A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)
NCT ID: NCT06242652
Last Updated: 2024-10-23
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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ACTIVE_NOT_RECRUITING
PHASE2
250 participants
INTERVENTIONAL
2024-03-19
2025-06-15
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 Dose A
608 subcutaneous (SC) injection.
608 Dose B
608 Dose B subcutaneous (SC) injection.
608 Dose B
608 subcutaneous (SC) injection.
608 Dose C
608 Dose C subcutaneous (SC) injection.
608 Dose C
608 subcutaneous (SC) injection.
Positive control group
Adalimumab subcutaneous (SC) injection.
Adalimumab
Adalimumab subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Interventions
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608 Dose A
608 subcutaneous (SC) injection.
608 Dose B
608 subcutaneous (SC) injection.
608 Dose C
608 subcutaneous (SC) injection.
Adalimumab
Adalimumab subcutaneous (SC) injection.
Placebo
Placebo subcutaneous (SC) injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>= 4 and a Patient's Assessment of Total Back Pain score \>= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
4. If entering the study on concomitant NSAIDs for AS, participant must be on stable dose(s) for at least 2 weeks prior to the Baseline visit.
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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Other Identifiers
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SSGJ-608-AS-II-01
Identifier Type: -
Identifier Source: org_study_id
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