A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis
Primary Purpose
Non-radiographic Axial Spondyloarthritis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR0302
SHR0302 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-radiographic Axial Spondyloarthritis
Eligibility Criteria
Inclusion Criteria:
- Provide signed informed consent.
- BMI ≥18 kg/m2.
- Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).
- Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
- Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
- 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.
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 1.5 times the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
Sites / Locations
- Beijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group A
Treatment group B
Arm Description
SHR0302
SHR0302 Placebo
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
Secondary Outcome Measures
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12
Percentage of Participants With ASAS 20 Response at week 12
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12
Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24
Full Information
NCT ID
NCT05324631
First Posted
April 6, 2022
Last Updated
September 1, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05324631
Brief Title
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Non-Radiographic Axial Spondyloarthritis Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
December 11, 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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-radiographic Axial Spondyloarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR0302 compared with placebo
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Description
SHR0302
Arm Title
Treatment group B
Arm Type
Placebo Comparator
Arm Description
SHR0302 Placebo
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
SHR0302, oral, once daily
Intervention Type
Drug
Intervention Name(s)
SHR0302 placebo
Intervention Description
SHR0302 placebo, oral, once daily
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12
Time Frame
Week 12
Title
Percentage of Participants With ASAS 20 Response at week 12
Time Frame
Week 12
Title
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12
Time Frame
Week 12
Title
Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24
Time Frame
Week 12 and Week 24
Title
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24
Time Frame
Week 12 and Week 24
Title
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24
Time Frame
Week 12 and Week 24
Title
Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24
Time Frame
Week 12 and Week 24
Title
Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24
Time Frame
Week 12 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide signed informed consent.
BMI ≥18 kg/m2.
Participant has the clinical diagnosis of nr-axSpA fulfilling the 2009 ASAS classification criteria for axSpA but not meeting the radiologic criterion of the modified New York criteria for AS and have objective signs of active inflammation on magnetic resonance imaging (MRI) or based on high sensitivity C-reactive protein (CRP).
Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
Participant has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
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.
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 1.5 times the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Zhang
Phone
(+86)13436522766
Email
zxlab@outlook.com
Facility Information:
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Zhang, Doctor
Phone
+86-13699268153
Email
zxlab@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis
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