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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 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 597 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05076149
The ClinicalTrials.gov registry entry for NCT05076149 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which VX-121/TEZ/D-IVA is the first listed.
NCT05076149 reports 0 study locations.
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.
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