Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
33
Countries
1
Sites
1
Crohn's disease
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 6 Aug 2024 → ongoing
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513390-50-00
- EudraCT number
- 2020-004405-31
- ClinicalTrials.gov
- NCT03938701
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Crohn's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10058338 | Spondylarthritis | 10028395 |
| 20.1 | PT | 10021972 | Inflammatory bowel disease | 100000004856 |
| 23.1 | LLT | 10003268 | Arthritis rheumatoid | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- W.B. Nagengast
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- W.B. Nagengast
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 33 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University Medical Center Groningen
Department of Gastroenterology and Hepatology, Hanzeplein 1, 9713 GZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-08-06 | 2024-08-22 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Netherlands | Acceptable with conditions 2024-10-03
|
2024-10-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-25 | Netherlands | Acceptable 2025-07-16
|
2025-07-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-04 | Netherlands | Acceptable 2025-07-16
|
2025-08-04 |