At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 548 enrolled
Drug / intervention
SHR-1314 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Suzhou Suncadia Biopharmaceuticals Co., Ltd.·interventional·Posted Apr 12, 2021·Updated May 22, 2024
In Brief
A Phase 3 clinical trial evaluating SHR-1314 and Placebo for Ankylosing Spondylitis. Completed, enrolled 548 participants across 1 site.
Detailed Summary
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartJun 2021
Primary CompletionNov 2023
Study CompletionFeb 2024
TodayJul 2026
First PostedApr 12, 2021
Enrollment StartJun 9, 2021
Primary CompletionNov 3, 2023
Study CompletionFeb 28, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.2 years ago
Interventions
SHR-1314drug
SHR-1314 high dose
SHR-1314drug
SHR-1314 low-dose
Placebodrug
Placebo