Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
56
Countries
1
Sites
1
Crohn's disease
Key facts
- Sponsor
- University Medical Center 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
- 14 Feb 2025 → ongoing
- Decision date (initial)
- 2024-10-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506192-10-00
- ClinicalTrials.gov
- NCT05725876
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Crohn's disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Medical Center Groningen
- Sponsor organisation
- University Medical Center Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- University Medical Center Groningen
- Contact name
- Wouter Nagengast
Public contact point
- Organisation
- University Medical Center Groningen
- Contact name
- Wouter Nagengast
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 56 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Gastroenterology, 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 | 2025-02-14 | 2025-02-14 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Netherlands | Acceptable 2024-10-24
|
2024-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-19 | Netherlands | Acceptable with conditions 2025-08-25
|
2025-09-01 |