Tests HSK47388 in adults with moderate to severe ulcerative colitis
Tests the drug HSK47388 against a placebo in adults with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study for HSK47388 in Participants With Ulcerative Colitis
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07335055, who can take part
Where in China
- Sir Run Run Shaw HospitalHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haisco Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07335055
- Record updated
- 5 March 2026
- Original description
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 .Read full original descriptionShow less
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
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 .
Inclusion: Written informed consent must be obtained; Male or female, ≥18 years old and ≤75 years old; Willing and able to comply with study-specific procedures and the requirements of study protocol; Diagnosis of ulcerative colitis (UC); Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3; Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy.
Exclusion: Subjects have used treatments within the time frame specified in protocol prior to the baseline visit; Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon; Intra-abdominal or other major surgery performed within 12 weeks before baseline; Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease; Presence or history of a fistula; History of extensive colonic resection; Concurrent conditions and history of other diseases as described in protocol; Subjects have laboratory values meeting the criteria in protocol; Presence of a stoma.