RecruitingPhase 3NCT06860750
A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment
380 participants
Start Date
Apr 29, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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.
Exclusion Criteria13
- 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.
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Interventions
DRUGSHR-1314 Injection
SHR-1314 injection.
DRUGSHR-1314 Placebo Injection
SHR-1314 placebo injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06860750