Actively Recruiting
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
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-03-05
150
Participants Needed
1
Research Sites
68 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
Researchers are evaluating the efficacy and safety of HSK47388 in adults aged 18 to 75 years who have moderately to severely active ulcerative colitis. This phase 2 randomized, double-blind, placebo-controlled clinical trial seeks to determine how well HSK47388 works as a treatment compared to placebo in this condition. Participants must have a baseline modified Mayo score between 5 and 9 and an endoscopy subscore of 2 to 3, with prior inadequate response or intolerance to conventional or advanced therapies. Participants will be randomly assigned to one of three groups: two different dose levels of HSK47388 or a placebo. Treatment begins orally at Week 0 and continues through Week 12. At Week 12, all participants will be evaluated for clinical response, and those who respond may continue in a maintenance study. The study design includes careful monitoring during this initial 12-week treatment period. During the trial, participants will undergo assessments to measure clinical response, remission, and symptom improvement using tools such as the Mayo score and endoscopic evaluation. Researchers will collect data at Week 12 to determine the proportion of patients achieving clinical response and remission. Safety and adherence to study procedures will be monitored throughout. The total study duration and follow-up extend up to the end date in 2029, allowing for comprehensive evaluation.
CONDITIONS
Brief 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...
- Use of 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
- 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
- Laboratory values meeting exclusion criteria in protocol
- Concurrent conditions and history of other diseases as described in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants are randomized to receive either HSK47388 or placebo orally starting at Week 0 and continue treatment for 12 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Sir Run Run Shaw Hospital
Hangzhou, China
Actively Recruiting
Research Team
Y
Yongrui Wang
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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