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The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of participants with moderate to severe plaque-type psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48 |
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| Group 2 | Experimental | Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48 |
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| Group 3 | Experimental | Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI112 | Drug | IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48 |
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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 |
| Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe | 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 |
|---|---|---|---|---|---|---|
| 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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| placebo /IBI112 | Drug | placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48 |
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| IBI112 | Drug | IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48 |
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PASI 100 is defined as at least a 100% reduction in PASI relative to baseline |
| Week 16 |
| Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe | 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 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 an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52 | sPGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. sPGA 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 |