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A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

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Trial Profile

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Elexacaftor/ivacaftor/tezacaftor (Primary) ; Ivacaftor (Primary) ; Ivacaftor/tezacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 28 Feb 2025 According to a Vertex Pharmaceuticals media release, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for the treatment of people with cystic fibrosis (CF) aged 2 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
  • 09 Nov 2023 144-Week Interim Results From a 192-Week Open-label Extension Study assess long-term safety and efficacy of ELX/TEZ/IVA in these patients published in the European Respiratory Journal
  • 18 Jun 2021 According to a Vertex Pharmaceuticals media release, Health Canada has granted Marketing Authorization for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common CF-causing mutation.This approval was supported by positive results of three global Phase 3 studies (Study 445-102, Study 445-103)

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