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

• ClinicalTrials.gov Identifier: NCT04333771
• Recruitment Status: Recruiting
• First Posted: April 3, 2020
• Last Update Posted: September 18, 2020
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: SHR0302; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• 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 Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.
• Actual Study Start Date: July 31, 2020
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Yang Shen, M.D; +86 021-61053363; shenyang@hrglobe.cn

Contact: Ying Yang; yangying@hrglobe.cn

Locations

China, Guangxi

Liuzhou workers' Hospital; Recruiting

Liuzhou, Guangxi, China

Principal Investigator: Xinghui Song

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

More Information

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04333771
• Other Study ID Numbers: SHR0302-301
• First Posted: April 3, 2020
• Last Update Posted: September 18, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases