Clinical trial NCT06860750: A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Active Non-radiographic Axial Spondyloarthritis
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Proportion of participants achieving ASAS 40 (ankylosing spondylitis disease activity score).
timeFrame: At the 16th week after administration.
Secondary outcomes:
measure: Proportion of participants achieving ASAS 20 (ankylosing spondylitis disease activity score).
timeFrame: At the 16th week after administration.
measure: Change in CRP (C-reactive protein) value from baseline.
timeFrame: At the 16th week after administration.
measure: AEs (adverse events).
timeFrame: Up to 60 weeks after administration.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: