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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04840485

Enrollment

548

Registered

2021-04-12

Start date

2021-06-09

Completion date

2024-02-28

Last updated

2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

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

Interventions

DRUGSHR-1314

SHR-1314 high dose

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 and 32 Weeks	16 and 32 Weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 10, 2026