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

NCT06860750 | Recruiting Phase 3

• 1 other identifier: SHR-1314-306
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Active Non-radiographic Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

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

  At the 16th week after administration.

Secondary Outcomes (3)

• 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.

Study Arms (2)

SHR-1314 Injection

EXPERIMENTAL

Subjects will receive SHR-1314 injection in the core treatment period and the extended treatment period.

Drug: SHR-1314 Injection

SHR-1314 Placebo Injection

PLACEBO COMPARATOR

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; Drug: SHR-1314 Placebo Injection

Interventions

SHR-1314 Injection DRUG

SHR-1314 injection.

SHR-1314 Injection; SHR-1314 Placebo Injection

SHR-1314 Placebo Injection DRUG

SHR-1314 placebo injection.

SHR-1314 Placebo Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnant or breastfeeding women.
• known allergy to the study drug or any of its components.
• Subjects with history of alcohol abuse or illegal drug use within the past year.
• Receipt of a live vaccine within 12 weeks before randomization, or plans to receive a live vaccine during the study period.
• Blood donation of approximately 500 mL within 8 weeks before randomization, or plans to donate blood during the study period.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Central Study Contacts

Lihua Lin

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CN (1)