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

Primary Purpose

Psoriatic Arthritis

Status

Enrolling by invitation

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

SHR0302 tablets、Placebo

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Peking University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Treatment group C

Arm Description

SHR0302 tablets dose 1+ Placebo dose 2

SHR0302 tablets dose 2+ Placebo dose 1

Placebo dose1 + placebo dose 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT04957550

First Posted

July 5, 2021

Last Updated

February 7, 2023

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04957550

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

August 30, 2021 (Actual)

Primary Completion Date

November 13, 2024 (Anticipated)

Study Completion Date

November 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

SHR0302 tablets compared with placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

444 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group A

Arm Type

Experimental

Arm Description

SHR0302 tablets dose 1+ Placebo dose 2

Arm Title

Treatment group B

Arm Type

Experimental

Arm Description

SHR0302 tablets dose 2+ Placebo dose 1

Arm Title

Treatment group C

Arm Type

Placebo Comparator

Arm Description

Placebo dose1 + placebo dose 2

Intervention Type

Drug

Intervention Name(s)

SHR0302 tablets、Placebo

Intervention Description

SHR0302 tablets dose 1 for 48 weeks

Intervention Type

Drug

Intervention Name(s)

SHR0302 tablets、Placebo

Intervention Description

SHR0302 tablets dose 2 for 48 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

ACR20 response rate at week 24

Description

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

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

ACR20 response rate at week 48

Description

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

Time Frame

Week 48

Title

ACR50/70 response rate at week 24 and week 48

Description

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

Time Frame

Week 24 and week48

Title

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

Description

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

Time Frame

Week 24 and week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Peking University Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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