Phase 2 Study to Test the Safety and Effectiveness of HSK47388 for Moderate to Severe Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the efficacy and safety of HSK47388 in adults aged 18 to 75 years who have moderately to severely active ulcerative colitis. This phase 2 randomized, double-blind, placebo-controlled clinical trial seeks to determine how well HSK47388 works as a treatment compared to placebo in this condition. Participants must have a baseline modified Mayo score between 5 and 9 and an endoscopy subscore of 2 to 3, with prior inadequate response or intolerance to conventional or advanced therapies. Participants will be randomly assigned to one of three groups two different dose levels of HSK47388 or a placebo. Treatment begins orally at Week 0 and continues through Week 12. At Week 12, all participants will be evaluated for clinical response, and those who respond may continue in a maintenance study. The study design includes careful monitoring during this initial 12-week treatment period. During the trial, participants will undergo assessments to measure clinical response, remission, and symptom improvement using tools such as the Mayo score and endoscopic evaluation. Researchers will collect data at Week 12 to determine the proportion of patients achieving clinical response and remission. Safety and adherence to study procedures will be monitored throughout. The total study duration and follow-up extend up to the end date in 2029, allowing for comprehensive evaluation.

A Study for HSK47388 in Participants With Ulcerative Colitis