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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04957550
Recruitment Status : Enrolling by invitation
First Posted : July 12, 2021
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: SHR0302 tablets、Placebo Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 444 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: SHR0302 tablets compared with placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : November 13, 2024
Estimated Study Completion Date : November 13, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group A
SHR0302 tablets dose 1+ Placebo dose 2
 Drug: SHR0302 tablets、Placebo
SHR0302 tablets dose 1 for 48 weeks
Experimental: Treatment group B
SHR0302 tablets dose 2+ Placebo dose 1
 Drug: SHR0302 tablets、Placebo
SHR0302 tablets dose 2 for 48 weeks
Placebo Comparator: Treatment group C
Placebo dose1 + placebo dose 2
 Drug: Placebo
SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04957550


Locations
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China, Beijing
Peking University Hospital
Beijing, Beijing, China, 200433
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04957550    
Other Study ID Numbers: SHR0302-303
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
 Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases