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NCT05076149 · ClinicalTrials.gov registry record · Phase 3
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 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 597
- Enrollment target
NCT05076149: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT05076149 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 597 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05076149, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 597 participants
- Enrollment target
Study 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.
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Interventions
- DRUG VX-121/TEZ/D-IVA
- DRUG IVA
- DRUG ELX/TEZ/IVA
- DRUG Placebo (matched to VX-121/TEZ/D-IVA)
- DRUG Placebo (matched to ELX/TEZ/IVA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 3 |
What the finished NCT05076149 record still lists
NCT05076149 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 5 interventions - of which VX-121/TEZ/D-IVA is the first listed.
NCT05076149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05076149 about?
NCT05076149 is a clinical study titled "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". 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 co...
What is the current status of trial NCT05076149?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 597 participants. The study started on 2021-10-27. Estimated completion is 2023-11-30.
What interventions are being tested in trial NCT05076149?
The interventions under investigation include: VX-121/TEZ/D-IVA (DRUG), IVA (DRUG), ELX/TEZ/IVA (DRUG), Placebo (matched to VX-121/TEZ/D-IVA) (DRUG), Placebo (matched to ELX/TEZ/IVA) (DRUG).
Who is sponsoring clinical trial NCT05076149?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05076149's enrollment target sits among peer trials
597 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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