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

NCT03224351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-04-22

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-08
Primary Completion
2018-02-28
Completion
2018-02-28
FDA Drug
Yes

Countries

  • United States
  • Ireland
  • Israel
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03224351 on ClinicalTrials.gov