Cystic FibrosisPhase 2NCT02465450
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
A Phase 2 study testing JBT-101 (lenabasum) in people with Cystic Fibrosis, run by Corbus Pharmaceuticals Inc. at 27 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- JBT-101 (lenabasum)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 27 sitesin 7 countries
- Study dates
- 29 Sep 2015to 28 Dec 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
- Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test;
- Two well-characterized mutations in the CFTR gene
- FEV1 ≥ 40% predicted corrected
- Stable treatment of CF for 14 days before Visit 1
Who cannot join
- Severe or unstable CF, such as:
- Intravenous antibiotic treatment within 14 days before Visit 1
- Treatment with any corticosteroids > 10 mg per day or > 20 mg every other day oral prednisone or equivalent within 14 days before Visit 1
- Any one of the following values for laboratory tests at Screening:
- A positive pregnancy test (or at Visit 1);
- Hemoglobin < 10 g/dL
Show all 12Show fewer
- Neutrophils < 1.0 x 10~9/L
- Platelets < 75 x 10~9/L
- Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation
- Serum transaminases > 2.5 x upper normal limit
- Total bilirubin ≥ 1.5 x upper limit of normal
- Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Trial locations and contacts
27 sites in 7 countries.
27 sites in 7 countries
United States12 sites
Boston Children's Hospital
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
University Hospitals Cleveland Medical Center
Cleveland, Ohio
The University of Texas Southwestern Medical Center
Dallas, Texas
National Jewish Health
Denver, Colorado
Texas Children's Hospital Clinical Care Center
Houston, Texas
University of Arkansas for Medical Sciences
Little Rock, Arkansas
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital
Long Beach, California
Rutgers Robert-Wood Johnson Medical School
New Brunswick, New Jersey, 08903
North Shore LIJ Health System
New Hyde Park, New York
New York Medical College
Valhalla, New York
Poland4 sites
Szpital Dziecięcy Polanki im. Macieja Płażyńskiego w Gdańsku Spółka z o.o. Poradnia Leczenia Mukowiscydozy
Gdansk, 80-308
Sanatorium Cassia-Villa Medica s.c
Rabka-Zdrój, 34-700
Podkarpacki Ośrodek Pulmunologii i Alergologii
Rzeszów, 35-612
Instytut Gruźlicy i Chorób Płuc I Klinika Chorób Płuc
Warsaw, 01-138
France3 sites
Hôpital Arnaud de Villeneuve
Montpellier
Institution Hôpital Pasteur
Nice
Centre de Perharidy
Roscoff
Italy3 sites
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica
Verona
Germany2 sites
UNI Essen Abt.Pneumologie
Essen, North Rhine-Westphalia, 45127
Christiane Herzog CF-Zentrum Frankfurt am Main
Frankfurt am Main, Hesse, 60590
United Kingdom2 sites
Belfast City Hospital
Belfast
Queen Elizabeth University Hospital
Glasgow
About this study
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
Read the detailed description
An interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in 70 subjects ≥ 18 and < 65 years of age with documented cystic fibrosis. There will up a screening period of up to 28 days, 84 days treatment period, and 28 days follow-up.
- Conditions
- Cystic Fibrosis
- Being tested
- JBT-101 (lenabasum), Placebo
- Keywords
- JBT-101, Lenabasum, Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JBT-101 (lenabasum)Drug
Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.
PlaceboOther
Subjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
| Study group | Role | What they receive |
|---|---|---|
| JBT101 (lenabasum) 1 mg | Experimental | JBT-101 1 mg once a day on Days 1-28 Receives: Drug: JBT-101 (lenabasum) |
| JBT-101 (lenabasum) 5 mg | Experimental | JBT-101 5 mg once a day on Days 1-28 Receives: Drug: JBT-101 (lenabasum) |
| Placebo | Placebo comparator | Placebo once a day on Days 1-28. Receives: Other: Placebo |
| JBT-101 (lenabasum) 20 mg QD | Experimental | JBT-101 20 mg once a day on Days 29-84. Receives: Drug: JBT-101 (lenabasum) |
| JBT-101 (lenabasum) 20 mg BID | Experimental | JBT-101 20 mg twice daily on Days 29-84. Receives: Drug: JBT-101 (lenabasum) |
| Placebo BID | Placebo comparator | Placebo twice daily on Days 29-84. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events.
