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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

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

Egyéb

• Pregnant or breastfeeding women.

• 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.