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Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451045
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

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, Europe, and Australia. 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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Lenabasum 20 mg Drug: Lenabasum 5 mg Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Lenabasum 20 mg BID Drug: Lenabasum 20 mg
Subjects will receive lenabasum 20 mg twice daily.

Experimental: Lenabasum 5 mg BID Drug: Lenabasum 5 mg
Subjects will receive lenabasum 5 mg twice daily.

Placebo Comparator: Placebo BID Other: Placebo
Subjects will receive placebo twice daily.




Primary Outcome Measures :
  1. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period.


Secondary Outcome Measures :
  1. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Event rate of PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo.

  2. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first new PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo.

  3. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first PEx using the secondary PEx definition with lenabasum 20 mg BID compared to placebo.

  4. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Event rate of PEx using the primary PEx definition with lenabasum 5 mg BID compared to placebo, during the treatment period.

  5. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Event rate of PEx using the secondary PEx definition with lenabasum 5 mg BID compared to placebo.

  6. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first new PEx using the primary PEx definition with lenabasum 5 mg BID compared to placebo.

  7. Pulmonary Exacerbation (PEx) [ Time Frame: Visit 1 through Week 28. ]
    Time to first PEx using the secondary PEx definition with lenabasum 5 mg BID compared to placebo.

  8. CFQ-R respiratory symptom domain [ Time Frame: Visit 1 through Week 28. ]
    Change from baseline in CFQ-R respiratory symptom domain with lenabasum compared to placebo.

  9. FEV1 % predicted [ Time Frame: Visit 1 through Week 28. ]
    Change from baseline in FEV1 % predicted with lenabasum compared to placebo.

  10. Adverse Events [ Time Frame: Visit 1 through Week 28. ]
    Incidence of treatment emergent adverse events with lenabasum treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451045


Contacts
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Contact: Lindsey Smith 617-977-5030 CFpatients@corbuspharma.com
Contact: Scott Constantine, MS 617-977-5030 CFpatients@corbuspharma.com

