Phase
Condition
Ankylosing Spondylitis
Treatment
SHR-1314 Injection
SHR-1314 Placebo Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years at the time of signing the informed consent form, regardless ofgender.
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 ofany study-related procedures.
The subject is able to communicate effectively with the investigator, understandsand is willing to strictly adhere to the requirements of the clinical study protocolto complete the study.
Exclusion
Exclusion Criteria:
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, oruncontrolled diseases of any organ system.
Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG atthe 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 receivea live vaccine during the study period.
Blood donation of approximately 500 mL within 8 weeks before randomization, or plansto donate blood during the study period.
Study Design
Connect with a study center
Chinese PLA General Hospital
Beijing, Beijing 100039
ChinaActive - Recruiting
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