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Completed

NCT Number: NCT04840485

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-1314

Drug

SHR-1314 high dose

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 16 Weeks

Secondary outcomes

  1. Percentage of Participants Responded for ASAS 20 Response at 32 Weeks

    Time frame: 32 Weeks

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

    Time frame: 16 and 32 Weeks

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

    Time frame: 16 and 32 Weeks

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

    Time frame: 16 and 32 Weeks

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

    Time frame: 16 and 32 Weeks

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 12, 2021
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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