Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
NCT ID: NCT03451045
Last Updated: 2023-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
447 participants
INTERVENTIONAL
2017-12-22
2020-06-17
Brief Summary
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Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lenabasum 20 mg BID
Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.
Lenabasum 5 mg BID
Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.
Placebo BID
Placebo
Subjects will receive placebo twice daily.
Interventions
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Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.
Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.
Placebo
Subjects will receive placebo twice daily.
Eligibility Criteria
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Inclusion Criteria
2. Weight ≥ 40 kg.
3. FEV1 ≥ 40% predicted and \< 100% predicted in the last 12 months.
4. Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.
Exclusion Criteria
2. Any of the following values for laboratory tests at screening:
1. A positive pregnancy test.
2. Hemoglobin \< 10 g/dL in males and \< 9 g/dL in females.
3. Neutrophils \< 1.0 x 10\^9 /L.
4. Platelets \< 75 x 10\^9/L.
5. Creatinine clearance \< 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
6. Serum transaminases \> 2.5 x upper limit of normal.
3. Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
12 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Corbus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Chmiel, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine/Riley Physicians Pulmonary
J. Stuart Elborn, MD
Role: PRINCIPAL_INVESTIGATOR
National Heart and Lung Institute, Imperial College
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Miller Children's Hospital
Long Beach, California, United States
National Jewish Health
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, United States
USF Center for Advance Lung Disease
Tampa, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The Cystic Fibrosis Institute
Glenview, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center (main location)
Lebanon, New Hampshire, United States
Dartmouth-Hitchcock Manchester (satellite site)
Manchester, New Hampshire, United States
Atlantic Health Children's Hospital
Morristown, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
New York Medical College
Hawthorne, New York, United States
North Shore LIJ Health System
New Hyde Park, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Milton S. Hershey Medical Center / Penn State College of Medicine
Hershey, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, United States
Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis
Innsbruck, , Austria
Medical University of Vienna
Vienna, , Austria
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Medical Center Prolet EOOD
Rousse, , Bulgaria
UMHAT Alexandrovska
Sofia, , Bulgaria
MHAT Sveta Marina EAD
Varna, , Bulgaria
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, , Canada
St. Michael's Hospital
Toronto, , Canada
The Hospital for Sick Children
Toronto, , Canada
St. Paul's Hospital
Vancouver, , Canada
Motol University Hospital
Prague, , Czechia
Centre de Référence de la Mucoviscidose
Bron, , France
Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant
Bron, , France
Service de Pediatrie Medico-Chirurgicale et Genetique
Dijon, , France
CHRU de Montpellier
Montpellier, , France
CRCM Enfant de Nancy
Nancy, , France
CHU de Nice
Nice, , France
Centre de Recherche en Explorations Fonctionnelles (CREF)
Paris, , France
CRCM Hôpital Necker
Paris, , France
Foundation ILDYS
Roscoff, , France
Nouvel Hopital Civil Strasbourg
Strasbourg, , France
Charité Universitätsmedzin
Berlin, , Germany
Catholic Hospital Bochum - St. Josef-Hospital
Bochum, , Germany
University Hospital Essen
Essen, , Germany
University Medicine Essen Ruhrlandklinik
Essen, , Germany
Goethe University Children´s Hospital
Frankfurt, , Germany
Hannover Medical School
Hanover, , Germany
University Hospital Jena
Jena, , Germany
Klinikum der Ludwig Maximilian Universität München
München, , Germany
General Hospital of Thessaloniki Ippokratio
Thessaloniki, , Greece
National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis
Budapest, , Hungary
University of Debrecen - Kenezy Gyula University Hospital
Debrecen, , Hungary
Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged
Kecskemét, , Hungary
Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation
Mosdós, , Hungary
Pediatric Pulmonology, Törökbálint, Hungary
Törökbálint, , Hungary
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
Florence, , Italy
U.O.S.D. - Centro fibrosi cistica
Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Verona
Verona, , Italy
Radbound UMC
Nijmegen, , Netherlands
Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc
Dziekanów Leśny, , Poland
Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy
Gdansk, , Poland
Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow
Rabka-Zdrój, , Poland
Institute for Mother and Child, Department of CF for Children's and Youth
Rzeszów, , Poland
Hospital de Santa Maria
Lisbon, , Portugal
Medial Center for Ambulatory Diagnosis and Treatment
Brasov, , Romania
Scientfic Research Institute of Pulmonology
Moscow, , Russia
Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology
Mytishchi, , Russia
Children's City Hospital of Saint Olga
Saint Petersburg, , Russia
First St. Petersburg State Pavlov Medical University
Saint Petersburg, , Russia
Clinical for Pulmonary Diseases, Clinical Center of Serbia
Belgrade, , Serbia
Institute for Pulmonary Disease of Vojvodina
Kamenitz, , Serbia
Institute for Child and Youth Health Care of Vojvodina
Novi Sad, , Serbia
Children's faculty hospital with polyclinic Banska Bystrica
Banská Bystrica, , Slovakia
Children's Faculty Hospital Kosice
Košice, , Slovakia
Unidad de Fibrosis Quistica Adultos
Barcelona, , Spain
Unidad de Fibrosis Quistica Pediatria
Barcelona, , Spain
Unidad de Fibrosis Quistica y Transplante Pulmonar
Valencia, , Spain
Skane University Hospital
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Cardiff and Vale University Health Board
Llandough, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, , United Kingdom
Wolfson Cystic Fibrosis Centre City Hospital Campus
Nottingham, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JBT101-CF-002
Identifier Type: -
Identifier Source: org_study_id
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