Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
35
Countries
2
Sites
4
Cutaneous T-cell lymphomas (CTCL)
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2025-09-26
- 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
Cutaneous T-cell lymphomas (CTCL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
| 28.0 | PT | 10011677 | Cutaneous T-cell lymphoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Caroline Ram Wolff
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Caroline Ram Wolff
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 32 | 3 |
| Spain | Authorised, recruitment pending | 3 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Dermatologie, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Hospices Civils De Lyon
Dermatologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Assistance Publique Hopitaux De Paris
Dermatologie, 1 Avenue Claude Vellefaux, 75010, Paris
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-10 | France | Acceptable 2025-09-26
|
2025-09-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-20 | France | Acceptable 2026-02-27
|
2026-02-27 |