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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 .
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Sir Run Run Shaw Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Yongrui Wang
wangyr@haisco.com
028-67258840
Time Frame
Start Date: 2026-02-03
Estimated Completion Date: 2029-02-02
Participants
Target number of participants: 150
Treatments
Experimental: HSK47388-Dose level 1
Experimental: HSK47388-Dose level 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Haisco Pharmaceutical Group Co., Ltd.
Collaborators: Haisco-USA Pharmaceuticals, Inc.