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

Colitis, Ulcerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02764229
• Other study ID #: LYC-30937-2002
• Secondary ID: 2016-003633-26
• Status: Terminated
• Phase: Phase 2
• Start date: November 1, 2016
• Est. completion date: July 18, 2018

Study information

• Verified date: March 2019
• Source: Lycera Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• LYC-30937-EC
LYC-30937-EC 25 mg by mouth once daily

Locations

Country	Name	City	State
Czechia	Lycera Investigational Site	Ostrava
Czechia	Lycera Investigational Site	Praha 3
Czechia	Lycera Investigational Site	Ústí Nad Labem
Hungary	Lycera Investigational Site	Budapest
Hungary	Lycera Investigational Site	Budapest
Netherlands	Lycera Investigational Site	Rotterdam
Poland	Lycera Investigational Site	Bydgoszcz
Poland	Lycera Investigational Site	Bydgoszcz
Poland	Lycera Investigational Site	Katowice
Poland	Lycera Investigational Site	Katowice
Poland	Lycera Investigational Site	Katowice
Poland	Lycera Investigational Site	Kielce
Poland	Lycera Investigational Site	Kraków
Poland	Lycera Investigational Site	Lublin
Poland	Lycera Investigational Site	Piaseczno
Poland	Lycera Investigational Site	Poznan
Poland	Lycera Investigational Site	Skierniewice
Poland	Lycera Investigational Site	Sopot
Poland	Lycera Investigational Site	Staszów
Poland	Lycera Investigational Site	Szczecin
Poland	Lycera Investigational Site	Warszawa
Poland	Lycera Investigational Site	Warszawa
Poland	Lycera Investigational Site	Wloclawek
Poland	Lycera Investigational Site	Wroclaw
Poland	Lycera Investigational Site	Wroclaw
Poland	Lycera Investigational Site	Wroclaw
Serbia	Lycera Investigational Site	Belgrade
Serbia	Lycera Investigational Site	Kragujevac
Serbia	Lycera Investigational Site	Niš
Serbia	Lycera Investigational Site	Subotica
Serbia	Lycera Investigational Site	Zrenjanin
United States	Lycera Investigational Site	Ann Arbor	Michigan
United States	Lycera Investigational Site	Chicago	Illinois
United States	Lycera investigational site	Greenville	North Carolina
United States	Lycera Investigational Site	Houston	Texas
United States	Lycera Investigational Site	Little Rock	Arkansas
United States	Lycera Investigational Site	Miami	Florida
United States	Lycera Investigational Site	Mission Hills	California
United States	Lycera Investigational Site	Nashville	Tennessee
United States	Lycera investigational site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Lycera Corp.

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Netherlands,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment	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