Clinical trial NCT02764229: Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Official title: A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colitis, Ulcerative
Lead sponsor: Lycera Corp.
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment
timeFrame: 46 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Lycera Investigational Site
state: Arkansas
city: Mission Hills
country: United States
facility: Lycera Investigational Site
state: California
city: Miami
country: United States
facility: Lycera Investigational Site
state: Florida
city: Chicago
country: United States
facility: Lycera Investigational Site
state: Illinois
city: Ann Arbor
country: United States
facility: Lycera Investigational Site
state: Michigan
city: Greenville
country: United States
facility: Lycera investigational site
state: North Carolina
city: Nashville
country: United States
facility: Lycera Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Lycera Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Lycera investigational site
state: Texas
city: Ostrava
country: Czechia
facility: Lycera Investigational Site
city: Praha 3
country: Czechia
facility: Lycera Investigational Site
city: Ústí Nad Labem
country: Czechia
facility: Lycera Investigational Site
city: Budapest
country: Hungary
facility: Lycera Investigational Site
city: Budapest
country: Hungary
facility: Lycera Investigational Site
city: Rotterdam
country: Netherlands
facility: Lycera Investigational Site
city: Bydgoszcz
country: Poland
facility: Lycera Investigational Site
city: Bydgoszcz
country: Poland
facility: Lycera Investigational Site
city: Katowice
country: Poland
facility: Lycera Investigational Site
city: Katowice
country: Poland
facility: Lycera Investigational Site
city: Katowice
country: Poland
facility: Lycera Investigational Site
city: Kielce
country: Poland
facility: Lycera Investigational Site
city: Kraków
country: Poland
facility: Lycera Investigational Site
city: Lublin
country: Poland
facility: Lycera Investigational Site
city: Piaseczno
country: Poland
facility: Lycera Investigational Site
city: Poznań
country: Poland
facility: Lycera Investigational Site
city: Skierniewice
country: Poland
facility: Lycera Investigational Site
city: Sopot
country: Poland
facility: Lycera Investigational Site
city: Staszów
country: Poland
facility: Lycera Investigational Site
city: Szczecin
country: Poland
facility: Lycera Investigational Site
city: Warszawa
country: Poland
facility: Lycera Investigational Site
city: Warszawa
country: Poland
facility: Lycera Investigational Site
city: Wloclawek
country: Poland
facility: Lycera Investigational Site
city: Wroclaw
country: Poland
facility: Lycera Investigational Site
city: Wrocław
country: Poland
facility: Lycera Investigational Site
city: Wrocław
country: Poland
facility: Lycera Investigational Site
city: Belgrade
country: Serbia
facility: Lycera Investigational Site
city: Kragujevac
country: Serbia
facility: Lycera Investigational Site
city: Niš
country: Serbia
facility: Lycera Investigational Site
city: Subotica
country: Serbia
facility: Lycera Investigational Site
city: Zrenjanin
country: Serbia
facility: Lycera Investigational Site
Study officials:
affiliation: Lycera Corp.
name: H. Jeffrey Wilkins, MD
role: STUDY_DIRECTOR
References: