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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: LYC-30937-EC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LYC-30937-EC<br>LYC-30937-EC 25 mg by mouth once daily | Drug: LYC-30937-EC<br>* LYC-30937-EC 25 mg by mouth once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment | Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death. | 46 weeks |