A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Study ID: STU 022018-086
Summary
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).
Primary objective To evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TeZ) and VX-561 (deuterated ivacaftor, also known as CTP-656) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation Secondary objectives * To evaluate the long-term efficacy of VX-445 in TC with TeZ and VX-561 * To evaluate the pharmacodynamics (PD) of VX-445 in TC with TeZ and VX-561