Cystic FibrosisPhase 2NCT03451045
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
A Phase 2 study testing Lenabasum 20 mg and Lenabasum 5 mg in people with Cystic Fibrosis, run by Corbus Pharmaceuticals Inc. at 105 sites in 21 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Lenabasum 20 mg and Lenabasum 5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 447 participants
- Where
- 105 sitesin 21 countries
- Study dates
- 22 Dec 2017to 17 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
105 sites in 21 countries.
105 sites in 21 countries
United States34 sites
Emory Children's Center
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center
Dallas, Texas, 75390
National Jewish Health
Denver, Colorado, 80206
Cook Children's Medical Center
Fort Worth, Texas, 76104
The Cystic Fibrosis Institute
Glenview, Illinois, 60025
New York Medical College
Hawthorne, New York, 10532
Milton S. Hershey Medical Center / Penn State College of Medicine
Hershey, Pennsylvania, 17033
Texas Children's Hospital
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center (main location)
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Miller Children's Hospital
Long Beach, California, 90806
University Hospital and UW Health Clinics
Madison, Wisconsin, 53792
Dartmouth-Hitchcock Manchester (satellite site)
Manchester, New Hampshire, 03104
University of Miami
Miami, Florida, 33136
Atlantic Health Children's Hospital
Morristown, New Jersey, 07960
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
North Shore LIJ Health System
New Hyde Park, New York, 11040
Mount Sinai Beth Israel
New York, New York, 10003
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah
Salt Lake City, Utah, 84132
Sanford Children's Specialty Clinic
Sioux Falls, South Dakota, 57105
USF Center for Advance Lung Disease
Tampa, Florida, 33606
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708
France10 sites
Centre de Référence de la Mucoviscidose
Bron
Service de Pneumologie, Allergologie, Mucoviscidose; Hôpital Femme-Mère-Enfant
Bron
Service de Pediatrie Medico-Chirurgicale et Genetique
Dijon
CHRU de Montpellier
Montpellier
CRCM Enfant de Nancy
Nancy
CHU de Nice
Nice
Centre de Recherche en Explorations Fonctionnelles (CREF)
Paris
CRCM Hôpital Necker
Paris
Foundation ILDYS
Roscoff
Nouvel Hopital Civil Strasbourg
Strasbourg
United Kingdom10 sites
Belfast City Hospital
Belfast, Northern Ireland
Birmingham Women's and Children's NHS Foundation Trust
Birmingham
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Royal Papworth Hospital NHS Foundation Trust
Cambridge
Liverpool Heart and Chest Hospital
Liverpool, Merseyside
Cardiff and Vale University Health Board
Llandough
Barts Health NHS Trust
London
Royal Brompton & Harefield NHS Foundation Trust
London
Wolfson Cystic Fibrosis Centre City Hospital Campus
Nottingham
University Hospital Southampton NHS Foundation Trust
Southampton
Germany8 sites
Charité Universitätsmedzin
Berlin
Catholic Hospital Bochum - St. Josef-Hospital
Bochum
University Hospital Essen
Essen
University Medicine Essen Ruhrlandklinik
Essen
Goethe University Children´s Hospital
Frankfurt
Hannover Medical School
Hanover
University Hospital Jena
Jena
Klinikum der Ludwig Maximilian Universität München
München
Hungary5 sites
National Koranyi Institute of Pulmonology, Department of Cystic Fibrosis
Budapest
University of Debrecen - Kenezy Gyula University Hospital
Debrecen
Bács-Kiskun County Hospital, Teaching Hospital of the University of Szeged
Kecskemét
Moritz Kaposi General Hospital, Mosdós, Department of Pediatric Pulmonary Rehabilitation
Mosdós
Pediatric Pulmonology, Törökbálint, Hungary
Törökbálint
Italy5 sites
Centro Regionale Toscano di Riferimento per la Fibrosi Cistica
Florence
U.O.S.D. - Centro fibrosi cistica
Genova
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera Universitaria Verona
Verona
Canada4 sites
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
St. Michael's Hospital
Toronto
The Hospital for Sick Children
Toronto
St. Paul's Hospital
Vancouver
Poland4 sites
Instytut Matki I Dziecka, Centrum Leczenia Mukowiscydozy - Oddzial Chorob Pluc
Dziekanów Leśny, 05-092
Oddzial Pediatrii z Pododdzialem Leczenia Mukowiscydozy
Gdansk
Instytut Gruzlicy I Chorob Pluc Oddzial Terenowy im Jana I Ireny Rudnikow
Rabka-Zdrój, 34-700
Institute for Mother and Child, Department of CF for Children's and Youth
Rzeszów
Russia4 sites
Scientfic Research Institute of Pulmonology
Moscow
Diagnostic Children Hospital, Department of Pediatrics and Adolescent Medicine, Department of Pediatric Pulmonary, Allergology and Endocrinology
Mytishchi
Children's City Hospital of Saint Olga
Saint Petersburg
First St. Petersburg State Pavlov Medical University
Saint Petersburg
Bulgaria3 sites
Medical Center Prolet EOOD
Rousse
UMHAT Alexandrovska
Sofia
