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

NCT02951195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-01-28

Study results available
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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

Interventions

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).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02951195 on ClinicalTrials.gov