Overview
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
Description
The purpose of this study is to demonstrate the clinical efficacy, safety and tolerability of 608 compared to placebo in patients with nr-axSpA.
Eligibility
Inclusion Criteria:
- Female and male patients at least 18 years of age at the time of screening.
- Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
- Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
- Total back pain as measured by NRS ≥ 4 at baseline
Exclusion Criteria:
- Patients with other uncontrolled active inflammatory diseases.
- Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
- Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
- History of cancer.
- Known or suspected history of immunosuppression.
- Known with allergic or intolerant to mometasone furoate spray or 608/placebo.