VX20-121-103: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation

About this Study

The purpose of this study is to learn more about the safety and effects of taking VX-121/TEZ/D-IVA in patients with cystic fibrosis.

Sponsor Protocol ID:VX20-121-103
IRB Number:2021-1102
Actively Enrolling
Phase 3
August 15, 2022
Eligibility Criteria
12 years old
Both Male and Female

Inclusion Criteria
  • Must have one of the follow genotypes:                                   Homozygous for F508del; Heterozygous for F508del and a gating (F/G) mutation; Heterozygous for F508del and a residual function (F/RF) mutation; or at least 1 other TCR CFTR gene mutation identified as responsive to ELX/TEZ/IVA and no F508del mutation
  • Forced expiratory volume in 1 second

Exclusion Criteria
  • History of solid organ or hematological transplantation
  • Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment
  • Lung infection with organisms associated with a more rapid decline in pulmonary status
  • Pregnant or breast-feeding females

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Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Stephanie Moore
Phone Number: 601-496-7812
Email: smoore13@umc.edu
Principal Investigator:Spurzem, John R
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