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NCT04840485 Clinical Trial

Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:
A Randomized, Double-blind, Multicenter, Placebo-controlled, Phase II/III Adaptive Study of SHR-1314 to Assess Efficacy and Safety in Patients With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04840485
Other study ID # SHR-1314-302
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 9, 2021
Est. completion date February 28, 2024

Study information
Verified date May 2024
Source Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis

Recruitment information / eligibility
Status Completed
Enrollment 548
Est. completion date February 28, 2024
Est. primary completion date November 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs Exclusion Criteria: - pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SHR-1314
SHR-1314 high dose
• SHR-1314
SHR-1314 low-dose
• Placebo
Placebo

Locations
Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks 16 Weeks
Secondary Percentage of Participants Responded for ASAS 20 Response at 32 Weeks 32 Weeks
Secondary Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks 16 and 32 Weeks
Secondary Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks 16 and 32 Weeks
Secondary Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks 16 and 32 Weeks
Secondary Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks 16 and 32 Weeks
See also
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