Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06860750

A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-06-22

380

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.

CONDITIONS

Official Title

A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of signing informed consent, any gender
  • Body Mass Index (BMI) of 18 kg/m² or higher at screening
  • Presence of objective signs of inflammation at screening
  • Voluntarily signed informed consent form before any study procedures
  • Ability to communicate effectively and willingness to follow study protocol
Not Eligible

You will not qualify if you...

  • Active systemic or severe infection
  • Active tuberculosis or latent tuberculosis infection
  • Lymphoma or lymphoproliferative disease
  • Uncontrolled hypertension
  • History of malignancy within past 5 years or current malignancy
  • Moderate to severe congestive heart failure
  • History of organ transplantation or severe, progressive, uncontrolled diseases of any organ system
  • Abnormal laboratory tests or 12-lead ECG at screening as defined by protocol
  • Pregnant or breastfeeding women
  • Known allergy to study drug or its components
  • History of alcohol abuse or illegal drug use within past year
  • Receipt of live vaccine within 12 weeks before randomization or planned during study
  • Blood donation of about 500 mL within 8 weeks before randomization or planned during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100039

Actively Recruiting

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Research Team

L

Lihua Lin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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