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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02764229 |
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Date of registration:
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04/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
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Scientific title:
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A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis |
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Date of first enrolment:
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November 1, 2016 |
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Target sample size:
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112 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02764229 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Czechia
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Hungary
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Netherlands
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Poland
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Serbia
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United States
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Contacts
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Name:
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H. Jeffrey Wilkins, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lycera Corp. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colitis, Ulcerative
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Intervention(s)
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Drug: LYC-30937-EC
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Primary Outcome(s)
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Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment
[Time Frame: 46 weeks]
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Secondary ID(s)
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LYC-30937-2002
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2016-003633-26
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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