Clinical trial • Phase I | Phase III • Oncology

INCB160058 for Myeloproliferative neoplasms

Phase I | Phase III trial of INCB160058 for Myeloproliferative neoplasms. open-label, none/not specified-controlled. 100 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Myeloproliferative neoplasms
Trial Stage
Phase I | Phase III

Key dates

Initial CTIS Submission Date
04-09-2025
First CTIS Authorization Date
14-01-2026

Trial design

open-label, none/not specified-controlled Phase I | Phase III trial in France, Germany, Italy and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
100

Recruitment

Planned Sample Size
100
Recruitment Window Months
37

Geography

Total Number Of Sites
10
Total Number Of Participants
120

France

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
14-01-2026
Processing Time Days
29
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
Institut Gustave Roussy
Department Name
Hematology
Principal Investigator Name
Vincent RIBRAG
Principal Investigator Email
vincent.ribrag@gustaveroussy.fr
Contact Person Name
Vincent RIBRAG
Site Name
Hopital Saint Louis
Department Name
Hematology
Principal Investigator Name
Jean_Jacques KILADJIAN
Principal Investigator Email
jean-jacques.kiladjian@aphp.fr
Contact Person Name
Jean_Jacques KILADJIAN
Contact Person Email
jean-jacques.kiladjian@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
17-12-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
30
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Principal Investigator Name
Joachim Göthert
Principal Investigator Email
Joachim.Goethert@uk-essen.de
Contact Person Name
Joachim Göthert
Contact Person Email
Joachim.Goethert@uk-essen.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Department of Hematology and Internal Oncology
Principal Investigator Name
Haifa Kathrin Al-Ali
Principal Investigator Email
haifa.al-ali@ul-halle.de
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
haifa.al-ali@ul-halle.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation ( MK IV)
Principal Investigator Name
Steffen Koschmieder
Principal Investigator Email
skoschmieder@ukaachen.de
Contact Person Name
Steffen Koschmieder
Contact Person Email
skoschmieder@ukaachen.de

Italy

Earliest CTIS Part Ii Submission Date
25-09-2025
Latest Decision Or Authorization Date
16-01-2026
Processing Time Days
113
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Departmental of Hematology
Principal Investigator Name
Francesco Passamonti
Principal Investigator Email
francesco.passamonti@policlinico.mi.it
Contact Person Name
Francesco Passamonti
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Department of Oncological and Hematological Diseases
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Department of Experimental and Clinical Medicine, University of Florence, Section (SOD) Hematology
Principal Investigator Name
Alessandro Maria Vannucchi
Principal Investigator Email
amvannucchi@unifi.it
Contact Person Name
Alessandro Maria Vannucchi
Contact Person Email
amvannucchi@unifi.it

Norway

Earliest CTIS Part Ii Submission Date
16-12-2025
Latest Decision Or Authorization Date
15-01-2026
Processing Time Days
30
Number Of Sites
2
Number Of Participants
30

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Hematology
Principal Investigator Name
Eivind Galteland
Principal Investigator Email
uxgaei@ous-hf.no
Contact Person Name
Eivind Galteland
Contact Person Email
uxgaei@ous-hf.no
Site Name
Helse Bergen HF
Department Name
Department of Hematology
Principal Investigator Name
Håkon Reikvam
Principal Investigator Email
hakon.reikvam@uib.no
Contact Person Name
Håkon Reikvam
Contact Person Email
hakon.reikvam@uib.no

Sponsor

Primary sponsor

Full Name
Incyte Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
INCB160058

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