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Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Natalia Argel    602-933-0985      
Principal Investigator: Sophia Williams, MD         
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Kathleen Hicks    501-686-5527      
Principal Investigator: Larry Johnson, MD         
United States, California
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Roxana Flores    562-933-5607      
Principal Investigator: Cyrus Shahriary, MD         
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Christine Verano    303-398-1808      
Principal Investigator: Steven Lommatzsch, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Patricia Graham    305-243-5545      
Principal Investigator: Maria Gabriela Tupayachi Ortiz, MD         
Central Florida Pulmonary Group, PA Recruiting
Orlando, Florida, United States, 32803
Contact: Cynthia Schropp-Dyce    407-841-1100 ext 121      
Principal Investigator: Daniel Layish, MD         
Tampa General Hospital/USF Center for Advance Lung Disease Recruiting
Tampa, Florida, United States, 33606
Contact: Kristen Boyd    813-844-3543      
Principal Investigator: Kapilkumar Patel, MD         
United States, Georgia
Emory Children's Center Recruiting
Atlanta, Georgia, United States, 30322
Contact: Eric Hunter    404-727-7398      
Principal Investigator: Arlene Stecenko, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Rachel Nelson    312-695-0415      
Principal Investigator: Manu Jain, MD         
The Cystic Fibrosis Institute Recruiting
Glenview, Illinois, United States, 60025
Contact: Lorena Rosiles    847-998-3434      
Principal Investigator: Steven Boas, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Britany Zeglin    443-287-8983      
Principal Investigator: Natalie E West, MD, MHS         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Gootkind    617-726-3719      
Principal Investigator: Lael Yonker, MD         
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nicolas Fenton    617-355-6665      
Principal Investigator: Henry Dorkin, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center (main location) Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Barbara Rodgers    603-650-9718      
Principal Investigator: Alix Ashare, MD, PhD         
Dartmouth-Hitchcock Manchester (satellite site) Recruiting
Manchester, New Hampshire, United States, 03104
Contact: Dana Dorman    603-247-2821      
Principal Investigator: Alix Ashare, MD, PhD         
United States, New Jersey
Atlantic Health Children's Hospital Recruiting
Morristown, New Jersey, United States, 07960
Contact: Patricia Breitwieser    973-971-4142      
Principal Investigator: Arthur Atlas, MD         
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Nancy Martinez    973-971-5138      
Principal Investigator: Stanley Fiel, MD         
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Fei Chen, RN    732-235-5966      
Principal Investigator: Sabiha Hussain, MD         
United States, New York
New York Medical College Recruiting
Hawthorne, New York, United States, 10532
Contact: Armando Ramirez, LPN    914-593-8800      
Principal Investigator: Allen Dozor, MD         
North Shore LIJ Health System Recruiting
New Hyde Park, New York, United States, 11040
Contact: Andrea Sookchan    516-465-5412      
Principal Investigator: Janice Wang, MD         
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Contact: Anne Kukral    212-420-4100      
Principal Investigator: Patricia Walker, MD         
United States, Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cindy Shaefer, BSN, RN    216-286-0709      
Principal Investigator: Erica Roesch, MD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Terri Johnson    614-722-4756      
Principal Investigator: Karen McCoy, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Brendan Klein    503-418-8108      
Principal Investigator: Michael Powers, MD         
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Diane Kitch    717-531-5646      
Principal Investigator: Keith Randall Young, MD         
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Judy Hillman, RN    215-762-5462      
Principal Investigator: Michael Stephen, MD         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Carley McDowell    412-692-7044      
Principal Investigator: Joseph M Pilewski, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jill Spears    846-792-2072      
Principal Investigator: Patrick A Flume, MD         
United States, South Dakota
