Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
130
Countries
2
Sites
8
Anaemia associated with myelofibrosis
Key facts
- Sponsor
- Incyte Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Aug 2021 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-503624-83-00
- EudraCT number
- 2020-004029-21
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Anaemia associated with myelofibrosis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Incyte Corp.
- Sponsor organisation
- Incyte Corp.
- Address
- 1801 Augustine Cut Off
- City
- Wilmington
- Postcode
- 19803-4404
- Country
- United States
Scientific contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trial Information
Locations
2 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 40 | 3 |
| Italy | Ongoing, recruitment ended | 50 | 5 |
| Rest of world
United States
|
— | 40 | — |
Investigational sites
Hopital Saint Louis
Centre d'Investigations Cliniques, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli Calmettes
Hematology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire D'Angers
Blood diseases, 4 Rue Larrey, 49100, Angers
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Complex Operational Unit (UOC) Hematology - Via G. Massarenti 9 40138 Bologna Italy, Via Pietro Albertoni 15, 40138, Bologna
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Departmental of Oncology and Hematology, Piazza Oms 1, 24127, Bergamo
Careggi University Hospital
Departmental Hospital Section (SOD) of Hematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Hospital Santa Maria Della Misericordia
Departmental of Hematology, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Dpt of Clinical and Biological Sciences, Regione Gonzole 10, 10043, Orbassano
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 | 2021-08-16 | 2025-06-16 | 2021-08-16 | 2024-11-12 | |
| Italy | 2021-12-20 | 2021-12-20 | 2024-11-12 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | France | Acceptable 2024-09-05
|
2024-09-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-11 | Acceptable 2024-09-05
|
2025-03-11 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-07 | Acceptable 2024-09-05
|
2025-07-07 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-15 | Acceptable 2024-09-05
|
2025-07-15 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-21 | Acceptable 2024-09-05
|
2025-07-21 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-07-31 | Acceptable 2024-09-05
|
2025-07-31 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-12-03 | Acceptable 2024-09-05
|
2025-12-03 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-03-19 | Acceptable 2024-09-05
|
2026-03-19 |