Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
180
Countries
1
Sites
4
knee osteoarthritis
Key facts
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2024-05-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507683-40-00
- ClinicalTrials.gov
- NCT06084637
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
knee osteoarthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10023476 | Knee osteoarthritis | 10028395 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Marseille
- Sponsor organisation
- Assistance Publique Hopitaux De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Marseille
- Contact name
- Pr. Alexandre ROCHEWERGER
Public contact point
- Organisation
- Assistance Publique Hopitaux De Marseille
- Contact name
- Pr. Alexandre ROCHEWERGER
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 180 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-20 | France | Acceptable with conditions 2024-05-29
|
2024-05-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-05 | France | Acceptable 2025-10-23
|
2025-10-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-09 | France | Acceptable 2026-03-02
|
2026-03-03 |