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

PHASE3CompletedINTERVENTIONAL
Enrollment

597

Participants

Timeline

Start Date

October 27, 2021

Primary Completion Date

May 18, 2023

Study Completion Date

November 30, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-121/TEZ/D-IVA

Fixed-dose combination tablets for oral administration.

DRUG

ELX/TEZ/IVA

Fixed-dose combination tablets for oral administration.

DRUG

IVA

Tablet for oral administration.

DRUG

Placebo (matched to VX-121/TEZ/D-IVA)

Placebo matched to VX-121/TEZ/D-IVA for oral administration.

DRUG

Placebo (matched to ELX/TEZ/IVA)

Placebo matched to ELX/TEZ/IVA for oral administration.

DRUG

Placebo (matched to IVA)

Placebo matched to IVA for oral administration.

Trial Locations (170)

10032

Columbia University Medical Center, New York

11040

Northwell Health- Long Island Jewish Medical Center, New Hyde Park

13210

SUNY Upstate Medical University, Syracuse

14203

CF Therapeutics Development Center of Western New York, Buffalo

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

22908

University of Virginia Health System, Charlottesville

23507

Children's Hospital of the King's Daughters, Norfolk

26506

West Virginia University, Morgantown

27104

Wake Forest Baptist Health, Winston-Salem

29203

Prisma Health Richland Campus, Columbia

30324

The Emory Clinic at Chantilly, Atlanta

32207

Nemours Children's Specialty Care, Jacksonville

32514

Nemours Children's Specialty Care, Pensacola, Pensacola

32803

Central Florida Pulmonary Group, PA, Orlando

33136

University of Miami Miller School of Medicine, Miami

33701

Johns Hopkins All Children's Hospital Outpatient Care Center, St. Petersburg

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

37920

University of Tennessee Medical Center, Knoxville

39216

University of Mississippi Medical Center, Jackson

40536

University of Kentucky, Lexington

43205

Nationwide Children's Hospital, Columbus

43606

ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center, Toledo

44308

Akron Children's Hospital, Akron

45404

Dayton Children's Hospital, Dayton

46202

Indiana University, Indianapolis

Riley Hospital for Children at Indiana University Health, Indianapolis

48201

Harper University Hospital, Detroit

49546

Spectrum Health Medical Group Adult Cystic Fibrosis Care Center, Grand Rapids

53792

University Hospital and UW Health Clinics, Madison

57105

Sanford Children's Speciality Clinic, Sioux Falls

59101

Billings Clinic, Billings

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

Northwestern Memorial Hospital, Chicago

63110

Washington University School of Medicine, St Louis

64108

The Children's Mercy Hospital, Kansas City

70112

Tulane Medical Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73112

Santiago Reyes, M.D., Oklahoma City

76104

Cook Children's Health Care System, Fort Worth

80045

Children's Hospital of Colorado, Aurora

80206

National Jewish Health, Denver

83702

St. Luke's Cystic Fibrosis Center of Idaho, Boise

84132

University of Utah - Primary Children's Medical Center, Salt Lake City

85724

Banner University of Arizona Medical Center, Tucson

90027

Children's Hospital Los Angeles, Los Angeles

92868

Children's Hospital of Orange County, Orange

95817

University of California Davis Medical Center, Sacramento

97239

Oregon Health & Science University, Portland

98195

University of Washington Medical Center, Seattle

99204

Providence Pediatric Pulmonary & Cystic Fibrosis Clinic, Spokane

06510

Yale New Haven Hospital, New Haven

04102

Maine Medical Partners, Portland

02114

Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center, Boston

02115

Boston Children's Hospital, Boston

01655

UMass Memorial Medical Center, Worcester

48109-5212

Michigan Medicine, Ann Arbor

07960

Morristown Medical Center, Morristown

75390-8558

The University of Texas Southwestern Medical Center, Dallas

05446

Vermont Lung Center, Colchester

Unknown

Royal Prince Alfred Hospital, Camperdown

The Prince Charles Hospital, Chermside

Alfred Hospital, Melbourne, VIC

Institute for Respiratory Health, Nedlands

Telethon Kids Institute, Nedlands

The Royal Children's Hospital, Parkville, VIC

Sydney Children's Hospital, Randwick

Mater Adult Hospital, South Brisbane

Queensland Children's Hospital, South Brisbane

Westmead Hospital, Westmead

University of Graz, Graz

Medizinische Universität Innsbruck, Innsbruck

Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde, Salzburg

Medizinische Universität Wien, Vienna

Abteilung fuer Pulmologie Klinikum Wels-Grieskirchen, Wels

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

University of Calgary Medical Clinic of the Foothills Medical Centre, Calgary

Stollery Children's Hospital, Edmonton

St. Joseph's Health Care London, London

Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu, Montreal

McGill University Health Centre, Glen Site, Montreal Children's Hospital, Montreal

Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval, Québec

St. Michael's Hospital, Toronto

British Columbia Children's Hospital, Vancouver

St. Paul's Hospital, Vancouver

Aarhus University Hospital, Aarhus

Juliane Marie Center, Rigshospitalet, Copenhagen

Groupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux

CHU Lyon - Hopital Femme Mere-Enfant, Bron

Centre Hospitalier Intercommunal Creteil, Créteil

Institut Cœur Poumon, CHU de Lille, Lille

Hopital Arnaud de Villeneuve, Montpellier

Centre Hospitalier Universitaire De Nantes - G. R. Laennec, Nantes

Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur, Nice

Hopital Cochin, Paris

Hopital Necker, Enfants Malades, Paris

Hopital Robert Debre, Paris

Centre Hospitalier Lyon Sud, Pierre-Bénite

Centre de Perharidy, Roscoff

CHU de Rouen - Hopital Charles Nicolle, Rouen Cedex, Seine Maritime

Hôpital de Hautepierre, AX5, Strasbourg

Hopital Foch (Suresnes), Hopital Foch, Adultes, Suresnes

Hopital Bretonneau, Tours

Centre hospitalier universitaire de Nancy, Hôpital de Braboi, Vandœuvre-lès-Nancy

Charite Paediatric Pulmonology Department, Berlin

Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital, Erlangen

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie, Essen

Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin, Giessen

Pneumologisches Studienzentrum Muenchen-West, München

"General Hospital of Thessaloniki Papanikolaou", Pilea Chortiatis

General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki, Thessaloniki

National Koranyi Institute for TBC and Pulmonology, Budapest

Pulmonology Institute Torokbalint, Törökbálint

Cork University Hospital, Cork

Children's Health Ireland at Crumlin, Dublin

Children's Health Ireland at Tallaght, Dublin

Children's University Hospital, Dublin, Dublin

St. Vincent's University Hospital, Dublin

University Hospital Limerick (Adults), Limerick

University Hospital Limerick (Pediatrics), Limerick

Hadassah Medical Organization, Jerusalem

Schneider Children's Medical Center of Israel, Petach Tikvah

Sheba Medical Center - The Edmond and Lili Safra Children's Hospital, Tel Litwinsky

Azienda Ospedaliero Universitaria Ospedale Riuniti, Ancona

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer, Florence

IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico, Genova

Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica, Orbassano

Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo, Potenza

Azienda Ospedaliera di Verona - Ospedale Civile Maggiore, Verona

Academisch Medisch Centrum (Academic Medical Centre), Amsterdam

UMC St. Radboud, Nijmegen

Erasmus Medical Center, Rotterdam

HagaZiekenhuis van den Haag, The Hague

University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis, Utrecht

Greenlane Clinical Centre, Auckland

Starship Children's Hospital, Auckland

Canterbury Respiratory Research Group, Christchurch Hospital

Waikato Hospital, Hamilton

Haukeland Universitetssjukehus (CF), Bergen

Oslo University Hospital, Department of Paediatric Medicine, Oslo

Pediatric Hospital Polanki named of Maciej Płażyński, Gdansk

Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój

Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY, Łomianki

Sahlgrenska Universitetssjukhuset, Gothenburg

Lund University Skanes Universitetssjukhus, Malmo

Karolinska Universitetssjukhuset, Huddinge, Stockholm

Lindenhofspital - Quartier Bleu, Bern

Réseau Hospitalier Neuchâtelois, Neuchâtel

Kinderspital Zuerich, Zurich

Birmingham Children's Hospital, Birmingham

Royal Papworth Hospital NHS Foundation Trust, Cambridge

Clinical Research Facility, Queen Elizabeth University Hospital, Glasgow

Leeds General Infirmary, Leeds

St. James University Hospital, Leeds

King's College Hospital, London

Royal Brompton Hospital, London

St. Bartholomew's Hospital, London

Royal Manchester Children's Hospital, Manchester

Wythenshawe Hospital, Manchester

All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough, Penarth

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT05076149 - 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 | Biotech Hunter | Biotech Hunter