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

• Status: Terminated
• Trial end date: 2018-07-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lycera Corp.

Criteria

Inclusion Criteria:

• Completed the 8-week double-blind treatment period of study LYC-30937-2001

• Male and females of childbearing potential must agree to use adequate birth control during the study and for 30 days after discontinuing study drug

• Non-pregnant, non-lactating females who are not planning to become pregnant while enrolled in this study

• Investigator considers it safe and potentially beneficial to participate

• Ability to provide written informed consent and to be compliant with study schedule

Exclusion Criteria:

• Subjects who completed study LYC-30937-2001, but who experienced a serious adverse event that was considered related to investigational product, has an unstable medical condition, or for any other reason in the opinion of the investigator should not participate in this study