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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Active Non-radiographic Axial Spondyloarthritis

In brief

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

Key facts

Study ID

NCT06860750

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

380

Starts

2025-04-29

Expected to finish

2028-12-01

Last updated by the study team

2025-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG at the time of screening.
• Pregnant or breastfeeding women.
• 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.
• 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.

Where it is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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