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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514173-22-00

Acronym

VX20-121-104

Enrollment

331

Registered

2024-06-25

Start date

2023-02-28

Completion date

Unknown

Last updated

2025-10-09

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 VX-121/TEZ/D-IVA based on adverse events, clinical laboratory values, ECGs, vital signs, and pulse oximetry

Detailed description

Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1), Absolute change from baseline in sweat chloride (SwCl), Number of pulmonary exacerbations (PEx)

Interventions

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

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

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of long-term treatment with VX-121/TEZ/D-IVA based on adverse events, clinical laboratory values, ECGs, vital signs, and pulse oximetry	—

Secondary

Measure	Time frame
Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1), Absolute change from baseline in sweat chloride (SwCl), Number of pulmonary exacerbations (PEx)	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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