Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis

Study Overview
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Brief Summary
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This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.

Official Title
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A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: SHR-1314 injection
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject voluntarily signs an informed consent form before any procedures related to the research start; Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender; At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR); There is active PsA before randomization; Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis; Exclusion Criteria: Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.

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 |
| --- | --- |
| Experimental: SHR-1314 injection<br> | Drug: SHR-1314 injection<br>* SHR-1314 injection<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving ACR 20 improvement at week 12 |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who achieved ACR 50 improvement (week 12) |  | week 12 | 
| The proportion of subjects who achieved ACR 70 improvement (week 12) |  | week 12 |