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

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 .

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (UC)
• Intervention / Treatment: Drug: HSK47388; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yongrui Wang; Phone Number: 028-67258840; Email: wangyr@haisco.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Sir Run Run Shaw Hospital
    • Principal Investigator: Qian Cao
    • Contact: Xu; Phone Number: 0571-86006811; Email: xm@srrsh.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 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.
Experimental: HSK47388-Dose level 1	Drug: 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.
Experimental: HSK47388-Dose level 2	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with clinical response	Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with clinical remission	Week 12
The proportion of patients with symptomatic remission	Week 12
The proportion of patients with endoscopic remission	Week 12
Proportion of patients with Mayo endoscopic subscore 0	Week 12
Percent change from baseline in Mayo score and modified Mayo score	Week 12
Percent change from baseline in partial Mayo score	Week 12

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.
• Collaborators: Haisco-USA Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): February 2, 2029

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: HSK47388-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No