Actively Recruiting
A Study for HSK47388 in Participants With Ulcerative Colitis
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-03-05
150
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Haisco Pharmaceutical Group Co., Ltd.
Lead Sponsor
H
Haisco-USA Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official Title
A Study for HSK47388 in Participants With Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sir Run Run Shaw Hospital
Hangzhou, China
Actively Recruiting
Research Team
Y
Yongrui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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