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

Phase 3

• Conditions: Psoriatic Arthritis
• Interventions: Drug: SHR0302 tablets、Placebo; Drug: Placebo

• Registration Number: NCT04957550
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-12
• Study Start: 2021-08-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-11-13
• Study Completion: 2024-11-13

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 444

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR0302 tablets、Placebo	SHR0302 tablets dose 1+ Placebo dose 2
Treatment group B	SHR0302 tablets、Placebo	SHR0302 tablets dose 2+ Placebo dose 1
Treatment group C	Placebo	Placebo dose1 + placebo dose 2

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Hospital; 🇨🇳 Beijing, Beijing, China