Chronic Graft Versus Host Disease, Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans)
Conditions
Keywords
itacitinib, INCB39110
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.
Interventions
DRUGitacitinib
Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Individual patients will continue to be treated with itacitinib in accordance with the parent study under which they were enrolled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events (TEAE's) | 3 years | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. |
Countries
Austria, Belgium, Canada, Germany, Greece, Israel, Italy, Spain, United States
Contacts
STUDY_DIRECTORLance Leopold, MD
Incyte Corporation
Outcome results
None listed