A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)
NCT ID: NCT07261644
Last Updated: 2025-12-10
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
PHASE3
500 participants
INTERVENTIONAL
2025-11-07
2027-11-18
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
608 subcutaneous (SC) injection.
608 dose
608 subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Interventions
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608 dose
608 subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years of age at the time of signing the ICF, with no gender restrictions;
3. Meet the 1984 modified New York criteria for ankylosing spondylitis (AS);
4. Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment;
5. Willing to practice contraception and have no plans for pregnancy, sperm donation, or egg donation from the screening period until at least 6 months after the last dose.
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.
18 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Site 01
Beijing, Beijing Municipality, 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-AS-III-01
Identifier Type: -
Identifier Source: org_study_id
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