Clinical trial • Phase I • Musculoskeletal | Immunology

Clinical trial in Axial spondyloarthritis

Phase I trial for Axial spondyloarthritis. 48 participants.

Overview

Trial Therapeutic Area
Musculoskeletal | Immunology
Trial Disease
Axial spondyloarthritis
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
02-07-2025
First CTIS Authorization Date
06-10-2025

Trial design

Phase I trial across 5 sites in Belgium, Germany, Netherlands.

Target Sample Size
48

Eligibility

Recruits 48 No vulnerable populations selected (isVulnerablePopulationSelected: false).

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false)

Recruitment

Planned Sample Size
48
Recruitment Window Months
9

Geography

Total Number Of Sites
5
Total Number Of Participants
20

Belgium

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
128
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Rheumatology
Contact Person Name
Filip Van den Bosch
Contact Person Email
filip.vandenbosch@ugent.be
Site Name
UZ Leuven
Department Name
Rheumatology
Contact Person Name
Kurt De Vlam
Contact Person Email
kurt.devlam@uzleuven.be

Germany

Earliest CTIS Part Ii Submission Date
22-09-2025
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
122
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Gastroenterologie, Infektiologie und Rheumatologie
Contact Person Name
Valeria Rios Rodriguez
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Rheumazentrum
Contact Person Name
Xenofon Baraliakos
Contact Person Email
baraliakos@me.com

Netherlands

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
124
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Amsterdam UMC Stichting
Department Name
Rheumatology and Clinical Immunology
Contact Person Name
Marleen van de Sande
Contact Person Email
m.g.vandesande@amsterdamumc.nl

Sponsor

Primary sponsor

Full Name
Grey Wolf Therapeutics Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

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