A Phase 3, Open-label Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 to Less Than 24 Months of Age

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503230-49-00

Acronym

VX22-445-122

Enrollment

Registered

2024-01-24

Start date

2024-07-16

Completion date

2025-09-01

Last updated

2025-08-19

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 assessments as determined by AEs, clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry

Detailed description

PK parameters of ELX, TEZ, IVA, and relevant metabolites, Absolute change in sweat chloride (SwCl) from baseline through Week 24

Interventions

DRUGVX-770 granules

DRUGVX-445/VX-661/VX-770 fixed-dose combination granules

DRUGVX-445/VX-661/VX-770 granules

DRUGKalydeco 25 mg granules in sachet

DRUGKalydeco 50 mg granules in sachet

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Safety and tolerability assessments as determined by AEs, clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry	—

Secondary

Measure	Time frame
PK parameters of ELX, TEZ, IVA, and relevant metabolites, Absolute change in sweat chloride (SwCl) from baseline through Week 24	—

Countries

Denmark, Germany, Netherlands

Outcome results

None listed

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