RecruitingPhase 3

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

China380 participantsStarted 2025-04-29

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 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, 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.

What they're measuring

Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).

Timeframe: At the 16th week after administration.

Trial details

NCT IDNCT06860750

SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-02

Contact for this trial

Lihua Lin

+86-0518-82342973 lihua.lin.ll12@hengrui.com

View on ClinicalTrials.gov More Active Non-radiographic Axial Spondyloarthritis trials