NCT03733314

A Study of E6011 in Participants With Active Crohn's Disease

Early Phase 2 Clinical Trial of E6011 in Patients With Active Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: EA Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to examine the efficacy and safety of E6011 at 12 weeks after administration by means of double-blind placebo-controlled trial.

Detailed description

Participants with moderate to severe Crohn's disease will be enrolled in this study. The study will include screening period, remission-induction period (double-blind), rescue period (open-label), extension period (open-label), post-observation period, and a follow-up period. At the end of remission-induction period, participants with reduction in Crohn's disease activity index (CDAI) score of 70 points or more when compared to baseline will move on to the open-label extension period, and participants with less than 70 points reduction in CDAI score will move on to the rescue period. At the end of the rescue period, participants with a reduction in the CDAI of 70 points or more will move on to the open-label extension period and with less than 70 points reduction in the CDAI score will be discontinued. The post-observation period will include in-person assessment after the completion or discontinuation of the extension period, and participants will be contacted by telephone, etc. after the last dose of study drug administration. Participants will be contacted over phone after the last dose of study drug administration for follow up assessments.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	E6011	E6011, infusion, intravenously.
DRUG	Placebo	Placebo, infusion, intravenously.

Timeline

• Start date: 2019-04-25
• Primary completion: 2022-03-16
• Completion: 2024-04-03
• First posted: 2018-11-07
• Last updated: 2025-04-02
• Results posted: 2025-04-02

Locations

46 sites across 5 countries: Czechia, Hungary, Japan, Poland, Russia