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:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT03950232
Eligibility Criteria:
Inclusion Criteria:
* Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:
1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit
2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit
Exclusion Criteria:
* If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study
* Experienced an adverse event that led to discontinuation from parent study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
80 Years
Study:
NCT03950232
Study Brief:
Protocol Section:
NCT03950232