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The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI112 dose 1 | Experimental | Participants will receive IBI112 dose 1 subcutaneous injection(SC) |
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| IBI112 dose 4 | Experimental | Participants will receive IBI112 dose 4 subcutaneous injection(SC) |
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| IBI112 dose 2 | Experimental | Participants will receive IBI112 dose 2 subcutaneous injection(SC) |
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| IBI112 dose 3 | Experimental | Participants will receive IBI112 dose 3 subcutaneous injection(SC) |
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| Placebo | Placebo Comparator | Participants will receive placebo subcutaneous injection(SC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI112 dose 2 | Drug | Participants will receive placebo or dose 2 IBI112 SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16 | PASI 90 is defined as at least a 90% reduction in PASI relative to baseline | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16 | PASI 75 is defined as at least a 75% reduction in PASI relative to baseline | Week 16 |
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16 |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PeKing University People's Hostpital | Beijing | Beijing Municipality | 100044 | 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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| IBI112 dose 4 |
| Drug |
Participants will receive placebo or dose 4 IBI112 SC |
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| IBI112 dose 1 | Drug | Participants will receive placebo or dose 1 IBI112 SC |
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| IBI112 dose 3 | Drug | Participants will receive placebo or dose 3 IBI112 SC |
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| placebo | Drug | Participants will receive placebo SC |
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PASI 100 is defined as at least a 100% reduction in PASI relative to baseline |
| Week 16 |
| Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe | Week 16 |
| Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe | Week 16 |
| Change from Baseline in Dermatology life quality index(DLQI) at week 16 | The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life | Week 16 |
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52 | PASI 90 is defined as at least a 90% reduction in PASI relative to baseline | Week 52 |
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52 | PASI 100 is defined as at least a 100% reduction in PASI relative to baseline | Week 52 |
| Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52 | PASI 75 is defined as at least a 75% reduction in PASI relative to baseline | Week 52 |
| Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe | Week 52 |
| Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52 | PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe | Week 52 |
| Change from Baseline in Dermatology life quality index(DLQI) at week 52 | The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life | Week 52 |