Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

PHASE2CompletedINTERVENTIONAL
Enrollment

447

Participants

Timeline

Start Date

December 22, 2017

Primary Completion Date

June 17, 2020

Study Completion Date

June 17, 2020

Conditions
Cystic Fibrosis
Interventions
DRUG

Lenabasum 20 mg

Subjects will receive lenabasum 20 mg twice daily.

DRUG

Lenabasum 5 mg

Subjects will receive lenabasum 5 mg twice daily.

OTHER

Placebo

Subjects will receive placebo twice daily.

Trial Locations (105)

10003

Mount Sinai Beth Israel, New York

10532

New York Medical College, Hawthorne

11040

North Shore LIJ Health System, New Hyde Park

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

17033

Milton S. Hershey Medical Center / Penn State College of Medicine, Hershey

19102

Drexel University College of Medicine, Philadelphia

21205

Johns Hopkins University, Baltimore

29425

Medical University of South Carolina, Charleston

30322

Emory Children's Center, Atlanta

32803

Central Florida Pulmonary Group, PA, Orlando

33136

University of Miami, Miami

33606

USF Center for Advance Lung Disease, Tampa

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland

53792

University Hospital and UW Health Clinics, Madison

57105

Sanford Children's Specialty Clinic, Sioux Falls

60025

The Cystic Fibrosis Institute, Glenview

60611

Northwestern Memorial Hospital, Chicago

72205

University of Arkansas for Medical Sciences, Little Rock

75390

UT Southwestern Medical Center, Dallas

75708

The University of Texas Health Science Center at Tyler, Tyler

76104

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital, Houston

80206

National Jewish Health, Denver

84132

University of Utah, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

90806

Miller Children's Hospital, Long Beach

97239

Oregon Health and Science University, Portland

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

03756

Dartmouth-Hitchcock Medical Center (main location), Lebanon

03104

Dartmouth-Hitchcock Manchester (satellite site), Manchester

07960

Atlantic Health Children's Hospital, Morristown

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

Unknown

Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis, Innsbruck

Medical University of Vienna, Vienna

Universitair Ziekenhuis Brussel, Brussels

Medical Center Prolet EOOD, Rousse

UMHAT Alexandrovska, Sofia

MHAT Sveta Marina EAD, Varna

Centre hospitalier de l'Université de Montréal (CHUM), Montreal

St. Michael's Hospital, Toronto

The Hospital for Sick Children, Toronto

St. Paul's Hospital, Vancouver

Motol University Hospital, Prague

Centre de Référence de la Mucoviscidose, Bron

Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant, Bron

Service de Pediatrie Medico-Chirurgicale et Genetique, Dijon

CHRU de Montpellier, Montpellier

CRCM Enfant de Nancy, Nancy

CHU de Nice, Nice

Centre de Recherche en Explorations Fonctionnelles (CREF), Paris

CRCM Hôpital Necker, Paris

Foundation ILDYS, Roscoff

Nouvel Hopital Civil Strasbourg, Strasbourg

Charité Universitätsmedzin, Berlin

Catholic Hospital Bochum - St. Josef-Hospital, Bochum

University Hospital Essen, Essen

University Medicine Essen Ruhrlandklinik, Essen

Goethe University Children´s Hospital, Frankfurt

Hannover Medical School, Hanover

University Hospital Jena, Jena

Klinikum der Ludwig Maximilian Universität München, München

General Hospital of Thessaloniki Ippokratio, Thessaloniki

National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis, Budapest

University of Debrecen - Kenezy Gyula University Hospital, Debrecen

Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged, Kecskemét

Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation, Mosdós

Pediatric Pulmonology, Törökbálint, Hungary, Törökbálint

Centro Regionale Toscano di Riferimento per la Fibrosi Cistica, Florence

U.O.S.D. - Centro fibrosi cistica, Genova

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan

Azienda Ospedaliera Universitaria Verona, Verona

Radbound UMC, Nijmegen

Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy, Gdansk

Institute for Mother and Child, Department of CF for Children's and Youth, Rzeszów

Hospital de Santa Maria, Lisbon

Medial Center for Ambulatory Diagnosis and Treatment, Brasov

Scientfic Research Institute of Pulmonology, Moscow

Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology, Mytishchi

Children's City Hospital of Saint Olga, Saint Petersburg

First St. Petersburg State Pavlov Medical University, Saint Petersburg

Clinical for Pulmonary Diseases, Clinical Center of Serbia, Belgrade

Institute for Pulmonary Disease of Vojvodina, Kamenitz

Institute for Child and Youth Health Care of Vojvodina, Novi Sad

Children's faculty hospital with polyclinic Banska Bystrica, Banská Bystrica

Children's Faculty Hospital Kosice, Košice

Unidad de Fibrosis Quistica Adultos, Barcelona

Unidad de Fibrosis Quistica Pediatria, Barcelona

Unidad de Fibrosis Quistica y Transplante Pulmonar, Valencia

Skane University Hospital, Lund

Karolinska University Hospital, Stockholm

Liverpool Heart and Chest Hospital, Liverpool

Belfast City Hospital, Belfast

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

University Hospitals Birmingham NHS Foundation Trust, Birmingham

Royal Papworth Hospital NHS Foundation Trust, Cambridge

Cardiff and Vale University Health Board, Llandough

Barts Health NHS Trust, London

Royal Brompton & Harefield NHS Foundation Trust, London

Wolfson Cystic Fibrosis Centre City Hospital Campus, Nottingham

University Hospital Southampton NHS Foundation Trust, Southampton

05-092

Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc, Dziekanów Leśny

34-700

Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow, Rabka-Zdrój

Sponsors
All Listed Sponsors
collaborator

Cystic Fibrosis Foundation

OTHER

lead

Corbus Pharmaceuticals Inc.

INDUSTRY

NCT03451045 - Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis | Biotech Hunter | Biotech Hunter