NCT03447249

A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-659/TEZ/IVA	Participants received VX-659/TEZ/IVA orally once daily in the morning.
DRUG	IVA	Participants received IVA orally once daily in the evening.
DRUG	Placebo	Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.

Timeline

• Start date: 2018-03-07
• Primary completion: 2019-02-05
• Completion: 2019-02-05
• First posted: 2018-02-27
• Last updated: 2020-03-13
• Results posted: 2020-03-13

Locations

101 sites across 11 countries: United States, Australia, Canada, Denmark, Germany, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study