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

NCT05324631 | Unknown Phase 3

• 1 other identifier: SHR0302-305
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-radiographic Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 40 Response at week 12

  Week 12

Secondary Outcomes (8)

• 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

Study Arms (2)

Treatment group A

EXPERIMENTAL

SHR0302

Drug: SHR0302

Treatment group B

PLACEBO COMPARATOR

SHR0302 Placebo

Drug: SHR0302 placebo

Interventions

SHR0302 DRUG

SHR0302, oral, once daily

Treatment group A

SHR0302 placebo DRUG

SHR0302 placebo, oral, once daily

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Non-Radiographic Axial Spondyloarthritis

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Xuan Zhang

CONTACT

(+86)13436522766; zxlab@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR0302 compared with placebo

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 12, 2022
• Study Start: August 16, 2022
• Primary Completion: August 30, 2024
• Study Completion: December 11, 2024
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

CN (1)