A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults

Study Overview
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Brief Summary
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This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults

Detailed Description
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This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.

Official Title
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Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Biological: IL-17A Antagonist
* Biological: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent before any study assessment is performed. Male or female at least 18 years of age at screening. Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis. Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy. The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening. Exclusion Criteria: Diagnosis of psoriasis at screening is not chronic plaque psoriasis Severe infection or systemic infection before baseline There are other skin problems that researchers believe will hinder the evaluation of psoriasis. Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis. The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study. Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents. There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive. Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis. Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis. Women who are pregnant or breastfeeding at screening or at baseline The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: Treatment group A<br>SHR-1314 low dose short intervals of subcutaneous injection | Biological: IL-17A Antagonist<br>* SHR-1314 subcutaneous injection<br>* Other names: SHR-1314;|
| Active Comparator: Treatment group B<br>SHR-1314 high dose long intervals of subcutaneous injection | Biological: IL-17A Antagonist<br>* SHR-1314 subcutaneous injection<br>* Other names: SHR-1314;Biological: Placebos<br>* placebo subcutaneous injection to maintain consistency and to prevent blindness<br>|
| Active Comparator: Treatment group C<br>SHR-1314 high dose short intervals of subcutaneous injection | Biological: IL-17A Antagonist<br>* SHR-1314 subcutaneous injection<br>* Other names: SHR-1314;Biological: Placebos<br>* placebo subcutaneous injection to maintain consistency and to prevent blindness<br>|
| Placebo Comparator: Placebo group<br>Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection | Biological: IL-17A Antagonist<br>* SHR-1314 subcutaneous injection<br>* Other names: SHR-1314;Biological: Placebos<br>* placebo subcutaneous injection to maintain consistency and to prevent blindness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects reach to PASI 75 response at 16 weeks | Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 16 | 16 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving PASI 90 response at week 16 | Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 90% (to achieve a PASI 90 response) relative to the baseline PASI score at Week 16 will be evaluated. | 16 week |