Trials / Active Not Recruiting
Active Not RecruitingNCT04640025
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib (INCB039110)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | itacitinib | Participants will self-administer itacitinib orally using intact tablets with water and without regard to food. |
Timeline
- Start date
- 2021-03-10
- Primary completion
- 2026-06-22
- Completion
- 2026-06-22
- First posted
- 2020-11-23
- Last updated
- 2025-12-10
Locations
21 sites across 9 countries: United States, Austria, Belgium, Canada, Germany, Greece, Israel, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04640025. Inclusion in this directory is not an endorsement.