IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

Study Overview
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Brief Summary
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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

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.

Conditions
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Psoriasis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of plaque-type psoriasis for at least 6 months; Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area; Must be a candidate for either systemic therapy or phototherapy for psoriasis. Exclusion Criteria: Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments Participants who have ever received IBI112 or IL-23 inhibitor History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 3<br>Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44 | Drug: IBI112<br>* Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44<br>|
| Experimental: Group 4<br>Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44 | Drug: IBI112<br>* Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 through week 44<br>|
| Experimental: Group 6<br>Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44 | Drug: IBI112<br>* Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & Dose 1 IBI112 through week 44<br>|
| Placebo Comparator: Group 5<br>Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44 | Drug: IBI112/placebo<br>* Participants receive Dose 1 IBI112 through week 8 & Dose 3 IBI112 on week 20 & placebo through week 44<br>|
| Experimental: Group 1<br>Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 | Drug: IBI112<br>* Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 through week 44 by subcutaneous injection<br>|
| Placebo Comparator: Group 2<br>Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 | Drug: IBI112/placebo<br>* Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response |  | Week 56 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |