A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Non-Radiographic Axial Spondyloarthritis

Study Overview
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Brief Summary
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This study is to evaluate the efficacy and safety of SHR0302 in subjects with active non-radiographic axial spondyloarthritis.

Official Title
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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

Conditions
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Non-radiographic Axial Spondyloarthritis

Intervention / Treatment
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* Drug: SHR0302
* Drug: SHR0302 placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: SHR0302 compared with placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br>SHR0302 | Drug: SHR0302<br>* SHR0302, oral, once daily<br>|
| Placebo Comparator: Treatment group B<br>SHR0302 Placebo | Drug: SHR0302 placebo<br>* SHR0302 placebo, oral, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12 |  | Week 12 | 
| Percentage of Participants With ASAS 20 Response at week 12 |  | Week 12 | 
| Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 |  | Week 12 | 
| Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24 |  | Week 12 and Week 24 | 
| Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24 |  | Week 12 and Week 24 |