RecruitingPhase 2NCT07335055

A Study for HSK47388 in Participants With Ulcerative Colitis

A Phase 2 Randomized, Double-blind, Placebo-Controlled, Multicenter Clinical Study to Evaluate the Efficacy and Safety of HSK47388 in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

150 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis (UC)

Summary

The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HSK47388 in adults with moderately active ulcerative colitis (an inflammatory bowel disease causing inflammation in the colon) who have not responded well to prior standard or advanced therapies. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with ulcerative colitis - Your colitis is moderately active (based on a standard scoring tool) - Prior treatments — such as mesalamine, steroids, immunosuppressants, or biologics — have not worked well or have caused side effects **You may NOT be eligible if...** - You have Crohn's disease or another type of colitis (ischemic, indeterminate) - You have ever had a colostomy/ileostomy bag - You have had major abdominal surgery in the past 12 weeks - Your lab values do not meet study requirements - You have had toxic megacolon or fulminant colitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK47388

Participants will be randomized to receive HSK47388, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.

DRUGPlacebo

Participants will be randomized to receive Placebo, orally starting at Week 0 . At Week-12, all participants will be evaluated for clinical response and responders will enter the maintenance study.