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



Status:Terminated
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/29/2019
Start Date:November 1, 2016
End Date:July 18, 2018

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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

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

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.

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
We found this trial at
10
sites
Miami, Florida 33176
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Miami, FL
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2800 Plymouth Road
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Chicago, Illinois 60637
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Chicago, IL
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Greenville, North Carolina 27834
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Greenville, NC
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Houston, Texas 76092
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Houston, TX
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Little Rock, Arkansas 72212
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Little Rock, AR
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Mission Hills, California 91345
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Mission Hills, CA
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Nashville, Tennessee 37212
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Nashville, TN
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Ostrava,
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San Antonio, Texas 78229
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San Antonio, TX
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