A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX,
 VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
 cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function
 mutation (F/G and F/RF genotypes).
Key Inclusion Criteria:

 -  Subject has a confirmed diagnosis of CF and is heterozygous for F508del and either a
 gating or residual function mutation (F/G and F/RF genotypes)

 -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
 age, sex, and height

 Key Exclusion Criteria:

 -  Clinically significant cirrhosis with or without portal hypertension

 -  Lung infection with organisms associated with a more rapid decline in pulmonary status

 -  Solid organ or hematological transplantation

 Other protocol defined Inclusion/Exclusion criteria may apply