RecruitingPhase 2

A Study for HSK47388 in Participants With Ulcerative Colitis

China150 participantsStarted 2026-02-03

Plain-language 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 .

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Subjects have used treatments within the time frame specified in protocol prior to the baseline visit
✕. Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease
✕. Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon
✕. Presence of a stoma
✕. Presence or history of a fistula
✕. Intra-abdominal or other major surgery performed within 12 weeks before baseline
✕. History of extensive colonic resection
✕. Subjects have laboratory values meeting the criteria in protocol

What they're measuring

The proportion of patients with clinical response

Timeframe: Week 12

Trial details

NCT IDNCT07335055

SponsorHaisco Pharmaceutical Group Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-15

Contact for this trial

Yongrui Wang

028-67258840 wangyr@haisco.com

View on ClinicalTrials.gov More Ulcerative Colitis (UC) trials