A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
- Sponsor
- Incyte Corporation
- Study ID
- NCT03627052
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Moderate to Severe Ulcerative Colitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 74 Years
- Healthy Volunteers
- Not accepted
Interventions
- Itacitinib — DRUGIn the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. In the open-label extension, itacitinib administered at doses determined from the double-blind period.
- Placebo — DRUGPlacebo administered orally twice daily in the double-blind period.
Study Details
The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).
Key Dates
- Start date
- Sep 20, 2018
- Status verified
- Dec 2019
- Primary completion
- Nov 13, 2019
- Completion
- Nov 13, 2019
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Itacitinib
- Placebo Comparator: Placebo
Primary Outcome Measure
Proportion of participants with a Clinical Response [ Time Frame: Week 8 ]