RecruitingPhase 2NCT06222671
A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Non-radiographic Axial Spondyloarthritis (Nr-axSpA)
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Enrollment
180 participants
Start Date
Mar 22, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
DRUG608
608 subcutaneous (SC) injection.
DRUG608
608 subcutaneous (SC) injection.
DRUGPlacebo
Placebo subcutaneous (SC) injection.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06222671
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