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

Last updated: May 7, 2025
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Ankylosing Spondylitis

Treatment

SHR-1314 Injection

SHR-1314 Placebo Injection

Clinical Study ID

NCT06860750
SHR-1314-306
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years at the time of signing the informed consent form, regardless ofgender.

  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 ofany study-related procedures.

  5. 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:

  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, oruncontrolled diseases of any organ system.

  8. Presence of protocol-defined abnormalities in laboratory tests and/or 12-lead ECG atthe 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 receivea live vaccine during the study period.

  13. Blood donation of approximately 500 mL within 8 weeks before randomization, or plansto donate blood during the study period.

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: SHR-1314 Injection
Phase: 3
Study Start date:
April 29, 2025
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100039
    China

    Active - Recruiting

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