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A two-period, crossover, Phase 1, bioequivalence study comparing subcutaneous and intramuscular routes of administration of peginterferon beta-1a: macrophage-producing neopterin levels as biomarker

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Trial Profile

A two-period, crossover, Phase 1, bioequivalence study comparing subcutaneous and intramuscular routes of administration of peginterferon beta-1a: macrophage-producing neopterin levels as biomarker

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Dec 2021

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At a glance

Most Recent Events

  • 15 Oct 2021 Results comparing PK profiles and safety outcomes of SC and IM peginterferon beta-1a in Black/African American and white participants, presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis
  • 01 Feb 2021 According to a Biogen media release, based on the data from this study, the U.S. Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS).
  • 21 Dec 2020 According to a Biogen media release, European Commission (EC) has approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of relapsing-remitting multiple sclerosis (MS) based on this study.

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