A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)
NCT ID: NCT06222671
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2024-03-22
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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608 Dose A
608 Dose A subcutaneous (SC) injection.
608
608 subcutaneous (SC) injection.
608 Dose B
608 Dose B subcutaneous (SC) injection.
608
608 subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Interventions
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608
608 subcutaneous (SC) injection.
608
608 subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Qinghong Zhou, BS
Role: STUDY_DIRECTOR
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Xiaofeng Zeng, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Site 01
Beijing, Beijing Municipality, China
Site 03
Beijing, Beijing Municipality, China
Site 05
Chongqing, Chongqing Municipality, China
Site 02
Zhengzhou, Henan, China
Site 04
Nanjing, Jiangsu, China
Site 06
Shenzhen, Shenzhen, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSGJ-608-nr-axSpA-II-01
Identifier Type: -
Identifier Source: org_study_id
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