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

Non-radiographic Axial Spondyloarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324631
• Other study ID #: SHR0302-305
• Status: Recruiting
• Phase: Phase 3
• Start date: August 16, 2022
• Est. completion date: December 11, 2024

Study information

• Verified date: September 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Xuan Zhang
• Phone: (+86)13436522766
• Email: zxlab[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 11, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Provide signed informed consent.

2. BMI =18 kg/m2.

3. 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).

4. 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.

5. 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.

6. 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:

1. Pregnant women or refuse to receive contraception during the study.

2. 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.

3. History of other autoimmune diseases ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.

Related Conditions & MeSH terms

• Non-radiographic Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• SHR0302
SHR0302, oral, once daily
• SHR0302 placebo
SHR0302 placebo, oral, once daily

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12		Week 12
Secondary	Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 12		Week 12
Secondary	Percentage of Participants With ASAS 20 Response at week 12		Week 12
Secondary	Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12		Week 12
Secondary	Percentage of Participants with ASAS 5/6 response at Week 12 and Week 24		Week 12 and Week 24
Secondary	Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 and Week 24		Week 12 and Week 24
Secondary	Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 and Week 24		Week 12 and Week 24
Secondary	Change from baseline in Short-Form-36-Health Survey (SF-36) at Week 12 and Week 24		Week 12 and Week 24
Secondary	Change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 12 and Week 24		Week 12 and Week 24