Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
220
Countries
4
Sites
10
Myeloproliferative Neoplasms
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
- 24 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-520353-21-00
- ClinicalTrials.gov
- NCT06313593
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Myeloproliferative Neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10077465 | Myeloproliferative neoplasm | 100000004864 |
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 Trials Information
Public contact point
- Organisation
- Incyte Corp.
- Contact name
- Clinical Trials Information
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruiting | 30 | 2 |
| Germany | Authorised, recruiting | 30 | 3 |
| Italy | Authorised, recruitment pending | 30 | 3 |
| Norway | Authorised, recruiting | 30 | 2 |
| Rest of world
United States
|
— | 100 | — |
Investigational sites
Hopital Saint Louis
Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Gustave Roussy
Hematology, 114 Rue Edouard Vaillant, 94800, Villejuif
Martin-Luther-Universitaet Halle-Wittenberg
Department of Hematology and Internal Oncology, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation ( MK IV), Pauwelsstrasse 30, 52074, Aachen
Azienda Ospedaliero Universitaria Careggi
Department of Experimental and Clinical Medicine, University of Florence, Section (SOD) Hematology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department of Oncological and Hematological Diseases, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Departmental of Hematology, Via Francesco Sforza 28, 20122, Milan
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 | 2026-02-24 | ||||
| Germany | 2026-03-25 | ||||
| Norway | 2026-03-25 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-04 | Norway | Acceptable 2026-01-14
|
2026-01-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-18 | Norway | Acceptable 2026-05-18
|
2026-05-18 |