This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active UC. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active UC due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 822 adult and 60 adolescent participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).

The goal of the DDRCC Biorepository is to collect human samples and health information to store for future research. Samples to be collected are blood, tissue (gastrointestinal, liver, pancreas and/or lymph nodes), stool, and cheek swabs. Participants may be eligible to enroll if scheduled for a clinical visit or surgical procedure during which these samples could be collected.

Efficacy of the vedolizumab IV and SC formulations has been demonstrated in completed studies of adult subjects with moderately to severely active UC or CD. Clinical trial results are needed to affirm proper dosing, exposure, efficacy and safety for use of vedolizumab in pediatric patients. Subsequent to preliminary positive results from the completed pediatric phase 2, vedolizumab IV is being further evaluated in the phase 3 Studies MLN0002-3024 and MLN0002-3025 (subjects aged 2 to 17 years). Confirmatory positive results from these studies would support submission for registration of vedolizumab IV for pediatric patients. Vedolizumab SC is being evaluated in the proposed study to provide an alternative administration route of vedolizumab for maintenance treatment in the
same pediatric population

The goal is to evaluate how well etrasimod helps reduce symptoms by week 12 of treatment. This involves determining whether patients experience enough improvement to be considered in remission. The focus is on how the medication performs in everyday, real-world conditions.