A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)

Launched by SUNSHINE GUOJIAN PHARMACEUTICAL (SHANGHAI) CO., LTD. · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 608 for patients with a condition known as non-radiographic axial spondyloarthritis (nr-axSpA), which is a type of inflammatory arthritis that primarily affects the spine and pelvis. The main goal of the study is to find out how effective and safe this new treatment is for people who have this condition. The trial is currently looking for participants aged 18 and older and is open to both men and women who have been diagnosed with nr-axSpA and experience significant back pain.

To be eligible for the trial, participants need to have signs of inflammation that can be seen on an MRI or through blood tests, as well as a baseline pain score of 4 or higher on a scale of 0 to 10. However, individuals with certain health issues, like active infections or a history of cancer, cannot participate. If you decide to take part in this study, you will receive the treatment and be monitored closely for any side effects and how well it works. This trial is an important step in finding new options for those living with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Female and male patients at least 18 years of age at the time of screening.
• • 2. Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
• • 3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
• • 4. Total back pain as measured by NRS ≥ 4 at baseline
• Exclusion Criteria:
• • 1. Patients with other uncontrolled active inflammatory diseases.
• • 2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
• • 3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• • 4. History of cancer.
• • 5. Known or suspected history of immunosuppression.
• • 6. Known with allergic or intolerant to mometasone furoate spray or 608/placebo.