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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT07302360
Eligibility Criteria:
Inclusion criteria:
* Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\>=) 2; c) Mayo rectal bleeding subscore (RBS) \>= 1 at baseline
* Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
* Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
* Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements
Exclusion criteria:
* Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
* Contraindicated to guselkumab per the label
* Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
* Participants who will be receiving guselkumab therapy combined with a second advanced therapy
* Participants with a history of colectomy and/or pouch
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07302360
Study Brief:
Protocol Section:
NCT07302360