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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2018-07-18

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.

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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.

Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LYC-30937-EC

LYC-30937-EC 25 mg by mouth once daily

Group Type EXPERIMENTAL

LYC-30937-EC

Intervention Type DRUG

LYC-30937-EC 25 mg by mouth once daily

Interventions

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LYC-30937-EC

LYC-30937-EC 25 mg by mouth once daily

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No