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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04957550

Enrollment

418

Registered

2021-07-12

Start date

2021-08-30

Completion date

2026-12-13

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

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.

Interventions

DRUGSHR0302 tablets、Placebo

SHR0302 tablets dose 1 for 48 weeks

DRUGPlacebo

SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

SHR0302 tablets compared with placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026