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

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Mar 2, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called SHR-1314 injection for adults with active non-radiographic axial spondyloarthritis, a type of inflammatory arthritis that affects the spine and can cause pain and stiffness, even though it doesn't show up on regular X-rays. The study aims to see how effective and safe this injection is for managing the symptoms of this condition.

To participate in the trial, individuals must be at least 18 years old and have specific signs of inflammation. They should also be willing to follow the study's guidelines and communicate effectively with the research team. However, there are certain conditions that may exclude someone from participating, such as having severe infections, recent cancer history, or being pregnant. The trial is not yet recruiting participants, so it’s important to stay tuned for updates if you or someone you know might be interested in joining. Participants can expect to be monitored closely throughout the study to ensure their safety and to gather valuable information about how well the treatment works.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years at the time of signing the informed consent form, regardless of gender.
• • 2. BMI (Body Mass Index) ≥ 18 kg/m² at the time of screening.
• • 3. Presence of objective signs of inflammation at the time of screening.
• • 4. The subject voluntarily signs the ICF (informed consent form) before the start of any study-related procedures.
• • 5. 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.
• Exclusion Criteria:
• • 1. Subjects with active systemic infection or severe infection.
• • 2. Subjects with active tuberculosis or latent tuberculosis infection.
• • 3. Subjects with lymphoma or lymphoproliferative disease.
• • 4. Subjects with uncontrolled hypertension.
• • 5. Subjects with history of malignancy within the past 5 years or current malignancy.
• • 6. Subjects with moderate to severe congestive heart failure.
• • 7. Subjects with history of organ transplantation, or severe, progressive, or uncontrolled diseases of any organ system.
• • 8. Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG at the time of screening.
• • 9. Pregnant or breastfeeding women.
• • 10. known allergy to the study drug or any of its components.
• • 11. Subjects with history of alcohol abuse or illegal drug use within the past year.
• • 12. Receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period.
• • 13. Blood donation of approximately 500 mL within 8 weeks before randomization, or plans to donate blood during the study period.