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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.548 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

548

Conditions

Ankylosing Spondylitis

Interventions

SHR-1314DRUG

SHR-1314 high dose

SHR-1314DRUG

SHR-1314 low-dose

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks

Time frame: 16 Weeks

Secondary Outcomes

Percentage of Participants Responded for ASAS 20 Response at 32 Weeks

Time frame: 32 Weeks

Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks

Time frame: 16 and 32 Weeks

Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks

Time frame: 16 and 32 Weeks

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks

Time frame: 16 and 32 Weeks

Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks

Time frame: 16 and 32 Weeks

Data from ClinicalTrials.gov

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