An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO
NCT ID: NCT06299982
Last Updated: 2024-03-08
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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NOT_YET_RECRUITING
PHASE3
750 participants
INTERVENTIONAL
2024-05-15
2025-03-20
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
NONE
Study Groups
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608 160 mg W0+80 mg Q2W
Participants will receive starting dose of 160 milligrams (mg) 608 at week 0 followed by 80mg 608 once every two weeks (Q2W) by subcutaneous injection for 12 weeks.
608 Q2W
608 160 mg at week 0 + 80 mg Q2W (5 cycles)
608 160 mg Q4W
Participants will receive 160 milligrams 608 once every four weeks (Q4W) by subcutaneous injection for 12 weeks.
608 Q4W
608 160 mg Q4W (3 cycles)
Interventions
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608 Q2W
608 160 mg at week 0 + 80 mg Q2W (5 cycles)
608 Q4W
608 160 mg Q4W (3 cycles)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of plaque psoriasis according to the Chinese Guideline for the Diagnosis and Treatment of Psoriasis (2018).
Exclusion Criteria
* Other inflammatory diseases.
* Active autoimmune diseases.
* Pregnant or lactating women.
18 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SSGJ-608-PsO-III-02
Identifier Type: -
Identifier Source: org_study_id
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