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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Lihua Lin
lihua.lin.ll12@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2028-12
Participants
Target number of participants: 380
Treatments
Experimental: SHR-1314 Injection
Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.