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Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lenabasum 20 mg
Lenabasum 5 mg
Placebo
Sponsored by
Corbus Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Pulmonary exacerbation, lenabasum, JBT-101

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.
  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:

  1. Severe or unstable CF at screening or Visit 1.

  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.

Sites / Locations

  • Phoenix Children's Hospital
  • University of Arkansas for Medical Sciences
  • Miller Children's Hospital
  • National Jewish Health
  • University of Miami
  • Central Florida Pulmonary Group, PA
  • USF Center for Advance Lung Disease
  • Emory Children's Center
  • Northwestern Memorial Hospital
  • The Cystic Fibrosis Institute
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Boston Children's Hospital
  • Dartmouth-Hitchcock Medical Center (main location)
  • Dartmouth-Hitchcock Manchester (satellite site)
  • Atlantic Health Children's Hospital
  • Rutgers Robert Wood Johnson Medical School
  • New York Medical College
  • North Shore LIJ Health System
  • Mount Sinai Beth Israel
  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
  • Nationwide Children's Hospital
  • Oregon Health and Science University
  • Milton S. Hershey Medical Center / Penn State College of Medicine
  • Drexel University College of Medicine
  • Children's Hospital of Pittsburgh of UPMC
  • Medical University of South Carolina
  • Sanford Children's Specialty Clinic
  • UT Southwestern Medical Center
  • Cook Children's Medical Center
  • Texas Children's Hospital
  • The University of Texas Health Science Center at Tyler
  • University of Utah
  • University Hospital and UW Health Clinics
  • Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis
  • Medical University of Vienna
  • Universitair Ziekenhuis Brussel
  • Medical Center Prolet EOOD
  • UMHAT Alexandrovska
  • MHAT Sveta Marina EAD
  • Centre hospitalier de l'Université de Montréal (CHUM)
  • St. Michael's Hospital
  • The Hospital for Sick Children
  • St. Paul's Hospital
  • Motol University Hospital
  • Centre de Référence de la Mucoviscidose
  • Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant
  • Service de Pediatrie Medico-Chirurgicale et Genetique
  • CHRU de Montpellier
  • CRCM Enfant de Nancy
  • CHU de Nice
  • Centre de Recherche en Explorations Fonctionnelles (CREF)
  • CRCM Hôpital Necker
  • Foundation ILDYS
  • Nouvel Hopital Civil Strasbourg
  • Charité Universitätsmedzin
  • Catholic Hospital Bochum - St. Josef-Hospital
  • University Hospital Essen
  • University Medicine Essen Ruhrlandklinik
  • Goethe University Children´s Hospital
  • Hannover Medical School
  • University Hospital Jena
  • Klinikum der Ludwig Maximilian Universität München
  • General Hospital of Thessaloniki Ippokratio
  • National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis
  • University of Debrecen - Kenezy Gyula University Hospital
  • Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged
  • Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation
  • Pediatric Pulmonology, Törökbálint, Hungary
  • Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
  • U.O.S.D. - Centro fibrosi cistica
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Azienda Ospedaliera Universitaria Verona
  • Radbound UMC
  • Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc
  • Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy
  • Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow
  • Institute for Mother and Child, Department of CF for Children's and Youth
  • Hospital de Santa Maria
  • Medial Center for Ambulatory Diagnosis and Treatment
  • Scientfic Research Institute of Pulmonology
  • Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology
  • Children's City Hospital of Saint Olga
  • First St. Petersburg State Pavlov Medical University
  • Clinical for Pulmonary Diseases, Clinical Center of Serbia
  • Institute for Child and Youth Health Care of Vojvodina
  • Institute for Pulmonary Disease of Vojvodina
  • Children's faculty hospital with polyclinic Banska Bystrica
  • Children's Faculty Hospital Kosice
  • Unidad de Fibrosis Quistica Adultos
  • Unidad de Fibrosis Quistica Pediatria
  • Unidad de Fibrosis Quistica y Transplante Pulmonar
  • Skane University Hospital
  • Karolinska University Hospital
  • Liverpool Heart and Chest Hospital
  • Belfast City Hospital
  • Birmingham Women's and Children's NHS Foundation Trust
  • University Hospitals Birmingham NHS Foundation Trust
  • Royal Papworth Hospital NHS Foundation Trust
  • Cardiff and Vale University Health Board
  • Barts Health NHS Trust
  • Royal Brompton & Harefield NHS Foundation Trust
  • Wolfson Cystic Fibrosis Centre City Hospital Campus
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Lenabasum 20 mg BID

Lenabasum 5 mg BID

Placebo BID

Arm Description

Outcomes

Primary Outcome Measures

Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.

