Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03224351 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
A Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT03224351: Completed Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT03224351 is a Phase 2 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 124 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03224351, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Conditions Studied
Interventions
- DRUG IVA
- DRUG VX-659
- DRUG TEZ/IVA
- DRUG Placebo (matched to VX-659/TEZ/IVA)
- DRUG TEZ
Study Locations (20)
New York
- Albany Medical College - Albany
- Northwell Health, Long Island Jewish Medical Center - New Hyde Park
- Columbia University Medical Center - New York
- SUNY Upstate Medical University - Syracuse
Massachusetts
- Boston Children's Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Michigan
- University of Michigan Health System - Ann Arbor
- Helen DeVos Children's Hospital CF Center - Grand Rapids
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- University of Miami/Miller School of Medicine - Miami
Illinois
- Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants - Morton Grove
Indiana
- Indiana University Health - Indianapolis
Iowa
- The University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2018-02-28 |
| Phase | Phase 2 |
What the finished NCT03224351 record still lists
NCT03224351 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 5 interventions - of which IVA is the first listed.
NCT03224351 names 20 study sites across 15 states, led by New York, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT03224351 about?
NCT03224351 is a clinical study titled "A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis". This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous f...
What is the current status of trial NCT03224351?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2017-08-08. Estimated completion is 2018-02-28.
What conditions does trial NCT03224351 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03224351?
The interventions under investigation include: IVA (DRUG), VX-659 (DRUG), TEZ/IVA (DRUG), Placebo (matched to VX-659/TEZ/IVA) (DRUG), TEZ (DRUG).
Who is sponsoring clinical trial NCT03224351?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03224351 being conducted?
This trial has 20 study locations across Connecticut, Florida, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03224351's enrollment target sits among peer trials
124 52nd of 169 higher than 118 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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
-
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
RECRUITING · Phase 2
-
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
RECRUITING · Phase 2
-
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients with Cystic Fibrosis
RECRUITING · Phase 2
-
GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance
RECRUITING · Phase 2
-
A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF
RECRUITING · Phase 2
-
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
ACTIVE NOT RECRUITING · Phase 2
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
- NCT02523014 · 124 participants · Phase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
- NCT02670707 · 124 participants · Phase 3
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
- NCT02830724 · 124 participants · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
- NCT04748809 · 124 participants · NA
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
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