ClinicalTrials.gov record
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
ClinicalTrials.gov ID: NCT05076149
Public ClinicalTrials.gov record NCT05076149. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT05076149
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Industry
- Enrollment
- 597 participants
Conditions and interventions
Conditions
Interventions
- VX-121/TEZ/D-IVA Drug
- ELX/TEZ/IVA Drug
- IVA Drug
- Placebo (matched to VX-121/TEZ/D-IVA) Drug
- Placebo (matched to ELX/TEZ/IVA) Drug
- Placebo (matched to IVA) Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 26, 2021
- Primary completion
- May 17, 2023
- Completion
- Nov 29, 2023
- Last update posted
- Jun 12, 2024
2021 – 2023
United States locations
- U.S. sites
- 62
- U.S. states
- 36
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Nemours Children's Specialty Care | Jacksonville | Florida | 32207 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | — |
| Nemours Children's Specialty Care, Pensacola | Pensacola | Florida | 32514 | — |
| Johns Hopkins All Children's Hospital Outpatient Care Center | St. Petersburg | Florida | 33701 | — |
| The Emory Clinic at Chantilly | Atlanta | Georgia | 30324 | — |
| St. Luke's Cystic Fibrosis Center of Idaho | Boise | Idaho | 83702 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Maine Medical Partners | Portland | Maine | 04102 | — |
| Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109-5212 | — |
| Harper University Hospital | Detroit | Michigan | 48201 | — |
| Spectrum Health Medical Group Adult Cystic Fibrosis Care Center | Grand Rapids | Michigan | 49546 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| CF Therapeutics Development Center of Western New York | Buffalo | New York | 14203 | — |
| Northwell Health- Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27104 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Santiago Reyes, M.D. | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Prisma Health Richland Campus | Columbia | South Carolina | 29203 | — |
| Sanford Children's Speciality Clinic | Sioux Falls | South Dakota | 57105 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8558 | — |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | — |
| University of Utah - Primary Children's Medical Center | Salt Lake City | Utah | 84132 | — |
| Vermont Lung Center | Colchester | Vermont | 05446 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Providence Pediatric Pulmonary & Cystic Fibrosis Clinic | Spokane | Washington | 99204 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| University Hospital and UW Health Clinics | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05076149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2024 · Synced Jun 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05076149 live on ClinicalTrials.gov.