Sanford Children's Specialty Clinic Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Ashley Skidmore    605-328-1372      
Principal Investigator: James Wallace, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ashley Keller    214-648-2817      
Principal Investigator: Raksha Jain, MD         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Site Recruitment    682-885-6299      
Principal Investigator: Karen Schultz, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Chanei Henry    832-822-3389      
Principal Investigator: Tara Barto, MD         
The University of Texas Health Science Center at Tyler Recruiting
Tyler, Texas, United States, 75708
Contact: Elizabeth Dohanich    903-877-5435      
Principal Investigator: Rodolfo Amaro-Galvez, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jessica Francis    801-587-8105      
Principal Investigator: Theodore Liou, MD         
United States, Wisconsin
University Hospital and UW Health Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Sophia Chiron-Stevens    608-263-1244      
Principal Investigator: Andrew Braun, MD         
Austria
Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis Recruiting
Innsbruck, Austria
Contact: Nikelwa Theileis    4351250423592    nikelwa.theileis@i-med.ac.at   
Principal Investigator: Helmut Ellemunter, Dr         
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Christina Wittmann    4314040021480    christina.wittmann@meduniwien.ac.at   
Principal Investigator: Zsolt Szepfalusi         
Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium
Contact: Christel Van den Brande       Christel.VandenBrande@uzbrussel.be   
Principal Investigator: Elke De Wachter         
Bulgaria
Medical Center Prolet EOOD Recruiting
Ruse, Bulgaria
Contact: Svilen Dosev, MD    +359 888 885 988    dr.dosev@gmail.com   
Principal Investigator: Svilen Dosev, MD         
UMHAT Alexandrovska Recruiting
Sofia, Bulgaria
Contact: Guergana Petrova       gal_ps@yahoo.co.uk   
Principal Investigator: Guergana Petrova, Dr         
Canada
Centre hospitalier de l'Université de Montréal (CHUM) Recruiting
Montréal, Canada
Principal Investigator: Maïté Carricart, MD         
St. Michael's Hospital Recruiting
Toronto, Canada
Principal Investigator: Elizabeth Tullis, MD         
The Hospital for Sick Children Recruiting
Toronto, Canada
Principal Investigator: Felix Ratjen, MD         
St. Paul's Hospital Recruiting
Vancouver, Canada
Principal Investigator: Bradley Quon, MD         
Czechia
Motol University Hospital Recruiting
Praha, Czechia
Contact: Alena Bilkova    + 420 224 432 213      
Principal Investigator: Pavel Drevinek, MD, PhD         
France
Centre de Référence de la Mucoviscidose Recruiting
Bron, France
Principal Investigator: Catherine Mainguy, Dr         
Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant Recruiting
Bron, France
Contact: Philippe Reix, MD         
Principal Investigator: Philippe Reix, MD         
Hôpital Nord AP-HM Recruiting
Marseille, France
Principal Investigator: Nadine Dufeu, MD         
CHRU de Montpellier Recruiting
Montpellier, France
Principal Investigator: Raphaël Chiron, Dr         
CHU de Nice Recruiting
Nice, France
Principal Investigator: Sylvie Leroy, Dr         
Centre de Recherche en Explorations Fonctionnelles (CREF) Recruiting
Paris, France
Principal Investigator: Isabelle Fajac, Prof         
CRCM Hôpital Necker Recruiting
Paris, France
Principal Investigator: Isabelle Sermet-Gaudelus, MD         
Foundation ILDYS Recruiting
Roscoff, France
Contact: Jocelyne Pengam    330298293469    jocelyne.pengam@ildys.org   
Principal Investigator: Sophie Ramel, Dr         
Germany
Charité Universitätsmedzin Recruiting
Berlin, Germany
Contact: Doris Staab, MD    +49 (0)30 450 566 564    doris.staab@charite.de   
Principal Investigator: Doris Staab, MD         
Catholic Hospital Bochum - St. Josef-Hospital Recruiting
Bochum, Germany
Contact: Cordula Koerner-Rettberg, MD    0234-509-2693    Cordula.Koerner-Rettberg@rub.de   
Principal Investigator: Cordula Koerner-Rettberg, MD         
University Hospital Essen Recruiting
Essen, Germany
Contact: Florian Stehling, MD    +49 201 / 723-3350    florian.stehling@uk-essen.de   
Principal Investigator: Florian Stehling, MD         
University Medicine Essen Ruhrlandklinik Recruiting
Essen, Germany
Contact: Sivagurunathan Sutharsan, MD    0201/ 433-4503    sivagurunathan.sutharsan@rlk.uk-essen.de   
Principal Investigator: Sivagurunathan Sutharsan, MD         
Goethe University Children´s Hospital Recruiting
