A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Official Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

This study is designed to evaluate the efficacy and safety of VX-661 in combination with ivacaftor. The active treatment regimen will be comprised of a morning dose of a fixed-dose combination tablet of 100 mg VX-661/150 mg ivacaftor once daily (qd) and an evening dose of ivacaftor 150 mg to be taken approximately 12 hours after the morning dose. The placebo regimen will be visually matched tablets to be taken with the same schedule as the active treatment.

ClinicalTrials.gov ID: NCT02347657

Principal Investigator: McColley, Susanna, MD

Study Type: Interventional

Currently Recruiting Patients: No

Contact Information:

Naiomi Nemoto

Clinical Research Coordinator

312.227.6266