NCT04840485CompletedPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 22 May 2024
Brief summary (registry, in English)
The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 548 (actual)
- First submitted
- 7 Apr 2021
- Start date
- 9 Jun 2021
- Primary completion date
- 3 Nov 2023
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT04840485
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 548
- From 9 Jun 2021 to the primary completion date, 3 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
Who the study is looking for
- \- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.