Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT04706793
Eligibility Criteria:
Inclusion Criteria:
Participants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following:
* Must have completed the Week 12 visit of Study APD334-302
* Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant \< 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants \< 20 years should be conducted only if acceptable according to local laws and regulations.
* Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists
Exclusion Criteria:
Participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study:
* If the Investigator considers the participant to be unsuitable for any reason to participate in the study
* Participants requiring partial or total colectomy during the APD334-302 study
* Participants requiring treatment with prohibited concomitant medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT04706793
Study Brief:
Protocol Section:
NCT04706793