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

Inclusion Criteria6

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 Criteria9

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
Concurrent conditions and history of other diseases as described in protocol

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.