NCT02764229

Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis

A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Lycera Corp. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to allow subjects completing study LYC-30937-2001 the opportunity to receive LYC-30937-EC 25 mg.

Detailed description

Subjects who complete the 8 week treatment period of the double-blind, placebo-controlled study LYC-30937-2001 will have the option of receiving LYC-30397-EC 25 mg PO QD in this open-label extension study (LYC-30937-2002). Subjects meeting eligibility criteria will enter this open-label extension trial upon completion of the LYC-30937-2001 Week 8 study procedures. This open-label extension study will consist of 44 weeks of treatment followed by a 2 weeks post-treatment follow-up.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	LYC-30937-EC	LYC-30937-EC 25 mg by mouth once daily

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-07-18
• Completion: 2018-07-18
• First posted: 2016-05-06
• Last updated: 2019-03-27
• Results posted: 2019-03-27

Locations

40 sites across 6 countries: United States, Czechia, Hungary, Netherlands, Poland, Serbia