NCT03627052

A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).

Conditions

• Moderate to Severe Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Itacitinib	In 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.
DRUG	Placebo	Placebo administered orally twice daily in the double-blind period.

Timeline

• Start date: 2018-09-20
• Primary completion: 2019-11-13
• Completion: 2019-11-13
• First posted: 2018-08-13
• Last updated: 2019-12-06

Regulatory

• FDA-regulated drug study