Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

December 21, 2022 updated by: Corbus Pharmaceuticals Inc.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
447

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis
      • Vienna, Austria
        • Medical University of Vienna
  • Belgium
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
  • Bulgaria
      • Ruse, Bulgaria
        • Medical Center Prolet Eood
      • Sofia, Bulgaria
        • UMHAT Alexandrovska
      • Varna, Bulgaria
        • MHAT Sveta Marina EAD
  • Canada
      • Montréal, Canada
        • Centre hospitalier de l'Université de Montréal (CHUM)
      • Toronto, Canada
        • The Hospital for Sick Children
      • Toronto, Canada
        • St. Michael's Hospital
      • Vancouver, Canada
        • St. Paul's Hospital
  • Czechia
      • Praha, Czechia
        • Motol University Hospital
  • France
      • Bron, France
        • Centre de Référence de la Mucoviscidose
      • Bron, France
        • Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant
      • Dijon, France
        • Service de Pediatrie Medico-Chirurgicale et Genetique
      • Montpellier, France
        • CHRU de Montpellier
      • Nancy, France
        • CRCM Enfant de Nancy
      • Nice, France
        • CHU de Nice
      • Paris, France
        • Centre de Recherche en Explorations Fonctionnelles (CREF)
      • Paris, France
        • CRCM Hôpital Necker
      • Roscoff, France
        • Foundation ILDYS
      • Strasbourg, France
        • Nouvel Hôpital Civil Strasbourg
  • Germany
      • Berlin, Germany
        • Charité Universitätsmedzin
      • Bochum, Germany
        • Catholic Hospital Bochum - St. Josef-Hospital
      • Essen, Germany
        • University Hospital Essen
      • Essen, Germany
        • University Medicine Essen Ruhrlandklinik
      • Frankfurt, Germany
        • Goethe University Children´s Hospital
      • Hanover, Germany
        • Hannover Medical School
      • Jena, Germany
        • University Hospital Jena
      • München, Germany
        • Klinikum der Ludwig Maximilian Universität München
  • Greece
      • Thessaloníki, Greece
        • General Hospital of Thessaloniki Ippokratio
  • Hungary
      • Budapest, Hungary
        • National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis
      • Debrecen, Hungary
        • University of Debrecen - Kenezy Gyula University Hospital
      • Kecskemét, Hungary
        • Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged
      • Mosdós, Hungary
        • Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation
      • Torokbalint, Hungary
        • Pediatric Pulmonology, Törökbálint, Hungary
  • Italy
      • Firenze, Italy
        • Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
      • Genova, Italy
        • U.O.S.D. - Centro fibrosi cistica
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Verona
  • Netherlands
      • Nijmegen, Netherlands
        • Radbound UMC
  • Poland
      • Dziekanow Lesny, Poland, 05-092
        • Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc
      • Gdańsk, Poland
        • Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy
      • Rabka-Zdrój, Poland, 34-700
        • Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow
      • Rzeszów, Poland
        • Institute for Mother and Child, Department of CF for Children's and Youth
  • Portugal
      • Lisboa, Portugal
        • Hospital de Santa Maria
  • Romania
      • Braşov, Romania
        • Medial Center for Ambulatory Diagnosis and Treatment
  • Russian Federation
      • Moscow, Russian Federation
        • Scientfic Research Institute of Pulmonology
      • Mytishchi, Russian Federation
        • Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology
      • Saint Petersburg, Russian Federation
        • Children's City Hospital of Saint Olga
      • St. Petersburg, Russian Federation
        • First St. Petersburg State Pavlov Medical University
  • Serbia
      • Belgrade, Serbia
        • Clinical for Pulmonary Diseases, Clinical Center of Serbia
      • Novi Sad, Serbia
        • Institute for Child and Youth Health Care of Vojvodina
      • Sremska Kamenica, Serbia
        • Institute for Pulmonary Disease of Vojvodina
  • Slovakia
      • Banská Bystrica, Slovakia
        • Children's faculty hospital with polyclinic Banska Bystrica
      • Košice, Slovakia
        • Children's Faculty Hospital Kosice
  • Spain
      • Barcelona, Spain
        • Unidad de Fibrosis Quistica Adultos
      • Barcelona, Spain
        • Unidad de Fibrosis Quistica Pediatria
      • Valencia, Spain
        • Unidad de Fibrosis Quistica y Transplante Pulmonar
  • Sweden
      • Lund, Sweden
        • Skåne University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United Kingdom
      • Birmingham, United Kingdom
        • Birmingham Women's and Children's NHS Foundation Trust
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, United Kingdom
        • Royal Papworth Hospital NHS Foundation Trust
      • Llandough, United Kingdom
        • Cardiff and Vale University Health Board
      • London, United Kingdom
        • Barts Health NHS Trust
      • London, United Kingdom
        • Royal Brompton & Harefield NHS Foundation Trust
      • Nottingham, United Kingdom
        • Wolfson Cystic Fibrosis Centre City Hospital Campus
      • Southampton, United Kingdom
        • University Hospital Southampton NHS Foundation Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom
        • Liverpool Heart and Chest Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom
        • Belfast City Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Long Beach, California, United States, 90806
        • Miller Children's Hospital
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, PA
      • Tampa, Florida, United States, 33606
        • USF Center for Advance Lung Disease
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Glenview, Illinois, United States, 60025
        • The Cystic Fibrosis Institute
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center (main location)
      • Manchester, New Hampshire, United States, 03104
        • Dartmouth-Hitchcock Manchester (satellite site)
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health Children's Hospital
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School
    • New York
      • Hawthorne, New York, United States, 10532
        • New York Medical College
      • New Hyde Park, New York, United States, 11040
        • North Shore Lij Health System
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center / Penn State College of Medicine
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Children's Specialty Clinic
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Tyler, Texas, United States, 75708
        • The University of Texas Health Science Center at Tyler
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital and UW Health Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo BID
Other: Placebo
Subjects will receive placebo twice daily.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
Time Frame: 28 weeks (Baseline Day 0 to Week 28)
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.
28 weeks (Baseline Day 0 to Week 28)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary Exacerbation (PEx) Rate
Time Frame: 28 weeks (Baseline Day 0 to Week 28)
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
28 weeks (Baseline Day 0 to Week 28)
Time to First New Pulmonary Exacerbation (PEx)
Time Frame: 28 weeks (Baseline Day 0 to Week 28)
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
28 weeks (Baseline Day 0 to Week 28)
Pulmonary Exacerbation (PEx)
Time Frame: 28 weeks (Baseline Day 0 to Week 28)
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.
28 weeks (Baseline Day 0 to Week 28)
CFQ-R Respiratory Symptom Domain
Time Frame: 28 weeks (Change from Baseline Day 0 to Week 28)
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.
28 weeks (Change from Baseline Day 0 to Week 28)
FEV1 % Predicted
Time Frame: 28 weeks (Change from Baseline Day 0 to Week 28)
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.
28 weeks (Change from Baseline Day 0 to Week 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corbus Pharmaceuticals Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cystic Fibrosis Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Chmiel, MD, Indiana University School of Medicine/Riley Physicians Pulmonary
  • Principal Investigator: J. Stuart Elborn, MD, National Heart and Lung Institute, Imperial College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JBT101-CF-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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