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

RecruitingPhase 3Ages 18 Years - anyAllSuzhou Suncadia Biopharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 18 years at the time of signing the informed consent form, regardless of gender. 2. BMI (Body Mass Index) โ‰ฅ 18 kg/mยฒ 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.
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What it tests

  • SHR-1314 Injection
  • SHR-1314 Placebo Injection
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Where

1 site
Chinese PLA General Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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