To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

Study Overview
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Brief Summary
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This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.

Official Title
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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Psoriatic Arthritis Subjects

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: SHR0302 tablets、Placebo
* Drug: SHR0302 tablets、Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed informed consent； Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit； Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints； Diagnosis of active plaque psoriasis or documented history of plaque psoriasis. Exclusion Criteria: History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases； Non-plaque forms of psoriasis (with exception of nail psoriasis)； Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.

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
Interventional Model Description: SHR0302 tablets compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>SHR0302 tablets dose 1+ Placebo dose 2 | Drug: SHR0302 tablets、Placebo<br>* SHR0302 tablets dose 1 for 48 weeks<br>|
| Experimental: Treatment group B<br>SHR0302 tablets dose 2+ Placebo dose 1 | Drug: SHR0302 tablets、Placebo<br>* SHR0302 tablets dose 2 for 48 weeks<br>|
| Placebo Comparator: Treatment group C<br>Placebo dose1 + placebo dose 2 | Drug: Placebo<br>* SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response rate at week 24 | Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24 | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response rate at week 48 | Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 48 | Week 48 | 
| ACR50/70 response rate at week 24 and week 48 | Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 50%/70% (ACR50/70) at week 24 and week 48 | Week 24 and week48 | 
| Change from baseline in DAS28-CRP week 24 and week 48 | Change from baseline in the disease activity score-CRP(DAS 28-CRP) at week 24 and week 48 | Week 24 and week 48 |