28.05.2024 03:13:50
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Innovent:Phase 3 Trial Of Picankibart In Severe Plaque Psoriasis Meets Primary & Key Secondary Goals
(RTTNews) - Innovent Biologics Inc. announced that picankibart, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody injection, has met all the primary endpoints and key secondary endpoints in the Phase 3 registrational study (CLEAR-1) in Chinese subjects with moderate to severe plaque psoriasis.
CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients.
Innovent plans to submit a new drug application (NDA) for picankibart in the treatment of psoriasis to the Center for Drug Evaluation (CDE) of National Medical Product Administration (NMPA).
The overall safety profile of picankibart was favorable during the study, and no new safety signals were identified compared with previous clinical studies. Follow-up of the current study is ongoing and complete data will be published at future academic conferences or in peer-reviewed academic journals.
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