Trials / Completed
CompletedNCT05076149
A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 597 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are homozygous for F508del, heterozygous for F508del and a gating (F/G) or residual function (F/RF) mutation, or have at least 1 other TCR CF transmembrane conductance regulator (CFTR) gene mutation and no F508del mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-121/TEZ/D-IVA | Fixed-dose combination tablets for oral administration. |
| DRUG | ELX/TEZ/IVA | Fixed-dose combination tablets for oral administration. |
| DRUG | IVA | Tablet for oral administration. |
| DRUG | Placebo (matched to VX-121/TEZ/D-IVA) | Placebo matched to VX-121/TEZ/D-IVA for oral administration. |
| DRUG | Placebo (matched to ELX/TEZ/IVA) | Placebo matched to ELX/TEZ/IVA for oral administration. |
| DRUG | Placebo (matched to IVA) | Placebo matched to IVA for oral administration. |
Timeline
- Start date
- 2021-10-27
- Primary completion
- 2023-05-18
- Completion
- 2023-11-30
- First posted
- 2021-10-13
- Last updated
- 2024-06-13
- Results posted
- 2024-06-13
Locations
170 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05076149. Inclusion in this directory is not an endorsement.