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A Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency

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Trial Profile

A Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 31 Jul 2024

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Pharmacokinetics; Registrational
  • Sponsors Grifols

    • Most Recent Events

    • 29 Jul 2024 According to a Grifols media release, the United States Food and Drug Administration (FDA) has approved an expanded label for XEMBIFY, the companys 20% subcutaneous immunoglobulin (SCIg), to include treatment-naive patients with primary humoral immunodeficiencies (PI), FDA approval of the Supplemental Biologics Application (sBLA) also includes biweekly dosing and is supported by phase 4 clinical trial (NCT04566692) data shared last year.
    • 20 Jul 2023 Primary endpoint has been met. (Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval (AUC0-, biweekly or AUC0-14 days)), according to a Grifols media release.
    • 20 Jul 2023 Results presented in a Grifols media release.

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