Measured: 84 days of treatment
Secondary outcomes (1)
JBT-101 (Lenabasum) Plasma Concentrations on Day 84
Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84.
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start29 Sep 2015
- Primary completion28 Dec 2016
- Study completion28 Dec 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corbus Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Chmiel, M.D., Principal investigator, University Hospitals Cleveland Medical Center, Cleveland, OHJ S Elborn, M.D., Principal investigator, Queens University, Belfast, Northern Ireland, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465450
- Sponsor's protocol ID
- JBT101-CF-001
- Status last verified
- Mar 2018
- First submitted
- 4 Jun 2015
- Last updated
- 4 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chmiel JF, Flume P, Downey DG, Dozor AJ, Colombo C, Mazurek H, Sapiejka E, Rachel M, Constantine S, Conley B, Dgetluck N, Dinh Q, White B, Elborn JS; Lenabasum JBT101-CF-001 Study Group. Safety and efficacy of lenabasum in a phase 2 randomized, placebo-controlled trial in adults with cystic fibrosis. J Cyst Fibros. 2021 Jan;20(1):78-85. doi: 10.1016/j.jcf.2020.09.008. Epub 2020 Oct 1.
PubMed 33011099
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02465450
- Acronym / sponsor ID
- JBT101-CF-001
- Conditions
- Cystic Fibrosis
- Keywords
- JBT-101, Lenabasum, Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Corbus Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- 28 Dec 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 9 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
Detailed description
An interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in 70 subjects ≥ 18 and < 65 years of age with documented cystic fibrosis. There will up a screening period of up to 28 days, 84 days treatment period, and 28 days follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| JBT101 (lenabasum) 1 mg | Experimental | Drug: JBT-101 (lenabasum)JBT-101 1 mg once a day on Days 1-28 |
| JBT-101 (lenabasum) 5 mg | Experimental | Drug: JBT-101 (lenabasum)JBT-101 5 mg once a day on Days 1-28 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo once a day on Days 1-28. |
| JBT-101 (lenabasum) 20 mg QD | Experimental | Drug: JBT-101 (lenabasum)JBT-101 20 mg once a day on Days 29-84. |
| JBT-101 (lenabasum) 20 mg BID | Experimental | Drug: JBT-101 (lenabasum)JBT-101 20 mg twice daily on Days 29-84. |
| Placebo BID | Placebo comparator | Other: PlaceboPlacebo twice daily on Days 29-84. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
- FEV1 ≥ 40% predicted corrected
- Stable treatment of CF for 14 days before Visit 1
Key exclusion criteria (12 listed)
- Severe or unstable CF, such as:
- Any one of the following values for laboratory tests at Screening:
- Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, 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 |
|---|---|---|
| JBT-101 (lenabasum)Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84. | Drug | JBT-101 (lenabasum) 20 mg BID, JBT-101 (lenabasum) 20 mg QD, JBT-101 (lenabasum) 5 mg, JBT101 (lenabasum) 1 mg |
| PlaceboSubjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84. | Other | Placebo, Placebo BID |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events.
Time frame: 84 days of treatment
1 secondary outcome
JBT-101 (Lenabasum) Plasma Concentrations on Day 84
Time frame: Day 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33011099Chmiel JF, Flume P, Downey DG, Dozor AJ, Colombo C, Mazurek H, Sapiejka E, Rachel M, Constantine S, Conley B, Dgetluck N, Dinh Q, White B, Elborn JS; Lenabasum JBT101-CF-001 Study Group. Safety and efficacy of lenabasum in a phase 2 randomized, placebo-controlled trial in adults with cystic fibrosis. J Cyst Fibros. 2021 Jan;20(1):78-85. doi: 10.1016/j.jcf.2020.09.008. Epub 2020 Oct 1.
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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, M.D. principal investigator
University Hospitals Cleveland Medical Center, Cleveland, OH
J S Elborn, M.D. principal investigator
Queens University, Belfast, Northern Ireland, United Kingdom
27 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JBT-101 (lenabasum) in people with Cystic Fibrosis, run by Corbus Pharmaceuticals Inc. at 27 sites in 7 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 5 inclusion and 12 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Poland, France, Italy, Germany and 2 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 9 Feb 2018). 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?
Number of Participants With Treatment Emergent Adverse Events. (time frame: 84 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02465450, which also lists 1 linked publication.
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 4 Apr 2018.