Frankfurt, Germany
Contact: Olaf Eickmeier, MD    +49 (0) 69-6301-83480      
Principal Investigator: Olaf Eickmeier, MD         
Hannover Medical School Recruiting
Hanover, Germany
Contact: Felix Ringshausen, MD    +49 511 532-3594    ringshausen.felix@mh-hannover.de   
Principal Investigator: Felix Ringshausen, MD         
University Hospital Jena Recruiting
Jena, Germany
Contact: Jochen Mainz, MD    +49 3641 9390842    jochen.mainz@med.uni-jena.de   
Principal Investigator: Jochen Mainz, MD         
Klinikum der Ludwig Maximilian Universität München Recruiting
München, Germany
Contact: Matthias Griese, MD       Matthias.griese@med.uni-muenchen.de   
Principal Investigator: Matthias Griese, MD         
Klinikum der Ludwig Maximilian Universität München Recruiting
München, Germany
Contact: Susanne Nährig, MD       susanne.naehrig@med.uni-muenchen.de   
Principal Investigator: Susanne Nährig, MD         
Greece
General Hospital of Attica Sismanoglio Recruiting
Athens, Greece
Contact: Filia Diamantea, Dr         
Principal Investigator: Filia Diamantea, Dr         
Hungary
National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis Recruiting
Budapest, Hungary
Contact: Adrien Halasz, MD    +36 30 743 5344    halaszadr@gmail.com   
Principal Investigator: Adrien Halasz, MD         
University of Debrecen - Kenezy Gyula University Hospital Recruiting
Debrecen, Hungary
Contact: Lilla Virag Szappanos       szappanos.lilla@kenezykorhaz.hu   
Principal Investigator: Ferenc Gönczi, MD         
Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged Recruiting
Kecskemét, Hungary
Contact: Olga Bede, MD       bedeolga@gmail.com   
Principal Investigator: Olga Bede, MD         
Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation Recruiting
Mosdós, Hungary
Contact: Gyöngyi Székely, MD       szekely.gyongyi@kmmk.hu   
Principal Investigator: Gyöngyi Székely, MD         
Pediatric Pulmonology, Törökbálint, Hungary Recruiting
Torokbalint, Hungary
Contact: Istvan Laki, MD    0036205795555    gyermektudo@gmail.com   
Principal Investigator: Istvan Laki, MD         
Italy
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica Recruiting
Firenze, Italy
Principal Investigator: Giovanni Taccetti, Dr         
U.O.S.D. - Centro fibrosi cistica Recruiting
Genova, Italy
Principal Investigator: Carlo Castellani, Prof         
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milano, Italy
Principal Investigator: Carla Colombo, Prof         
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Recruiting
Milano, Italy
Principal Investigator: Giovanna Pizzamiglio, MD         
Azienda Ospedaliera Universitaria Verona Recruiting
Verona, Italy
Principal Investigator: Paola Melotti, MD         
Netherlands
Radbound UMC Recruiting
Nijmegen, Netherlands
Principal Investigator: Dr Merkus         
Poland
Podkarpacki Osrodek Pulmonologii i Alergologii Recruiting
Rzeszów, Poland
Contact: Marta Rachel, MD         
Principal Investigator: Marta Rachel, MD         
Portugal
Hospital de Santa Maria Recruiting
Lisboa, Portugal
Principal Investigator: Pilar Azevedo, MD         
Hospital de Santa Maria Recruiting
Lisboa, Portugal
Principal Investigator: Celeste Barreto, Prof         
Russian Federation
National Medical Research Center of Children's Health Recruiting
Moscow, Russian Federation
Contact: Yulia Gorinova       ygorinova@yandex.ru   
Principal Investigator: Olga Simonova         
Scientfic Research Institute of Pulmonology Recruiting
Moscow, Russian Federation
Contact: Stanislav Krasovsky       sa_krasovsky@mail.ru   
Contact: Elena Amelina       eamelina@mail.ru   
Principal Investigator: Elena Amelina         
Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology Recruiting
Mytishchi, Russian Federation
Contact: Anna Voronkova       voronkova111@yandex.ru   
Principal Investigator: Elena Kondratyeva         
Children's City Hospital of Saint Olga Recruiting
Saint Petersburg, Russian Federation
Contact: Taras Borisenko       borisenko_taras@mail.ru   
Contact: Aleksandr Orlov       orlovcf@yandex.ru   
Sub-Investigator: Taras Borisenko         
Principal Investigator: Aleksandr Orlov         
First St. Petersburg State Pavlov Medical University Recruiting
St. Petersburg, Russian Federation
Contact: Aleksei Chermenskii       Tchermenski@mail.ru   
Contact: Mikhail Ilkovich       mih.ilkovich@yandex.ru   
Principal Investigator: Mikhail Ilkovich         
Serbia
Clinical for Pulmonary Diseases, Clinical Center of Serbia Recruiting
Belgrade, Serbia