MHAT Sveta Marina EAD
Varna
Serbia3 sites
Clinical for Pulmonary Diseases, Clinical Center of Serbia
Belgrade
Institute for Pulmonary Disease of Vojvodina
Kamenitz
Institute for Child and Youth Health Care of Vojvodina
Novi Sad
Spain3 sites
Unidad de Fibrosis Quistica Adultos
Barcelona
Unidad de Fibrosis Quistica Pediatria
Barcelona
Unidad de Fibrosis Quistica y Transplante Pulmonar
Valencia
Austria2 sites
Cystic Fibrosis Centre Innsbruck Medical University of Innsbruck, Dept. for Child and Adolescent Health, University Clinic for Paediatrics, Cardiology, Pneumology, Allergology, Cystic Fibrosis
Innsbruck
Medical University of Vienna
Vienna
Slovakia2 sites
Children's faculty hospital with polyclinic Banska Bystrica
Banská Bystrica
Children's Faculty Hospital Kosice
Košice
Sweden2 sites
Skane University Hospital
Lund
Karolinska University Hospital
Stockholm
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Lenabasum 20 mg, Lenabasum 5 mg, Placebo
- Keywords
- Pulmonary exacerbation, lenabasum, JBT-101
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenabasum 20 mgDrug
Subjects will receive lenabasum 20 mg twice daily.
Lenabasum 5 mgDrug
Subjects will receive lenabasum 5 mg twice daily.
PlaceboOther
Subjects will receive placebo twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Lenabasum 20 mg BID | Experimental | Not described Receives: Drug: Lenabasum 20 mg |
| Lenabasum 5 mg BID | Experimental | Not described Receives: Drug: Lenabasum 5 mg |
| Placebo BID | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 weeks (Baseline Day 0 to Week 28)
Secondary outcomes (5)
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
Measured: 28 weeks (Baseline Day 0 to Week 28)
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
Measured: 28 weeks (Baseline Day 0 to Week 28)
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.
Measured: 28 weeks (Baseline Day 0 to Week 28)
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.
Measured: 28 weeks (Change from Baseline Day 0 to Week 28)
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.
Measured: 28 weeks (Change from Baseline Day 0 to Week 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start22 Dec 2017
- Primary completion17 Jun 2020
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- James Chmiel, MD, Principal investigator, Indiana University School of Medicine/Riley Physicians PulmonaryJ. Stuart Elborn, MD, Principal investigator, National Heart and Lung Institute, Imperial College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451045
- Sponsor's protocol ID
- JBT101-CF-002
- Status last verified
- Dec 2022
- First submitted
- 23 Feb 2018
- Last updated
- 18 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03451045
- Acronym / sponsor ID
- JBT101-CF-002
- Conditions
- Cystic Fibrosis
- Keywords
- Pulmonary exacerbation, lenabasum, JBT-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Posted 18 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Multicenter, double-blind, randomized, placebo-controlled, parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Lenabasum 20 mg BID | Experimental | Drug: Lenabasum 20 mg |
| Lenabasum 5 mg BID | Experimental | Drug: Lenabasum 5 mg |
| Placebo BID | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (9 listed)
- Severe or unstable CF at screening or Visit 1.
- Any of the following values for laboratory tests at screening:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenabasum 20 mgSubjects will receive lenabasum 20 mg twice daily. | Drug | Lenabasum 20 mg BID |
| Lenabasum 5 mgSubjects will receive lenabasum 5 mg twice daily. | Drug | Lenabasum 5 mg BID |
| PlaceboSubjects will receive placebo twice daily. | Other | Placebo BID |
Primary outcome
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.
5 secondary outcomes
Pulmonary Exacerbation (PEx) Rate
Time frame: 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)
Pulmonary Exacerbation (PEx)
Time frame: 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)
FEV1 % Predicted
Time frame: 28 weeks (Change from Baseline Day 0 to Week 28)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Chmiel, MD principal investigator
Indiana University School of Medicine/Riley Physicians Pulmonary
J. Stuart Elborn, MD principal investigator
National Heart and Lung Institute, Imperial College
105 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lenabasum 20 mg and Lenabasum 5 mg in people with Cystic Fibrosis, run by Corbus Pharmaceuticals Inc. at 105 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States, France, United Kingdom, Germany, Hungary and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Exacerbation (PEx) Rate Over 28 Weeks (time frame: 28 weeks (Baseline Day 0 to Week 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.