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

• Status: Recruiting
• Trial end date: 2024-11-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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.