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To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
This is a phase 2 randomized,double-blind, placebo-controlled study to evaluate the efficacy and safety of IBI112 induction and maintenance therapy in subjects with moderate to severe active ulcerative colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 2 IBI112 dose 4 | Experimental |
| |
| Period 1 IBI112 Placebo | Placebo Comparator |
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| Period 2 IBI112 dose 3 | Experimental |
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| Period 1 IBI112 dose 2 | Experimental |
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| Period 2 IBI112 Placebo | Placebo Comparator |
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| Period 1 IBI112 dose 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period 1 IBI112 Placebo | Drug | Intravenous Injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of IBI112 in inducing clinical remission in patients with moderately to severely active ulcerative colitis (UC) | Percentage of subjects who achieved clinical remission at week 12. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants achieving a clinical response at Week 12. | Clinical response is defined as a relative decrease from baseline in the modified Mayo score of ≥30% and ≥2 points, along with a relative decrease in the rectal bleeding subscore of ≥1 point or an absolute subscore of 0 or 1. | week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| Period 2 IBI112 dose 3 | Drug | Subcutaneous injections |
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| Period 1 IBI112 dose 1 | Drug | Intravenous Injection |
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| Period 1 IBI112 dose 2 | Drug | Intravenous Injection |
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| Period 2 IBI112 dose 4 | Drug | Intravenous Injection |
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| Period 2 IBI112 Placebo | Drug | Subcutaneous injections |
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| The proportion of participants achieving symptomatic relief at Week 12. |
Symptomatic relief is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. |
| week 12 |
| The proportion of participants achieving endoscopic remission at Week 12. | Endoscopic remission is defined as an endoscopic subscore of 0 or 1 within the modified Mayo score. | week 12 |
| The proportion of participants achieving mucosal healing at Week 12. | Mucosal healing is defined as endoscopic remission, which means an endoscopic subscore of 0 or 1 within the modified Mayo score, and central Geboes histopathological index remission. | week 12 |
| The proportion of participants achieving clinical remission at Week 52 during the maintenance treatment period. | week 52 |
| The proportion of participants achieving clinical response at Week 52 during the maintenance treatment period. | week 52 |
| The proportion of participants achieving symptomatic relief at Week 52 during the maintenance treatment period. | week 52 |
| The proportion of participants achieving mucosal healing at Week 52 during the maintenance treatment period. | week 52 |
| The proportion of participants achieving endoscopic remission at Week 52 during the maintenance treatment period. | week 52 |
| The change from baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period. | Week 12, Week 52,Weeks 24 and 64 |
| The change from baseline in the 36-item Short Form Health Survey (SF-36) scores at Week 12, Week 52 during the maintenance treatment period, and Weeks 24 and 64 during the extension treatment period. | Week 12, Week 52,Weeks 24 and 64 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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