A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

November 21, 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 Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

566

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 Contact

Study Contact Backup

Study Locations

  • China
    • Guangxi
      • Liuzhou, Guangxi, China
        • Liuzhou Workers' 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

Description

Inclusion Criteria:

  • Provide signed informed consent.
  • RA diagnosis consistent with the 2010 ACR/EULAR criteria;
  • Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
  • Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
  • If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
  • BMI ≥18 kg/m2

Exclusion Criteria:

  • Pregnant women or refuse to receive contraception during the study.
  • Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
  • History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
  • Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
Experimental: SHR0302 dose1
Drug: SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
Experimental: SHR0302 dose2
Drug: SHR0302
The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 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
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR20 response rate at week 52
Time Frame: Week 52
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 52
Week 52
ACR50 response rate at week 24 and week 52
Time Frame: Week 24 and week 52
Response rate of 50% improvement in American College of Rheumatology (ACR50) criteria at week 24 and week 52
Week 24 and week 52
ACR70 response rate at week 24 and week 52
Time Frame: Week 24 and week 52
Response rate of 70% improvement in American College of Rheumatology (ACR70) criteria at week 24 and week 52
Week 24 and week 52
Change from baseline in HAQ-DI score at week 24 and week 52
Time Frame: Week 24 and week 52
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24 and week 52
Week 24 and week 52
Change from baseline in SF-36 score at week 24 and week 52
Time Frame: Week 24 and week 52
Change from baseline in the medical outcomes study 36-Item Short-Form Health Survey (SF-36) score at week 24 and week 52
Week 24 and week 52
DAS28-CRP <2.6 proportion at week 24 and week 52
Time Frame: Week 24 and week 52
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of less than 2.6
Week 24 and week 52
DAS28-CRP≤3.2 proportion at week 24 and week 52
Time Frame: Week 24 and week 52
Disease Activity Score for 28-joint counts based on the c-reaction protein (DAS28-CRP) of equal to and less than 3.2
Week 24 and week 52

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)

July 31, 2020

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

September 21, 2023

Study Registration Dates

First Submitted

April 2, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR0302-301

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

product manufactured in and exported from the U.S.

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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