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

Phase 2

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: SHR-1314; Drug: Placebo

• Registration Number: NCT04840485
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Study Start: 2021-06-09
• Primary Completion: 2023-11-03
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 548

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR-1314	-
Treatment group B	SHR-1314	-
Treatment group C	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks	16 and 32 Weeks
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 and 32 Weeks	16 and 32 Weeks
Percentage of Participants Responded for ASAS 20 Response at 32 Weeks	32 Weeks
Percentage of Participants Responded for ASAS 40 Response at 16 and 32 Weeks	16 and 32 Weeks
Percentage of Participants Responded for ASAS 5/6 Response at 16 and 32 Weeks	16 and 32 Weeks

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China