Secondary Outcome Measures

Pulmonary Exacerbation (PEx) Rate
Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks
Time to First New Pulmonary Exacerbation (PEx)
Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit
Pulmonary Exacerbation (PEx)
Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx.
CFQ-R Respiratory Symptom Domain
Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects >/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
FEV1 % Predicted
Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants.

Full Information

First Posted
February 23, 2018
Last Updated
December 21, 2022
Sponsor
Corbus Pharmaceuticals Inc.
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03451045
Brief Title
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
June 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corbus Pharmaceuticals Inc.
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks. Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Pulmonary exacerbation, lenabasum, JBT-101

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenabasum 20 mg BID
Arm Type
Experimental
Arm Title
Lenabasum 5 mg BID
Arm Type
Experimental
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lenabasum 20 mg
Intervention Description
Subjects will receive lenabasum 20 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Lenabasum 5 mg
Intervention Description
Subjects will receive lenabasum 5 mg twice daily.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo twice daily.
Primary Outcome Measure Information:
Title
Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
Description
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
Time Frame
28 weeks (Baseline Day 0 to Week 28)
Secondary Outcome Measure Information:
Title
Pulmonary Exacerbation (PEx) Rate
Description
Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx. The PEx rate is calculated as the number of PEx/28 weeks
Time Frame
28 weeks (Baseline Day 0 to Week 28)
Title
Time to First New Pulmonary Exacerbation (PEx)
Description
Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx. The rate is calculate over a 28 week period from visit 1 to week 28 visit
Time Frame
28 weeks (Baseline Day 0 to Week 28)
Title
Pulmonary Exacerbation (PEx)
Description
Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo. The secondary definition of a PEx is based on the physician's diagnosis of pulmonary exacerbation and commencement of new oral, intravenous, or inhaled antibiotics. A new PEx is defined one that starts 28 or more days after the previous confirmed PEx.
Time Frame
28 weeks (Baseline Day 0 to Week 28)
Title
CFQ-R Respiratory Symptom Domain
Description
Cystic Fibrosis Questionnaire - Revised measures change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo. Subjects >/= 14 years of age. 5 distinct 4-point Likert scales (e.g., always/often/ sometime/never) Scores for each HRQoL domain; after recoding, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Time Frame
28 weeks (Change from Baseline Day 0 to Week 28)
Title
FEV1 % Predicted
Description
Change from baseline to week 28 in Forced Expiratory Volume in 1 second (FEV1) expressed as a percentage of a normal range. A lower percentage FEV1 is indicative of decrease in lung functionality. The changes observed from baseline to week 28 for lenabasum will be compared with those observed for placebo treated participants.
Time Frame
28 weeks (Change from Baseline Day 0 to Week 28)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 12 years of age at the time Informed Consent/ Assent is signed. Weight ≥ 40 kg. FEV1 ≥ 40% predicted and < 100% predicted in the last 12 months. 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: Severe or unstable CF at screening or Visit 1. Any of the following values for laboratory tests at screening: A positive pregnancy test. Hemoglobin < 10 g/dL in males and < 9 g/dL in females. Neutrophils < 1.0 x 10^9 /L. Platelets < 75 x 10^9/L. Creatinine clearance < 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation. Serum transaminases > 2.5 x upper limit of normal. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Chmiel, MD
Organizational Affiliation
Indiana University School of Medicine/Riley Physicians Pulmonary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Stuart Elborn, MD
Organizational Affiliation
National Heart and Lung Institute, Imperial College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
USF Center for Advance Lung Disease
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Cystic Fibrosis Institute
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center (main location)
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dartmouth-Hitchcock Manchester (satellite site)
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104
Country
United States
Facility Name
Atlantic Health Children's Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York Medical College
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
North Shore LIJ Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Milton S. Hershey Medical Center / Penn State College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanford Children's Specialty Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University Hospital and UW Health Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis
