NCT07335055

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-02-03
• Primary completion: 2027-10-15
• Completion: 2029-02-02
• First posted: 2026-01-12
• Last updated: 2026-03-05

Locations

1 site across 1 country: China