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

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

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

Study Overview

• Status: Recruiting
• Conditions: Non-radiographic Axial Spondyloarthritis
• Intervention / Treatment: Drug: SHR0302; Drug: SHR0302 placebo

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xuan Zhang; Phone Number: (+86)13436522766; Email: zxlab@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Beijing Hospital
      • Contact: Xuan Zhang, Doctor; Phone Number: +86-13699268153; Email: zxlab@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group A; SHR0302	Drug: SHR0302; SHR0302, oral, once daily
PLACEBO_COMPARATOR: Treatment group B; SHR0302 Placebo	Drug: SHR0302 placebo; SHR0302 placebo, oral, once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2022
• Primary Completion (ANTICIPATED): August 30, 2024
• Study Completion (ANTICIPATED): December 11, 2024

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (ACTUAL): April 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Spondylitis; Spondylarthritis
• Other Study ID Numbers: SHR0302-305

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