City
Innsbruck
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Medical Center Prolet EOOD
City
Ruse
Country
Bulgaria
Facility Name
UMHAT Alexandrovska
City
Sofia
Country
Bulgaria
Facility Name
MHAT Sveta Marina EAD
City
Varna
Country
Bulgaria
Facility Name
Centre hospitalier de l'Université de Montréal (CHUM)
City
Montréal
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
Country
Canada
Facility Name
Motol University Hospital
City
Praha
Country
Czechia
Facility Name
Centre de Référence de la Mucoviscidose
City
Bron
Country
France
Facility Name
Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant
City
Bron
Country
France
Facility Name
Service de Pediatrie Medico-Chirurgicale et Genetique
City
Dijon
Country
France
Facility Name
CHRU de Montpellier
City
Montpellier
Country
France
Facility Name
CRCM Enfant de Nancy
City
Nancy
Country
France
Facility Name
CHU de Nice
City
Nice
Country
France
Facility Name
Centre de Recherche en Explorations Fonctionnelles (CREF)
City
Paris
Country
France
Facility Name
CRCM Hôpital Necker
City
Paris
Country
France
Facility Name
Foundation ILDYS
City
Roscoff
Country
France
Facility Name
Nouvel Hopital Civil Strasbourg
City
Strasbourg
Country
France
Facility Name
Charité Universitätsmedzin
City
Berlin
Country
Germany
Facility Name
Catholic Hospital Bochum - St. Josef-Hospital
City
Bochum
Country
Germany
Facility Name
University Hospital Essen
City
Essen
Country
Germany
Facility Name
University Medicine Essen Ruhrlandklinik
City
Essen
Country
Germany
Facility Name
Goethe University Children´s Hospital
City
Frankfurt
Country
Germany
Facility Name
Hannover Medical School
City
Hanover
Country
Germany
Facility Name
University Hospital Jena
City
Jena
Country
Germany
Facility Name
Klinikum der Ludwig Maximilian Universität München
City
München
Country
Germany
Facility Name
General Hospital of Thessaloniki Ippokratio
City
Thessaloníki
Country
Greece
Facility Name
National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis
City
Budapest
Country
Hungary
Facility Name
University of Debrecen - Kenezy Gyula University Hospital
City
Debrecen
Country
Hungary
Facility Name
Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged
City
Kecskemét
Country
Hungary
Facility Name
Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation
City
Mosdós
Country
Hungary
Facility Name
Pediatric Pulmonology, Törökbálint, Hungary
City
Torokbalint
Country
Hungary
Facility Name
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
City
Firenze
Country
Italy
Facility Name
U.O.S.D. - Centro fibrosi cistica
City
Genova
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Verona
City
Verona
Country
Italy
Facility Name
Radbound UMC
City
Nijmegen
Country
Netherlands
Facility Name
Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc
City
Dziekanow Lesny
ZIP/Postal Code
05-092
Country
Poland
Facility Name
Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy
City
Gdańsk
Country
Poland
Facility Name
Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow
City
Rabka-Zdrój
ZIP/Postal Code
34-700
Country
Poland
Facility Name
Institute for Mother and Child, Department of CF for Children's and Youth
City
Rzeszów
Country
Poland
Facility Name
Hospital de Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Medial Center for Ambulatory Diagnosis and Treatment
City
Braşov
Country
Romania
Facility Name
Scientfic Research Institute of Pulmonology
City
Moscow
Country
Russian Federation
Facility Name
Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology
City
Mytishchi
Country
Russian Federation
Facility Name
Children's City Hospital of Saint Olga
City
Saint Petersburg
Country
Russian Federation
Facility Name
First St. Petersburg State Pavlov Medical University
City
St. Petersburg
Country
Russian Federation
Facility Name
Clinical for Pulmonary Diseases, Clinical Center of Serbia
City
Belgrade
Country
Serbia
Facility Name
Institute for Child and Youth Health Care of Vojvodina
City
Novi Sad
Country
Serbia
Facility Name
Institute for Pulmonary Disease of Vojvodina
City
Sremska Kamenica
Country
Serbia
Facility Name
Children's faculty hospital with polyclinic Banska Bystrica
City
Banská Bystrica
Country
Slovakia
Facility Name
Children's Faculty Hospital Kosice
City
Košice
Country
Slovakia
Facility Name
Unidad de Fibrosis Quistica Adultos
City
Barcelona
Country
Spain
Facility Name
Unidad de Fibrosis Quistica Pediatria
City
Barcelona
Country
Spain
Facility Name
Unidad de Fibrosis Quistica y Transplante Pulmonar
City
Valencia
Country
Spain
Facility Name
Skane University Hospital
City
Lund
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
State/Province
Merseyside
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
Country
United Kingdom
Facility Name
Birmingham Women's and Children's NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Cardiff and Vale University Health Board
City
Llandough
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
Country
United Kingdom
Facility Name
Royal Brompton & Harefield NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Wolfson Cystic Fibrosis Centre City Hospital Campus
City
Nottingham
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

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