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The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 3 | Experimental | Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44 |
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| Group 4 | Experimental | Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44 |
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| Group 6 | Experimental | Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44 |
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| Group 5 | Placebo Comparator | Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44 |
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| Group 1 | Experimental | Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 |
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| Group 2 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI112 | Drug | Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response | Week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with a PASI75 Response | Week 56 | |
| Percentage of participants with a PASI100 Response | Week 56 | |
| Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | 200443 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Participant, Care Provider, Investigator
Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44
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| IBI112/placebo | Drug | Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection |
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| IBI112/placebo | Drug | Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44 |
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| IBI112 | Drug | Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44 |
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| IBI112 | Drug | Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44 |
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| IBI112 | Drug | Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection |
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| Week 56 |
| Percentage of participants with Dermatology Life Quality Index (DLQI) Score | Week 56 |
| Percentage of participants with a sIGA score of 0 | Week 56 |
| Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response | Week 56 |
| Changes of PASI Scores participants who relapse and retreatment | Week 56 |
| Changes of sIGA score in participants who relapse and retreatment | Week 56 |