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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840485
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study Description
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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

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: SHR-1314 Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 529 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : March 15, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group A Drug: SHR-1314
SHR-1314 high dose
Experimental: Treatment group B Drug: SHR-1314
SHR-1314 low-dose
Placebo Comparator: Treatment group C Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Responded for Assessment of SpondyloArthritis international Society 20 Criteria (ASAS20) at 16 Weeks [ Time Frame: 16 Weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840485


Contacts
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Contact: Yirong Zhao 0518-82342973 Yirong.zhao@hengrui.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Principal Investigator: Feng Huang, Doctor         
Sponsors and Collaborators
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
More Information
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Responsible Party: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04840485    
Other Study ID Numbers: SHR-1314-302
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
 Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis