A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics

Study Overview
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Brief Summary
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This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.

Official Title
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A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: regular treatment
* Drug: Intensive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years old; Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator; Received previous biologic therapy with at least 4 months. Exclusion Criteria: Previously or currently diagnosed with pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.); Or presenting with guttate psoriasis at screening or first dose administration; Previously treated with IBI112 or other IL-23 inhibitors; Treated with two biologics for psoriasis within 4 months prior to screening; Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration; Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration; Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study; Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Response to previous biologic therapy<br>Participants with sPGA0 or 1 score and the body surface area affected with psoriasis lesions <3% at baseline; or PASI-75 was achieved after treated with the previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 12, 24 and 36. | Drug: regular treatment<br>* IBI112 200mg s.c. at week 0, 12, 24 and 36.<br>* Other names: Response to previous biologic therapy;|
| Experimental: Poor response to previous biologic therapy<br>Participants with sPGA score ≥2 at baseline, or body surface area affected with psoriasis lesions ≥3% at baseline, o PASI-75 was not reached after treated with previous biologics. 200mg of IBI112 will be administered subcutaneously at week 0, 4, 8, 20 and 32. | Drug: Intensive treatment<br>* IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.<br>* Other names: Poor response to previous biologic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve sPGA clean (0) or nearly clean (1) at week 16. |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieve sPGA clean (0) at Week 16. |  | Week 16 | 
| Percentage of participants with a DLQI score of 0/1 at Week 16. |  | Week 16 | 
| Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44. |  | Week 44 | 
| Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44 |  | Week 16 up to Week 44 |