🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07335055
Recruiting Phase 2

A Study for HSK47388 in Participants With Ulcerative Colitis

NCT07335055 · tracked via the Priya Life Science China tracker
Sponsor
Haisco Pharmaceutical Group Co., Ltd.
Phase
Phase 2
Started
2026-02-03
Last updated
2026-03-05

Condition(s) studied

Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

HSK47388Placebo

HSK47388: 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.

Placebo: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent must be obtained 2. Male or female, ≥18 years old and ≤75 years old 3. Willing and able to comply with study-specific procedures and the requirements of study protocol. 4. Diagnosis of ulcerative colitis (UC) 5. Baseline modified Mayo score of 5 to 9 and the endoscopy subscore 2 to 3 6. Demonstrated an inadequate response, loss of response, or failure to tolerate previous conventional therapy or advanced therapy. Exclusion Criteria: 1. Subjects have used treatments within the time frame specified in protocol prior to the baseline visit 2. Diagnosis of indeterminate colitis, ischemic colitis, Crohn's colitis or clinical findings suggestive of Crohn's disease 3. Participants with current or prior diagnosis of fulminant colitis and/or toxic megacolon 4. Presence of a stoma 5. Presence or history of a fistula 6. Intra-abdominal or other major surgery performed within 12 weeks before baseline 7. History of extensive colonic resection 8. Subjects have laboratory values meeting the criteria in protocol 9. Concurrent conditions and history of other diseases as described in protocol

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sir Run Run Shaw Hospital Hangzhou China Recruiting

More Haisco Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335055 on ClinicalTrials.gov ↗ ← All trials in China