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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02764229
Study type Interventional
Source Lycera Corp.
Contact
Status Terminated
Phase Phase 2
Start date November 1, 2016
Completion date July 18, 2018
View Details
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