Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

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NCT05422222 · readout in 1,411 d

Sponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

210estimated

Sites

Countries

Australia, Canada, France +7

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2022-06-21

actual

When the study began enrolling

Primary completion

2030-06-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-06-30

estimated

The whole study's end, after follow-up

First posted

2022-06-16

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-28

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Cystic Fibrosis

Intervention

Drug: VX-121/TEZ/D-IVA — also filed as VX-121/VX-661/VX-561, VX-121/VX-661/CTP-656, VX-121/tezacaftor/deutivacaftor

Primary outcomes

what the primary-completion date above is the date OF

Part A: Observed Pre-dose Plasma Concentration (Ctrough) of VX-121, TEZ, D-IVA, and Relevant Metabolites

measured From Day 1 up to Day 22

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Day 1 up to Day 50

Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

measured From Day 1 up to Week 28

Publications

PMID 39756425 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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