NCT03224351

A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-659	Tablet for oral administration.
DRUG	TEZ/IVA	TEZ/IVA fixed-dose combination tablet for oral administration.
DRUG	IVA	Tablet for oral administration.
DRUG	Placebo (matched to VX-659/TEZ/IVA)	Placebo matched to VX-659 and TEZ/IVA.
DRUG	TEZ	Tablet for oral administration.
DRUG	VX-561	Tablet for oral administration.
DRUG	Placebo (matched to VX-659/TEZ/VX-561)	Placebo matched to VX-659, TEZ and VX-561.

Timeline

• Start date: 2017-08-08
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2017-07-21
• Last updated: 2021-04-22
• Results posted: 2021-04-22

Locations

47 sites across 4 countries: United States, Ireland, Israel, United Kingdom

Regulatory

• FDA-regulated drug study