A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

  • End date
    Jan 11, 2024
  • participants needed
  • sponsor
    Vertex Pharmaceuticals Incorporated
Updated on 11 August 2022
forced expiratory volume


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 heterozygous for F508del and a minimal function mutation (F/MF participants).

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 IdentifierNCT05033080
SponsorVertex Pharmaceuticals Incorporated
Last Modified on11 August 2022


Yes No Not Sure

Inclusion Criteria

Heterozygous for F508del and a minimal function mutation (F/MF genotype)
Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted mean for age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy; FEV1 >=40% and <=80% for participants not currently receiving ELX/TEZ/IVA

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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