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

February 7, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

444

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 200433
        • Peking University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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
Drug: SHR0302 tablets、Placebo
SHR0302 tablets dose 2 for 48 weeks
EXPERIMENTAL: Treatment group B
SHR0302 tablets dose 2+ Placebo dose 1
Drug: SHR0302 tablets、Placebo
SHR0302 tablets dose 1 for 48 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 48
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
Week 24 and week48
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
Week 24 and week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2021

Primary Completion (ANTICIPATED)

November 13, 2024

Study Completion (ANTICIPATED)

November 13, 2024

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (ACTUAL)

July 12, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR0302-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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