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

Stopped early · Phase 2

Conditions studied: Colitis, Ulcerative

In brief

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

Key facts

Study ID

NCT02764229

Run by

Lycera Corp.

People needed

112

Starts

2016-11-01

Expected to finish

2018-07-18

Last updated by the study team

2019-03-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Lycera Investigational Site — Little Rock, Arkansas, United States
• Lycera Investigational Site — Mission Hills, California, United States
• Lycera Investigational Site — Miami, Florida, United States
• Lycera Investigational Site — Chicago, Illinois, United States
• Lycera Investigational Site — Ann Arbor, Michigan, United States
• Lycera investigational site — Greenville, North Carolina, United States
• Lycera Investigational Site — Nashville, Tennessee, United States
• Lycera Investigational Site — Houston, Texas, United States
• Lycera investigational site — San Antonio, Texas, United States
• Lycera Investigational Site — Ostrava, Czechia
• Lycera Investigational Site — Prague, Czechia
• Lycera Investigational Site — Ústí nad Labem, Czechia
• Lycera Investigational Site — Budapest, Hungary
• Lycera Investigational Site — Budapest, Hungary
• Lycera Investigational Site — Rotterdam, Netherlands
• 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 — Krakow, Poland
• Lycera Investigational Site — Lublin, Poland
• Lycera Investigational Site — Piaseczno, Poland
• Lycera Investigational Site — Poznan, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.