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

NCT04640025 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: INCB 39110-8012022-501661-47-002020-002134-32
• Study Type: interventional
• Target: 18
• Locations: 9 countries
• Sites: 21

Brief Summary

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.

Conditions

Chronic Graft Versus Host Disease; Myelofibrosis; Postlung Transplant (Bronchiolitis Obliterans)

Keywords

itacitinib; INCB39110

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events (TEAE's)

  Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

  3 years

Study Arms (1)

itacitinib

EXPERIMENTAL

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

Interventions

itacitinib DRUG

Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.

Also known as: INCB039110

itacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (21)

City of Hope National Medical Center

Duarte, California, 31010, United States

Location

Anschutz Cancer Pavilion-University of Colorado

Aurora, Colorado, 80045, United States

Location

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Department of Thoracic Medicine and Surgery

Philadelphia, Pennsylvania, 19140, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Texas Oncology San Antonio

San Antonio, Texas, 78240, United States

Location

Ordensklinikum Linz Gmbh Elisabethinen

Linz, 04020, Austria

Location

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, 03000, Belgium

Location

Providence Health

Vancouver, British Columbia, V6Z 2A5, Canada

Location

Universitatsklinikum Halle (Saale)

Halle, D06120, Germany

Location

University Medical Centre Hamburg-Eppendorf Centre of Oncology

Hamburg, 20251, Germany

Location

University Hospital Mannheim

Mannheim, 68167, Germany

Location

University Hospital of West Attica - Attikon

Chaïdári, 12462, Greece

Location

Hadassah Hebrew University Medical Center Ein Karem Hadassah

Jerusalem, 91120, Israel

Location

Azienda Policlinico Vittorio Emanuele

Catania, 95123, Italy

Location

Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

Reggio Calabria, 89100, Italy

Location

Aou San Giovanni Di Dio E Ruggi

Salerno, 84131, Italy

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18012, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

Related Links

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

MeSH Terms

Conditions

Primary Myelofibrosis; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome

Interventions

itacitinib; INCB039110

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Organizing Pneumonia; Graft vs Host Disease; Immune System Diseases

Study Officials

• Lance Leopold, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 23, 2020
• Study Start: March 10, 2021
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 22, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

ES (2); DE (3); IL (1); AU (1); IT (3); GR (1); CA (1); US (8); BE (1)