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

March 5, 2019 updated by: Lycera Corp.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Ostrava, Czechia, 722 00
        • Lycera Investigational Site
      • Praha 3, Czechia, 130 00
        • Lycera Investigational Site
      • Ústí Nad Labem, Czechia, 401 13
        • Lycera Investigational Site
  • Hungary
      • Budapest, Hungary, 1088
        • Lycera Investigational Site
      • Budapest, Hungary, 1125
        • Lycera Investigational Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Lycera Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Lycera Investigational Site
      • Bydgoszcz, Poland, 85-681
        • Lycera Investigational Site
      • Katowice, Poland, 40-211
        • Lycera Investigational Site
      • Katowice, Poland, 40-659
        • Lycera Investigational Site
      • Katowice, Poland, 40-752
        • Lycera Investigational Site
      • Kielce, Poland, 25-355
        • Lycera Investigational Site
      • Kraków, Poland, 31-009
        • Lycera Investigational Site
      • Lublin, Poland, 20-362
        • Lycera Investigational Site
      • Piaseczno, Poland, 05-500
        • Lycera Investigational Site
      • Poznań, Poland, 61-113
        • Lycera Investigational Site
      • Skierniewice, Poland, 96-100
        • Lycera Investigational Site
      • Sopot, Poland, 81-756
        • Lycera Investigational Site
      • Staszów, Poland, 28-200
        • Lycera Investigational Site
      • Szczecin, Poland, 71-270
        • Lycera Investigational Site
      • Warszawa, Poland, 02-507
        • Lycera Investigational Site
      • Warszawa, Poland, 04-749
        • Lycera Investigational Site
      • Wloclawek, Poland, 87-800
        • Lycera Investigational Site
      • Wroclaw, Poland, 50-449
        • Lycera Investigational Site
      • Wrocław, Poland, 53-333
        • Lycera Investigational Site
      • Wrocław, Poland
        • Lycera Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Lycera Investigational Site
      • Kragujevac, Serbia, 34000
        • Lycera Investigational Site
      • Niš, Serbia, 18000
        • Lycera Investigational Site
      • Subotica, Serbia, 24000
        • Lycera Investigational Site
      • Zrenjanin, Serbia, 23000
        • Lycera Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Lycera Investigational Site
    • California
      • Mission Hills, California, United States, 91345
        • Lycera Investigational Site
    • Florida
      • Miami, Florida, United States, 33176
        • Lycera Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Lycera Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Lycera Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Lycera Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Lycera Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Lycera Investigational Site
      • San Antonio, Texas, United States, 78229
        • Lycera Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LYC-30937-EC
LYC-30937-EC 25 mg by mouth once daily
Drug: LYC-30937-EC
LYC-30937-EC 25 mg by mouth once daily

What is the study measuring?

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
Time Frame: 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.
46 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lycera Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

July 18, 2018

Study Completion (ACTUAL)

July 18, 2018

Study Registration Dates

First Submitted

May 4, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (ESTIMATE)

May 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LYC-30937-2002
  • 2016-003633-26 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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