NCT06860750RecruitingPhase 3
A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- First submitted
- 2 Mar 2025
- Start date
- 29 Apr 2025
- Primary completion date
- Feb 2028
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06860750
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 380
- From 29 Apr 2025 to the primary completion date, Feb 2028
- 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
- Receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period.
- Blood donation of approximately 500 mL within 8 weeks before randomization, or plans to donate blood during the study period.
Other illness
- Subjects with active systemic infection or severe infection.
- Subjects with active tuberculosis or latent tuberculosis infection.
- Subjects with lymphoma or lymphoproliferative disease.
- Subjects with uncontrolled hypertension.
- Subjects with history of malignancy within the past 5 years or current malignancy.
- Subjects with moderate to severe congestive heart failure.
- Subjects with history of organ transplantation, or severe, progressive, or uncontrolled diseases of any organ system.
- known allergy to the study drug or any of its components.
- Subjects with history of alcohol abuse or illegal drug use within the past year.
Lab values
- Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG at the time of screening.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- Age ≥ 18 years at the time of signing the informed consent form, regardless of gender.
- BMI (Body Mass Index) ≥ 18 kg/m² at the time of screening.
- Presence of objective signs of inflammation at the time of screening.
- The subject voluntarily signs the ICF (informed consent form) before the start of any study-related procedures.
- The subject is able to communicate effectively with the investigator, understands and is willing to strictly adhere to the requirements of the clinical study protocol to complete the study.
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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.