Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
4
Knee osteoarthritis
Key facts
- Sponsor
- 4moving Biotech
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 10 May 2023 → 31 Oct 2023
- Decision date (initial)
- 2022-06-23
- 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
Knee osteoarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10031161 | Osteoarthritis | 100000004859 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
4moving Biotech
- Sponsor organisation
- 4moving Biotech
- Address
- Campus De L'institut Pasteur De Lille, 1 Rue Du Professeur Calmette 1 Rue Du Professeur Calmette
- City
- Lille
- Postcode
- 59800
- Country
- France
Scientific contact point
- Organisation
- 4moving Biotech
- Contact name
- Francis Berenbaum
Public contact point
- Organisation
- 4moving Biotech
- Contact name
- Francis Berenbaum
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 32 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Az Maria Middelares Gent
Orthopedics, Buitenring-Sint-Denijs 30, 9000, Gent
UZ Leuven
Head of Clinic, department of Rheumatology, University Hospitals, Leuven, Belgium, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Head of clinic of orthopeadic and traumatology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Medisch Centrum Latem
Knee clinic, Kortrijksesteenweg 53, 9830, Sint-Martens-Latem
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 | 2022-09-26 | 2023-10-31 | 2022-09-26 | 2023-10-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-1659
- Halt date
- 2023-04-18
- Planned restart
- 2023-05-16
- Member states concerned
- Belgium
- Publication date
- 2023-05-09
- Reason
- Investigator/Site related, Sponsor decision
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-06 | Belgium | Acceptable 2022-06-23
|
2022-06-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-05-16 | Belgium | Acceptable 2022-06-23
|
2023-05-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-07-18 | Belgium | Acceptable 2023-08-01
|
2023-08-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-09-04 | Belgium | Acceptable | 2023-09-18 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-09-21 | Belgium | Acceptable | 2023-09-21 |