A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Ⅲ, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: IBI112
* Drug: placebo /IBI112
* Drug: IBI112


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment) Exclusion Criteria: History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis Has received any therapeutic agent directly targeted to IL-17within 6 months of the first administration of study agent Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent Has received any conventional therapeutic agent within 1 months of the first administration of study agent Has received any topic therapeutic agent within 2 weeks of the first administration of study agent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Participants receive placebo through week 16,placebo participants will cross over to receive IBI112 through week 48 | Drug: placebo /IBI112<br>* placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48<br>|
| Experimental: Group 2<br>Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 2 IBI112 through week 48 | Drug: IBI112<br>* IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48<br>|
| Experimental: Group 3<br>Participants receive Dose 1 IBI112 through week 16 ,and then will receive Dose 3 IBI112 through week 48 | Drug: IBI112<br>* IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |