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A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

NCT05076149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2024-06-13

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.

Conditions

Interventions

DRUG

VX-121/TEZ/D-IVA

Fixed-dose combination tablets for oral administration.

DRUG

ELX/TEZ/IVA

Fixed-dose combination tablets for oral administration.

DRUG

IVA

Tablet for oral administration.

DRUG

Placebo (matched to VX-121/TEZ/D-IVA)

Placebo matched to VX-121/TEZ/D-IVA for oral administration.

DRUG

Placebo (matched to ELX/TEZ/IVA)

Placebo matched to ELX/TEZ/IVA for oral administration.

DRUG

Placebo (matched to IVA)

Placebo matched to IVA for oral administration.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2023-05-18
Completion
2023-11-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Sweden
  • Switzerland
  • 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 NCT05076149 on ClinicalTrials.gov