Contact: Jelena Cvejic    +381637613449    cvejicjelena03@gmail.com   
Principal Investigator: Branislava Milenkovic, MD         
Institute for Child and Youth Health Care of Vojvodina Recruiting
Novi Sad, Serbia
Contact: Gordana Vilotijevic Dautovic, PhD, MD    +381637706265    vilotijevic.dautovic@gmail.com   
Principal Investigator: Gordana Vilotijevic Dautovic, PhD, MD         
Institute for Pulmonary Disease of Vojvodina Recruiting
Sremska Kamenica, Serbia
Contact: Mirna Djuric    0656476235    mirnadjuric@yahoo.com   
Principal Investigator: Mirna Djuric, Prof         
Slovakia
Children's faculty hospital with polyclinic Banska Bystrica Recruiting
Banská Bystrica, Slovakia
Contact: Branko Takac, MD    00421905138180    btakac@dfnbb.sk   
Principal Investigator: Branko Takac, MD         
Children's Faculty Hospital Kosice Recruiting
Košice, Slovakia
Contact: Anna Feketeova, Dr         
Principal Investigator: Anna Feketeova, Dr         
Spain
Unidad de Fibrosis Quistica Adultos Recruiting
Barcelona, Spain
Principal Investigator: Antonio Alvarez, Dr         
Unidad de Fibrosis Quistica Pediatria Recruiting
Barcelona, Spain
Principal Investigator: Silvia Gartner, Dra         
Unidad de Fibrosis Quistica y Transplante Pulmonar Recruiting
Valencia, Spain
Principal Investigator: Amparo Solé, Dra         
Sweden
Skane University Hospital Recruiting
Lund, Sweden
Contact: Ulrika Lindberg    +46(0)46171450    ulrika.lindberg@skane.se   
Principal Investigator: Lennart Hansson, MD, PhD         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Lena Hjelte       lena.hjelte@sll.se   
Principal Investigator: Lena Hjelte, MD, PhD         
United Kingdom
Liverpool Heart and Chest Hospital Recruiting
Liverpool, Merseyside, United Kingdom
Contact: Sharon Burnett       Sharon.burnett@lhch.nhs.uk   
Contact: Marie Preidt       marie.preidt@lhch.nhs.uk   
Principal Investigator: James Greenwood, MD         
Belfast City Hospital Recruiting
Belfast, Northern Ireland, United Kingdom
Contact: Roisin Stone       roisin.stone@belfasttrust.hscni.net   
Contact: Ryan Leslie       ryan.leslie@belfasttrust.hscni.net   
Principal Investigator: Damian Downey, MD         
Queen's Medical Centre Recruiting
Nottingham, Nottinghamshire, United Kingdom
Contact: Jessica Longmate       jessica.longmate@nuh.nhs.uk   
Principal Investigator: Alan Smyth, MD         
Birmingham Women's and Children's NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Contact: Maya Desai, MD    0121 333 8202    maya.desai@nhs.net   
Principal Investigator: Maya Desai, MD         
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Contact: Joanna Whitehouse, MD    0121 424 2000 ext 41746    joanna.whitehouse@heartofengland.nhs.uk   
Principal Investigator: Joanna Whitehouse, MD         
Royal Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, United Kingdom
Contact: Charles Haworth, MD    01480 364 495    charles.haworth@nhs.net   
Principal Investigator: Charles Haworth, MD         
Cardiff and Vale University Health Board Recruiting
Llandough, United Kingdom
Contact: Jamie Duckers, MD    02920 715040    jamie.duckers@wales.nhs.uk   
Principal Investigator: Jamie Duckers, MD         
Barts Health NHS Trust Recruiting
London, United Kingdom
Contact: Kat Miles    0203 465 5252    kat.miles@bartshealth.nhs.uk   
Principal Investigator: Danie Watson, MD         
Royal Brompton & Harefield NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Andrew Jones, MD    020 7352 8121 x84245    A.Jones2@rbht.nhs.uk   
Principal Investigator: Andrew Jones, MD         
Wolfson Cystic Fibrosis Centre City Hospital Campus Recruiting
Nottingham, United Kingdom
Contact: Jessica Longmate       jessica.longmate@nuh.nhs.uk   
Principal Investigator: Helen Barr, PhD         
University Hospital Southampton NHS Foundation Trust Recruiting
Southampton, United Kingdom
Contact: Mary Carroll, MD    023 8120 5371    mary.carroll@uhs.nhs.uk   
Principal Investigator: Mary Carroll, MD         
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: James Chmiel, MD Rainbow Baby and Children's Hospital
Principal Investigator: J. Stuart Elborn, MD National Heart and Lung Institute, Imperial College

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Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03451045     History of Changes
Other Study ID Numbers: JBT101-CF-002
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corbus Pharmaceuticals Inc.:
Pulmonary exacerbation, lenabasum, JBT-101
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases