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This is an open-label Phase III clinical study to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis.
Full description
This is an open-label, single-arm, multi-center phase III study. The purpose of this study is to evaluate the long-term safety and efficacy of AK101 injection in subjects with moderate-to-severe plaque psoriasis. Subjects who have completed the previous Akeso registration trial with AK101 injection (AK101-302) and subjects who are to be newly enrolled will both receive AK101 135mg injection subcutaneously.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
Applicable for subjects newly enrolled:
Key Exclusion Criteria:
Applicable for subjects who have completed the previous Akeso trial (AK101-302) with AK101 injection:
Applicable for subjects newly enrolled:
Primary purpose
Allocation
Interventional model
Masking
950 participants in 1 patient group
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Central trial contact
Guoqin Wang, Doctor
Data sourced from clinicaltrials.gov
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