SHR0302 tablets、Placebo: SHR0302 tablets dose 1 for 48 weeks
SHR0302 tablets、Placebo: SHR0302 tablets dose 2 for 48 weeks
Placebo: SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Provide signed informed consent；
2. Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit；
3. Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints；
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Exclusion Criteria:
1. History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases；
2. Non-plaque forms of psoriasis (with exception of nail psoriasis)；
3. Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.
Primary outcome measure(s)
ACR20 response rate at week 24 — Week 24 Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24
Trial sites (1)
Facility
City
Region
Status
Peking University Hospital
Beijing
Beijing Municipality
More Jiangsu HengRui Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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