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| Name | Class |
|---|---|
| Haisco-USA Pharmaceuticals, Inc. | INDUSTRY |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK47388-Dose level 1 | Experimental |
| |
| HSK47388-Dose level 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with clinical response | Week 12 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongrui Wang | Contact | 028-67258840 | wangyr@haisco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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. |
|
| 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 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |