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Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

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Trial Profile

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Dec 2021

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At a glance

  • Drugs AR 101 (Primary)
  • Indications Peanut hypersensitivity
  • Focus Adverse reactions; Registrational
  • Sponsors Aimmune Therapeutics

    • Most Recent Events

    • 31 Jan 2020 According to an Aimmune Therapeutics media release, in connection with the FDA approval announcement the company will host a conference call and webcast today.
    • 31 Jan 2020 According to an Aimmune Therapeutics media release, the the U.S. Food and Drug Administration (FDA) approved PALFORZIA(AR-101) for treatment of peanut allergy in children and adolescents aged 4 - 17 years. The Biologics License Application (BLA) included efficacy and safety data from seven clinical studies, including the pivotal Phase 3 PALISADE and RAMSES clinical trials. In addition, data from ARC001, ARC002, ARC004, ARC008 and ARC011 were included.
    • 25 Jun 2018 Status changed from active, no longer recruiting to completed.

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