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OpenTrials
Active, not recruiting

NCT Number: NCT04957550

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Hospital

Beijing, Beijing Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide signed informed consent；
  • Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit；
  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints；
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

Exclusion criteria

  • History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases；
  • Non-plaque forms of psoriasis (with exception of nail psoriasis)；
  • Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.

Treatment and study plan

SHR0302 tablets、Placebo

Drug

SHR0302 tablets dose 1 for 48 weeks

Placebo

Drug

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

Primary outcomes

  1. ACR20 response rate at week 24

    Time frame: Week 24

    Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24

Secondary outcomes

  1. ACR20 response rate at week 48

    Time frame: Week 48

    Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 48

  2. ACR50/70 response rate at week 24 and week 48

    Time frame: 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

  3. Change from baseline in DAS28-CRP week 24 and week 48

    Time frame: Week 24 and week 48

    Change from baseline in the disease activity score-CRP(DAS 28-CRP) at week 24 and week 48

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 12, 2021
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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