Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
23
Countries
1
Sites
7
Thrombocythaemia
Key facts
- Sponsor
- Step Pharma
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 2 Jul 2025 → ongoing
- Decision date (initial)
- 2025-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519964-42-00
- ClinicalTrials.gov
- NCT06786234
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Thrombocythaemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10015493 | Essential thrombocythaemia | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Step Pharma
- Sponsor organisation
- Step Pharma
- Address
- 101 Rue De Sevres
- City
- Paris Cedex 06
- Postcode
- 75272
- Country
- France
Scientific contact point
- Organisation
- Step Pharma
- Contact name
- VP, Head of Clinical Operations
Public contact point
- Organisation
- Step Pharma
- Contact name
- VP, Head of Clinical Operations
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 13 | 7 |
| Rest of world
United Kingdom
|
— | 10 | — |
Investigational sites
Institut Paoli Calmettes
Service d‘Onco-Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut de Cancérologie du Gard
Hématologie Clinique, Rue du Pr Henri Pujol, 30000, NIMES
Hopital Saint Louis
Centre d’investigation Clinique, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Nantes
Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Hôpital Cavale Blanche CHU de Brest
Institut de Cancérologie et d’Imagerie, Bd Tanguy Prigent, 29069, Brest
Institut Gustave Roussy
Hématologie Clinique, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nice
Hematology, 151 Route De Saint Antoine, 06200, Nice
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 |
|---|---|---|---|---|---|
| France | 2025-07-02 | 2025-07-09 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-06 | France | Acceptable 2025-05-06
|
2025-05-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-03 | France | Acceptable 2025-05-06
|
2025-06-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-03 | France | Acceptable 2025-06-30
|
2025-07-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-29 | France | Acceptable 2025-10-14
|
2025-10-22 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-24 | France | Acceptable 2025-10-14
|
2025-10-24 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-07 | France | Acceptable 2025-10-14
|
2025-11-07 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-19 | France | Acceptable 2026-02-20
|
2026-02-20 |