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A Randomized, Double-blinded, and Placebo-controlled Phase I/II Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

Trial Profile

A Randomized, Double-blinded, and Placebo-controlled Phase I/II Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 25 Aug 2023

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At a glance

  • Drugs Ebdarokimab (Primary)
  • Indications Plaque psoriasis
  • Focus Adverse reactions
  • Sponsors Akeso Biopharma
  • Most Recent Events

    • 24 Aug 2023 According to an Akeso Biopharma Media Release, the New Drug Application (NDA) for its fully human IgG1 monoclonal antibody, ebdarokimab (IL-12/lL-23, AK101) has been accepted by the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) for the treatment of adult patients with moderate-to-severe plaque-type psoriasis
    • 14 Nov 2022 Results(n=24) assessing safety, tolerability, pharmacokinetics (PK), efficacy and immunogenicity of Ebdarokimab in moderate to severe plaque psoriasis patients presented at the ACR Convergence 2022
    • 19 Nov 2019 Status changed from recruiting to completed.
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