A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

December 4, 2025 updated by: Incyte Corporation

A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)

This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol".

Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 04020
        • Ordensklinikum Linz GmbH Elisabethinen
  • Belgium
      • Leuven, Belgium, 03000
        • Universitaire Ziekenhuis Leuven - Gasthuisberg
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2A5
        • Providence Health
  • Germany
      • Halle, Germany, D06120
        • Universitatsklinikum Halle (Saale)
      • Hamburg, Germany, 20251
        • University Medical Centre Hamburg-Eppendorf Centre of Oncology
      • Mannheim, Germany, 68167
        • University Hospital Mannheim
  • Greece
      • Chaïdári, Greece, 12462
        • University Hospital of West Attica - Attikon
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Medical Center Ein Karem Hadassah
  • Italy
      • Catania, Italy, 95123
        • Azienda Policlinico Vittorio Emanuele
      • Reggio Calabria, Italy, 89100
        • Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti
      • Salerno, Italy, 84131
        • Aou San Giovanni Di Dio E Ruggi
  • Spain
      • Granada, Spain, 18012
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
  • United States
    • California
      • Duarte, California, United States, 31010
        • City of Hope National Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Anschutz Cancer Pavilion-University of Colorado
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Department of Thoracic Medicine and Surgery
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • San Antonio, Texas, United States, 78240
        • Texas Oncology San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Currently enrolled and receiving treatment in an Incyte-sponsored itacitinib (INCB39110)-based clinical study (parent Protocol).
  • Currently tolerating treatment as defined by the parent Protocol.
  • Currently receiving clinical benefit from itacitinib-based treatment, as determined by the investigator.
  • Has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this Protocol.
  • Willingness to avoid pregnancy or fathering children..
  • Ability to comprehend and willingness to sign an ICF.

Exclusion Criteria:

  • Able to access itacitinib therapy commercially.
  • Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: itacitinib
Participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. Participants who are receiving ruxolitinib under parent protocol INCB39110-209 may continue to receive it as described in that protocol.
Drug: itacitinib
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
Other Names:
  • INCB039110

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Emergent Adverse Events (TEAE's)
Time Frame: 3 years
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Lance Leopold, MD, Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Estimated)

June 22, 2026

Study Completion (Estimated)

June 22, 2026

Study Registration Dates

First Submitted

November 18, 2020

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 39110-801
  • 2020-002134-32 (EudraCT Number)
  • 2022-501661-47-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

IPD Sharing Time Frame

Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.

IPD Sharing Access Criteria

Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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