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 |
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.
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.
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
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