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A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age

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Trial Profile

A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2025

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At a glance

  • Drugs Deutivacaftor/tezacaftor/vanzacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Acronyms RIDGELINE; RIDGELINE 105
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 04 Feb 2025 Planned primary completion date changed from 1 Jun 2030 to 30 Jun 2030.
  • 03 Feb 2025 Planned End Date changed from 1 Jun 2030 to 30 Jun 2030.
  • 20 Dec 2024 According to a Vertex Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), for the treatment of cystic fibrosis (CF) in people 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to ALYFTREK.

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