Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
118
Countries
4
Sites
13
Myasthenia gravis (MG)
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 22 May 2024 → ongoing
- Decision date (initial)
- 2024-05-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507820-22-00
- WHO UTN
- U1111-1296-8579
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myasthenia gravis (MG)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028417 | Myasthenia gravis | 100000004852 |
| 20.1 | PT | 10028245 | Multiple sclerosis | 100000004852 |
| 21.0 | PT | 10080700 | Relapsing multiple sclerosis | 100000004852 |
| 26.1 | PT | 10053395 | Progressive multiple sclerosis | 100000004852 |
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
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Temporarily halted | 9 | 2 |
| France | Temporarily halted | 10 | 2 |
| Germany | Temporarily halted | 11 | 5 |
| Spain | Temporarily halted | 26 | 4 |
| Rest of world
United States, United Kingdom
|
— | 62 | — |
Investigational sites
Antwerp University Hospital
Neurology, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Neurology, Corneel Heymanslaan 10, 9000, Gent
Centre Hospitalier Universitaire De Lille
Service Maladies du sang, 1 Place De Verdun, 59000, Lille
Assistance Publique Hopitaux De Paris
Service de Neurologie - CIC Neurosciences, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Universitaetsklinikum Essen AöR
Neurology, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Duesseldorf AöR
Neurology, Moorenstrasse 5, Bilk, Duesseldorf
Klinikum der Universitaet Muenchen AöR
Clinical Neuroimmunology, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Erlangen AöR
Hematology and Oncology, Ulmenweg 18, Innenstadt, Erlangen
Otto Von Guericke Universitaet Magdeburg
Hematology/Oncology, Leipziger Strasse 44, Leipziger Str., Magdeburg
Hospital Universitario Ramon Y Cajal
Neurology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinic De Barcelona
Neurology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Neurology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, 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 |
|---|---|---|---|---|---|
| Belgium | 2024-07-18 | 2025-01-22 | 2026-05-29 | ||
| France | 2025-04-28 | 2025-06-16 | 2026-05-29 | ||
| Germany | 2024-05-23 | 2024-06-04 | 2026-05-29 | ||
| Spain | 2024-05-22 | 2024-07-16 | 2026-05-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-137035
- Halt date
- 2026-05-29
- Member states concerned
- Germany
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the DIL uploaded as a supporting document.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137033
- Halt date
- 2026-05-29
- Member states concerned
- Spain
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the DIL uploaded as a supporting document.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137039
- Halt date
- 2026-05-29
- Member states concerned
- Belgium
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the DIL uploaded as a supporting document.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Temporary halt TH-137037
- Halt date
- 2026-05-29
- Member states concerned
- France
- Publication date
- 2026-06-02
- Reason
- Sponsor decision
- Follow-up measures
- Please refer to the DIL uploaded as a supporting document.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-08 | Germany | Acceptable 2024-04-30
|
2024-05-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-02 | Acceptable 2024-04-30
|
2024-05-02 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-03 | Acceptable 2024-04-30
|
2024-05-03 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-05-06 | Acceptable 2024-04-30
|
2024-05-06 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-05-07 | Germany | Acceptable 2024-04-30
|
2024-05-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-08 | Acceptable | 2024-05-22 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-05-22 | Germany | 2024-05-22 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2024-05-31 | Germany | 2024-05-31 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-17 | Germany | Acceptable 2024-10-21
|
2024-10-21 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2024-10-30 | Germany | Acceptable 2024-10-21
|
2024-10-30 |
| 11 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-19 | Germany | Acceptable 2025-03-03
|
2025-03-03 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2025-03-06 | Germany | Acceptable 2025-03-03
|
2025-03-06 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-9 | 2025-03-06 | Acceptable 2025-03-03
|
2025-03-06 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-10 | 2025-03-06 | Acceptable 2025-03-03
|
2025-03-06 | |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-11 | 2025-04-30 | Germany | Acceptable 2025-03-03
|
2025-04-30 |
| 16 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-09 | Germany | Acceptable 2025-10-13
|
2025-10-14 |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-12 | 2025-10-17 | Germany | Acceptable 2025-10-13
|
2025-10-17 |
| 18 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-03 | Germany | Acceptable 2026-03-09
|
2026-03-09 |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-13 | 2026-03-18 | Germany | Acceptable 2026-03-09
|
2026-03-18 |