Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05033080 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
NCT05033080: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT05033080 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 435 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05033080, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 435 participants
- Enrollment target
Study Summary
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
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 | 435 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 3 |
What the finished NCT05033080 record still lists
NCT05033080 is an interventional study that assigns participants to a tested intervention. The registered 435 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 (44% lower).
The record links to 0 conditions, and to 5 interventions - of which VX-121/TEZ/D-IVA is the first listed.
NCT05033080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05033080 about?
NCT05033080 is a clinical study titled "A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)". The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
What is the current status of trial NCT05033080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2021-09-14. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT05033080?
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 NCT05033080?
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 NCT05033080's enrollment target sits among peer trials
435 875th of 2000 higher than 1,125 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05563220 · 435 participants · Phase 1
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
- NCT07088926 · 435 participants · Phase 2
A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization
- NCT02622542 · 436 participants · NA
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
- NCT05918211 · 436 participants · Phase 3
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI