A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
NCT ID: NCT06860750
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
380 participants
INTERVENTIONAL
2025-04-29
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR-1314 Injection
Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period.
SHR-1314 Injection
SHR-1314 injection.
SHR-1314 Placebo Injection
Subjects will receive SHR-1314 placebo injection in the core treatment period and receive SHR-1314 injection in the extended treatment period.
SHR-1314 Injection
SHR-1314 injection.
SHR-1314 Placebo Injection
SHR-1314 placebo injection.
Interventions
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SHR-1314 Injection
SHR-1314 injection.
SHR-1314 Placebo Injection
SHR-1314 placebo injection.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-1314-306
Identifier Type: -
Identifier Source: org_study_id
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