The Phase 4 clinical trial NCT05070455 was initiated in September of 2022 with to evaluate the pharmacokinetics, efficacy, and safety of immune globulin intravenous, human-slra (Asceniv) in pediatric patients with primary immunodeficiency diseases (PIDD). The resulting FDA-approved label expansion broadened Asceniv’s pediatric indication from adolescents 12 to 17 years of age to include pediatric patients 2 years of age and older. Asceniv first received FDA approval in 2019 for the treatment of primary humoral immunodeficiency in adults and adolescents (12 to 17 years of age).

Today’s spotlight trial, NCT05070455, saw 12 participants enrolled from three different locations in the United States: Colorado, South Carolina, and Utah. Participation eligibility included being between 2 and 11 years old, and meeting the trial's six inclusion criteria, which included a confirmed and documented clinical diagnosis of primary immunodeficiency disease including but not limited to: common variable immunodeficiency, X-linked and autosomal forms of agammaglobulinemia, hyper-IgM syndrome, or antibody deficiencies. Selected participants were giving an intravenous infusion of Asceniv on study day one and every 21 or 28 days thereafter according to their current level of IGIV treatment. NCT05070455 completed in June of 2023.

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)
  • Sponsor: ADMA Biologics
  • Description: This is a Phase IV, multicenter, open-label study of Asceniv administered as an intravenous infusion of Asceniv (IGIV) 300-800 mg/kg every 21 or 28 days in approximately 12 pediatric subjects with primary immunodeficiency diseases (PIDD). The study will be conducted at 5-7 centers in the United States, with subjects receiving six (28 day cycle) or seven (21 day cycle) doses of Asceniv during the study.
  • Intervention(s): Asceniv
  • Primary Outcome Measures; Time Frames: Cmax; At prior to, end of infusion, and 60 minutes, two hours, 24 hours, 48 hours, four days, seven days, 14 days, and either 21 or 28 days dependent upon infusion schedule. Tmax; At prior to, end of infusion, and 60 minutes, two hours, 24 hours, 48 hours, four days, seven days, 14 days, and either 21 or 28 days dependent upon infusion schedule. AUC(0-ʈ); At prior to, end of infusion, and 60 minutes, two hours, 24 hours, 48 hours, four days, seven days, 14 days, and either 21 or 28 days dependent upon infusion schedule. AUC (0-∞); At prior to, end of infusion, and 60 minutes, two hours, 24 hours, 48 hours, four days, seven days, 14 days, and either 21 or 28 days dependent upon infusion schedule. Terminal phase elimination half-life (ʈ½); At prior to, end of infusion, and 60 minutes, two hours, 24 hours, 48 hours, four days, seven days, 14 days, and either 21 or 28 days dependent upon infusion schedule. Terminal phase elimination rate (λZ); At prior to, end of infusion, and 60 minutes, two hours, 24 hours, 48 hours, four days, seven days, 14 days, and either 21 or 28 days dependent upon infusion schedule.
  • Primary Completion: March 2023
  • Study Details
  • Source

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