A Study for HSK47388 in Participants With Ulcerative Colitis
NCT ID: NCT07335055
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2026-01-29
2029-02-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HSK47388-Dose level 1
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.
HSK47388-Dose level 2
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.
Placebo
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Haisco-USA Pharmaceuticals, Inc.
INDUSTRY
Haisco Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sir Run Run Shaw Hospital
Hangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSK47388-202
Identifier Type: -
Identifier Source: org_study_id
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