Hospitalier Universitaire De Rennes
département d'hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Universitaetsklinikum Magdeburg AöR
Universitätsklinik für Hämatologie, Onkologie und Zelltherapie, Leipziger Strasse 44, 39120, Magdeburg
University Hospital Cologne AöR
Innere Medizin I, Kerpener Strasse 62, Lindenthal, Cologne
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 3 (M3), Ulmenweg 18, Innenstadt, Erlangen
Charite Universitaetsmedizin Berlin KöR
Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik Poliklinik II, Zentrum für Innere Medizin, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Duesseldorf AöR
Klinik für Rheumatologie, Moorenstrasse 5, Bilk, Duesseldorf
Humanitas Research Hospital
Oncology and Haematology, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Rheumatology, Largo Francesco Vito 1, 00168, Rome
Hospital Universitario Regional De Malaga
Rheumatology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Clinic De Barcelona
Rheumatology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Rheumatology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Marques De Valdecilla
Rheumatology, 5 Planta, Avenida Valdecilla S/n, Santander
Hospital Universitario Reina Sofia
Rheumatology, Avenida Menendez Pidal S/n, 14004, Cordoba
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 |
|---|---|---|---|---|---|
| Belgium | 2024-04-23 | 2024-05-06 | 2026-05-29 | ||
| France | 2024-04-15 | 2024-05-06 | 2026-05-29 | ||
| Germany | 2024-04-15 | 2024-06-28 | 2026-05-29 | ||
| Italy | 2024-06-06 | 2025-02-25 | 2026-05-29 | ||
| Spain | 2024-04-24 | 2025-04-08 | 2026-05-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 5 · Art. 38 CTR
Temporary halt TH-137046
- Halt date
- 2026-05-29
- Member states concerned
- Spain
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Dear investigator letter uploaded as supporting documentation
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137044
- Halt date
- 2026-05-29
- Member states concerned
- Belgium
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Dear investigator letter uploaded as supporting documentation
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137042
- Halt date
- 2026-05-29
- Member states concerned
- Italy
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Dear investigator letter uploaded as supporting documentation
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137050
- Halt date
- 2026-05-29
- Member states concerned
- Germany
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Dear investigator letter uploaded as supporting documentation
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137048
- Halt date
- 2026-05-29
- Member states concerned
- France
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the Dear investigator letter uploaded as supporting documentation
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
27 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-30 | Germany | Acceptable 2024-04-09
|
2024-04-09 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-15 | Germany | Acceptable 2024-04-09
|
2024-04-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-15 | Acceptable | 2024-04-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-05-08 | Germany | Acceptable 2024-08-19
|
2024-08-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-26 | Germany | Acceptable 2024-08-19
|
2024-08-26 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-08-28 | Germany | Acceptable 2024-08-19
|
2024-08-28 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-08-28 | Germany | Acceptable 2024-08-19
|
2024-08-28 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-09-04 | Germany | Acceptable 2024-08-19
|
2024-09-04 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-27 | Germany | Acceptable 2024-12-16
|
2024-12-16 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-01-07 | Germany | Acceptable 2024-12-16
|
2025-01-07 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2025-01-07 | Germany | Acceptable 2024-12-16
|
2025-01-07 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-01-10 | Acceptable 2024-12-16
|
2025-01-10 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-01-13 | Germany | Acceptable 2024-12-16
|
2025-01-13 |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2025-01-17 | Germany | Acceptable 2024-12-16
|
2025-01-17 |
| 15 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-28 | Germany | Acceptable 2025-04-22
|
2025-04-22 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2025-04-30 | Germany | Acceptable 2025-04-22
|
2025-04-30 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-13 | 2025-06-06 | Germany | Acceptable 2025-04-22
|
2025-06-06 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-14 | 2025-06-12 | Germany | Acceptable 2025-04-22
|
2025-06-12 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-15 | 2025-07-02 | Germany | Acceptable 2025-04-22
|
2025-07-02 |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-16 | 2025-07-04 | Germany | Acceptable 2025-04-22
|
2025-07-04 |
| 21 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-07-28 | Germany | Acceptable 2025-11-03
|
2025-11-04 |
| 22 | NON SUBSTANTIAL MODIFICATION | NSM-17 | 2025-11-10 | Germany | Acceptable 2025-11-03
|
2025-11-10 |
| 23 | NON SUBSTANTIAL MODIFICATION | NSM-18 | 2025-11-13 | Germany | Acceptable 2025-11-03
|
2025-11-13 |
| 24 | NON SUBSTANTIAL MODIFICATION | NSM-19 | 2025-11-24 | Germany | Acceptable 2025-11-03
|
2025-11-24 |
| 25 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-09 | Germany | Acceptable 2026-03-30
|
2026-03-31 |
| 26 | NON SUBSTANTIAL MODIFICATION | NSM-20 | 2026-04-06 | Germany | Acceptable 2026-03-30
|
2026-04-06 |
| 27 | NON SUBSTANTIAL MODIFICATION | NSM-21 | 2026-04-06 | Germany | Acceptable 2026-03-30
|
2026-04-06 |