Safety and Effectiveness Study of INT-210 Capsules in Adults With Active Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes INT-210 capsules in adults with active ulcerative colitis UC. This randomized, open-label study focuses on participants aged 18 to 75 years diagnosed with active UC, aiming to gather detailed information on the drugs pharmacokinetics and pharmacodynamics while monitoring treatment safety. Participants will receive oral INT-210 capsules in one of two doses 200 mg twice daily or 400 mg twice daily, starting from Day 1 of a 12-week treatment period. The study is designed to compare these two dosing regimens in parallel groups to assess their impact on UC symptoms and drug behavior in the body. During the study, participants will undergo various assessments including laboratory tests to monitor safety, clinical evaluations to measure remission and response rates, and pharmacokinetic sampling up to Day 85. Safety follow-up continues through Day 92 to track adverse events and important clinical parameters. Overall, participants can expect regular visits and monitoring throughout the treatment and follow-up phases lasting approximately 3 months.

A Phase Ib/IIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis