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New treatment option for Active Non-radiographic Axial Spondyloarthritis
Official title A Trial of SHR-1314 Injection in Adult Patients With Active Non-radiographic Axial Spondyloarthritis
ClinicalTrials.gov ID: NCT06860750
What this study is testing
What is SHR-1314 Injection?
SHR-1314 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for active non-radiographic axial spondyloarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is being conducted to evaluate the efficacy and safety of SHR-1314 injection in adult patients with active non-radiographic axial spondyloarthritis.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- people with active systemic infection or severe infection.
- people with active tuberculosis or latent tuberculosis infection.
- people with lymphoma or lymphoproliferative disease.
- people with uncontrolled hypertension.
- people with history of malignancy within the past 5 years or current malignancy.
- people with moderate to severe congestive heart failure.
See the full eligibility criteria
- 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.
- people with active systemic infection or severe infection.
- people with active tuberculosis or latent tuberculosis infection.
- people with lymphoma or lymphoproliferative disease.
- people with uncontrolled hypertension.
- people with history of malignancy within the past 5 years or current malignancy.
- people with moderate to severe congestive heart failure.
- people 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.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.