Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
16
Countries
1
Sites
1
inflammatory and autoimmune diseases
Key facts
- Sponsor
- Galapagos
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-04-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
inflammatory and autoimmune diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061664 | Autoimmune disorder | 100000004870 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Galapagos
- Sponsor organisation
- Galapagos
- Address
- Generaal De Wittelaan L11 A3
- City
- Mechelen
- Postcode
- 2800
- Country
- Belgium
Scientific contact point
- Organisation
- Galapagos
- Contact name
- Galapagos Medical Information
Public contact point
- Organisation
- Galapagos
- Contact name
- Galapagos Medical Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-23 | Belgium | Acceptable 2026-04-27
|
2026-04-27 |