A Phase 3 Open-label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515606-90-00

Acronym

VX20-445-112

Enrollment

Registered

2024-08-29

Start date

2022-04-01

Completion date

2026-01-14

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 of ELX/TEZ/IVA based on adverse events (AEs), clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry

Detailed description

Absolute change in sweat chloride (SwCl), Absolute change in lung clearance index (LCI)2.5

Interventions

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

DRUGKalydeco 75 mg granules in sachet

DRUGKalydeco 75 mg film-coated tablets

DRUGVX-770 75mg

DRUGVX-770 granules

DRUGKaftrio 37.5 mg/25 mg/50 mg film-coated tablets

DRUGKaftrio 75 mg/50 mg/100 mg film-coated tablets

DRUGKalydeco 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Secondary

Measure	Time frame
Absolute change in sweat chloride (SwCl), Absolute change in lung clearance index (LCI)2.5	—

Primary

Measure	Time frame
Safety and tolerability of ELX/TEZ/IVA based on adverse events (AEs), clinical laboratory values, standard 12-lead ECGs, vital signs, and pulse oximetry	—

Countries

Germany

Outcome results

None listed

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