Study Stopped
Lack of efficacy of test drug
Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
2 other identifiers
interventional
112
6 countries
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2016
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2018
CompletedResults Posted
Study results publicly available
March 27, 2019
CompletedMarch 27, 2019
March 1, 2019
1.7 years
May 4, 2016
January 29, 2019
March 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
LYC-30937-EC
EXPERIMENTALLYC-30937-EC 25 mg by mouth once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lycera Corp.lead
Study Sites (40)
Lycera Investigational Site
Little Rock, Arkansas, 72212, United States
Lycera Investigational Site
Mission Hills, California, 91345, United States
Lycera Investigational Site
Miami, Florida, 33176, United States
Lycera Investigational Site
Chicago, Illinois, 60637, United States
Lycera Investigational Site
Ann Arbor, Michigan, 48109, United States
Lycera investigational site
Greenville, North Carolina, 27834, United States
Lycera Investigational Site
Nashville, Tennessee, 37212, United States
Lycera Investigational Site
Houston, Texas, 77030, United States
Lycera investigational site
San Antonio, Texas, 78229, United States
Lycera Investigational Site
Ostrava, 722 00, Czechia
Lycera Investigational Site
Prague, 130 00, Czechia
Lycera Investigational Site
Ústí nad Labem, 401 13, Czechia
Lycera Investigational Site
Budapest, 1088, Hungary
Lycera Investigational Site
Budapest, 1125, Hungary
Lycera Investigational Site
Rotterdam, 3015 CE, Netherlands
Lycera Investigational Site
Bydgoszcz, 85-168, Poland
Lycera Investigational Site
Bydgoszcz, 85-681, Poland
Lycera Investigational Site
Katowice, 40-211, Poland
Lycera Investigational Site
Katowice, 40-659, Poland
Lycera Investigational Site
Katowice, 40-752, Poland
Lycera Investigational Site
Kielce, 25-355, Poland
Lycera Investigational Site
Krakow, 31-009, Poland
Lycera Investigational Site
Lublin, 20-362, Poland
Lycera Investigational Site
Piaseczno, 05-500, Poland
Lycera Investigational Site
Poznan, 61-113, Poland
Lycera Investigational Site
Skierniewice, 96-100, Poland
Lycera Investigational Site
Sopot, 81-756, Poland
Lycera Investigational Site
Staszów, 28-200, Poland
Lycera Investigational Site
Szczecin, 71-270, Poland
Lycera Investigational Site
Warsaw, 02-507, Poland
Lycera Investigational Site
Warsaw, 04-749, Poland
Lycera Investigational Site
Wroclaw, 50-449, Poland
Lycera Investigational Site
Wroclaw, 53-333, Poland
Lycera Investigational Site
Wroclaw, Poland
Lycera Investigational Site
Włocławek, 87-800, Poland
Lycera Investigational Site
Belgrade, 11000, Serbia
Lycera Investigational Site
Kragujevac, 34000, Serbia
Lycera Investigational Site
Niš, 18000, Serbia
Lycera Investigational Site
Subotica, 24000, Serbia
Lycera Investigational Site
Zrenjanin, 23000, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- H. Jeffrey Wilkins MD, Chief Medical Officer
- Organization
- Lycera Corp.
Study Officials
- STUDY DIRECTOR
H. Jeffrey Wilkins, MD
Lycera Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 6, 2016
Study Start
November 1, 2016
Primary Completion
July 18, 2018
Study Completion
July 18, 2018
Last Updated
March 27, 2019
Results First Posted
March 27, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share