A Study for HSK47388 in Participants With Ulcerative Colitis

NCT07335055 | Recruiting Phase 2

• 1 other identifier: HSK47388-202
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with clinical response

  Week 12

Secondary Outcomes (6)

• 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

Study Arms (3)

HSK47388-Dose level 1

EXPERIMENTAL

Drug: HSK47388

HSK47388-Dose level 2

EXPERIMENTAL

Drug: HSK47388

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

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.

Placebo

HSK47388 DRUG

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.

HSK47388-Dose level 1; HSK47388-Dose level 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead
• Haisco-USA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Yongrui Wang

CONTACT

028-67258840; wangyr@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 12, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): February 2, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CN (1)