A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) 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 (TCR) CFTR Mutation and No F508del Mutation

  • End date
    Feb 28, 2024
  • participants needed
  • sponsor
    Vertex Pharmaceuticals Incorporated
Updated on 28 July 2022
forced expiratory volume
cftr gene


The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants 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 TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

Condition Cystic Fibrosis
Treatment IVA, ELX/TEZ/IVA, VX-121/TEZ/D-IVA, Placebo (matched to VX-121/TEZ/D-IVA), Placebo (matched to ELX/TEZ/IVA), Placebo (matched to IVA)
Clinical Study IdentifierNCT05076149
SponsorVertex Pharmaceuticals Incorporated
Last Modified on28 July 2022


Yes No Not Sure

Inclusion Criteria

Participant has one of the following genotypes
Homozygous for F508del
Heterozygous for F508del and a gating (F/G) mutation
Heterozygous for F508del and a residual function (F/RF) mutation
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 (FEV1) value >=40% and <=90% of predicted mean
for age, sex, and height for participants currently receiving CFTR protein
modulator therapy; FEV1 >=40% and <=80% for participants not currently
receiving CFTR protein modulator therapy

Exclusion Criteria

History of solid organ or hematological transplantation
Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
Lung infection with organisms associated with a more rapid decline in pulmonary status
Pregnant or breast-feeding females
Other protocol defined Inclusion/Exclusion criteria may apply
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