Evaluating SHR-1314 Injection for 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

This study is testing if an injection called SHR-1314 can help adults with active non-radiographic axial spondyloarthritis feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06860750 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of SHR-1314 injection in adult patients diagnosed with active non-radiographic axial spondyloarthritis. Participants will receive either the SHR-1314 injection or a placebo to determine the treatment's effectiveness. The study will include adults aged 18 and older who show objective signs of inflammation. The trial is designed to provide insights into how well this new treatment can manage symptoms associated with this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with active non-radiographic axial spondyloarthritis and objective signs of inflammation.

Not a fit: Patients with active systemic infections, uncontrolled hypertension, or a history of malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of symptoms for patients with active non-radiographic axial spondyloarthritis.

How similar studies have performed: While this specific treatment approach is novel, similar studies targeting axial spondyloarthritis have shown promising results in the past.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lihua Lin

Conditions: Active Non-radiographic Axial Spondyloarthritis