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

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

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

Study Overview

• Status: Recruiting
• Conditions: Active Non-radiographic Axial Spondyloarthritis
• Intervention / Treatment: Drug: SHR-1314 Injection; Drug: SHR-1314 Placebo Injection

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lihua Lin; Phone Number: +86-0518-82342973; Email: lihua.lin.ll12@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Jian Zhu; Phone Number: +86-010- 55499314; Email: Jian_jzhu@126.com
      • Principal Investigator: Jian Zhu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1314 Injection; Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period.	Drug: SHR-1314 Injection; SHR-1314 injection.
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.	Drug: SHR-1314 Injection; SHR-1314 injection.; Drug: SHR-1314 Placebo Injection; SHR-1314 placebo injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).	At the 16th week after administration.

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score).	At the 16th week after administration.
Change in CRP (C-reactive protein) value from baseline.	At the 16th week after administration.
AEs (adverse events).	Up to 60 weeks after administration.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Spondylitis; Spondylarthritis
• Other Study ID Numbers: SHR-1314-306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No