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

Study Overview
=================
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.

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

Conditions
-----------------
Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease

Intervention / Treatment
-----------------
* Drug: itacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: itacitinib<br>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<br>* Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.<br>* Other names: INCB039110;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
itacitinib, INCB39110