Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
84
Countries
5
Sites
10
Axial spondyloarthritis
Key facts
- Sponsor
- Grey Wolf Therapeutics Limited
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 5 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Axial spondyloarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10071400 | Axial spondyloarthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Grey Wolf Therapeutics Limited
- Sponsor organisation
- Grey Wolf Therapeutics Limited
- Address
- 99 Park Drive, Milton Milton
- City
- Abingdon
- Postcode
- OX14 4RY
- Country
- United Kingdom
Scientific contact point
- Organisation
- Grey Wolf Therapeutics Limited
- Contact name
- Grey Wolf
Public contact point
- Organisation
- Grey Wolf Therapeutics Limited
- Contact name
- Grey Wolf
Locations
5 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 8 | 2 |
| Germany | Ongoing, recruiting | 8 | 2 |
| Netherlands | Ongoing, recruiting | 4 | 1 |
| Poland | Authorised, recruitment pending | 8 | 2 |
| Spain | Authorised, recruitment pending | 8 | 3 |
| Rest of world
Australia
|
— | 48 | — |
Investigational sites
UZ Leuven
Rheumatology, Herestraat 49, 3000, Leuven
Universitair Ziekenhuis Gent
Rheumatology, Corneel Heymanslaan 10, 9000, Gent
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Rheumazentrum, Claudiusstrasse 45, Wanne, Herne
Charite Universitaetsmedizin Berlin KöR
Gastroenterologie, Infektiologie und Rheumatologie, Hindenburgdamm 30, Lichterfelde, Berlin
Amsterdam UMC Stichting
Rheumatology and Clinical Immunology, Meibergdreef 9, 1105 AZ, Amsterdam
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 | 2025-11-05 | ||||
| Germany | 2025-11-14 | 2026-03-17 | |||
| Netherlands | 2025-12-11 | 2026-04-08 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-02 | Belgium | Acceptable 2025-10-01
|
2025-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-25 | Belgium | Acceptable 2026-01-20
|
2026-01-22 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-03-06 | Acceptable 2026-01-20
|
2026-05-19 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-03-10 | Acceptable 2026-01-20
|
2026-06-03 |