NCT02951195

A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (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 active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-152	Tablet for oral administration.
DRUG	TEZ/IVA	Fixed-dose combination tablet for oral administration.
DRUG	IVA	Tablet for oral administration.
DRUG	Placebo	Placebo matched to VX-152.
DRUG	Placebo	Placebo matched to VX-152/TEZ/IVA triple combination (TC).

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-11-01
• Last updated: 2021-01-28
• Results posted: 2021-01-28

Locations

16 sites across 1 country: United States