NCT03018054

Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: EA Pharma Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg), E6007 60 mg or placebo.

Conditions

• Moderate Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	E6007	once daily administration
DRUG	Placebo	once daily administration

Timeline

• Start date: 2016-11-28
• Primary completion: 2019-04-17
• Completion: 2019-08-16
• First posted: 2017-01-11
• Last updated: 2019-10-04

Locations

64 sites across 1 country: Japan