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

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04957550
• Other study ID #: SHR0302-303
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: August 30, 2021
• Est. completion date: November 13, 2024

Study information

• Verified date: February 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 444
• Est. completion date: November 13, 2024
• Est. primary completion date: November 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Peking University Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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