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

Phase 2

Terminated

• Conditions: Colitis, Ulcerative
• Interventions: Drug: LYC-30937-EC

• Registration Number: NCT02764229
• Lead Sponsor: Lycera Corp.

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-04
• Study First Posted: 2016-05-06
• Study Start: 2016-11-01
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18
• Results First Submitted: 2019-01-29
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Results First Posted: 2019-03-27
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LYC-30937-EC	LYC-30937-EC	LYC-30937-EC 25 mg by mouth once daily

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment	46 weeks	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.

Trial Locations

Locations (2)

Lycera investigational site; 🇺🇸 San Antonio, Texas, United States

Lycera Investigational Site; 🇷🇸 Zrenjanin, Serbia