A Phase 3, Open-label Study Evaluating the Long‑term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503081-74-00

Acronym

VX22-121-106

Enrollment

Registered

2023-06-16

Start date

2023-09-05

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

Safety and tolerability of long-term treatment with VNZ/TEZ/D-IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry

Detailed description

Absolute change in SwCl, Absolute change in ppFEV1, Number of PEx and CF-related hospitalizations, Absolute change in CFQ-R RD score, Absolute change in BMI and BMI-for-age z score, Absolute change in weight and weight-for-age z score, Absolute change in height and height-for-age z score

Interventions

DRUGVX-121/VX-661/VX-561 Film-coated tablet

DRUGVX-121/VX-661/VX-561 granules

DRUGAlyftrek 125 mg/50 mg/10 mg film-coated tablets

DRUGAlyftrek 50 mg/20 mg/4 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of long-term treatment with VNZ/TEZ/D-IVA based on adverse events (AEs), clinical laboratory values, ECGs, vital signs, and pulse oximetry	—

Secondary

Measure	Time frame
Absolute change in SwCl, Absolute change in ppFEV1, Number of PEx and CF-related hospitalizations, Absolute change in CFQ-R RD score, Absolute change in BMI and BMI-for-age z score, Absolute change in weight and weight-for-age z score, Absolute change in height and height-for-age z score	—

Countries

France, Germany, Netherlands, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026