Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
Primary Purpose
Ankylosing Spondylitis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-1314
SHR-1314
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility Criteria
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
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment group A
Treatment group B
Treatment group C
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
Secondary Outcome Measures
Percentage of Participants Responded for ASAS 20 Response at 32 Weeks
Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks
Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks
Full Information
NCT ID
NCT04840485
First Posted
April 7, 2021
Last Updated
June 22, 2021
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04840485
Brief Title
Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
529 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Experimental
Arm Title
Treatment group C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1314
Intervention Description
SHR-1314 high dose
Intervention Type
Drug
Intervention Name(s)
SHR-1314
Intervention Description
SHR-1314 low-dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Responded for ASAS 20 Response at 32 Weeks
Time Frame
32 Weeks
Title
Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks
Time Frame
16 and 32 Weeks
Title
Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks
Time Frame
16 and 32 Weeks
Title
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks
Time Frame
16 and 32 Weeks
Title
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks
Time Frame
16 and 32 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yirong Zhao
Phone
0518-82342973
Email
Yirong.zhao@hengrui.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Huang, Doctor
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis
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