A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
NCT05444257 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 822
Last updated 2026-05-05
Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Conditions
Interventions
- DRUG
-
VX-121/TEZ/D-IVA
Fixed-dose combination tablets for oral administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-08
- Primary Completion
- 2026-10-30
- Completion
- 2026-10-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Canada
- Czechia
- Denmark
- France
- Germany
- Greece
- Hungary
- Ireland
- Israel
- Italy
- Netherlands
- New Zealand
- Norway
- Poland
- Portugal
- Spain
- Sweden
- Switzerland
- United Kingdom
Study Locations
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