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ACTIVE_NOT_RECRUITINGPHASE3

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis

NCT05444257•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
•Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A

Exclusion Criteria

•History of drug intolerance in a parent study
•Pregnant or breast-feeding females at the time of enrollment in Part A

Locations (195)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner University of Arizona Medical Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Miller Children's Hospital / Long Beach Memorial

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Kaiser Permanente

Oakland, California, United States

University of California Davis Medical Center

Sacramento, California, United States

University of California San Francisco, Lung Transplant Program

San Francisco, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

National Jewish Health

Denver, Colorado, United States

Key Dates

Start Date

November 8, 2022

Primary Completion Date

October 30, 2026

Completion Date

October 30, 2026

Last Updated

September 5, 2025

Enrollment

822

ACTUAL participants

Conditions

Cystic Fibrosis

Interventions

VX-121/TEZ/D-IVA

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

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