Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis

March 8, 2018 updated by: Corbus Pharmaceuticals Inc.

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).

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.

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 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.
85

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

  • Belgium
      • Brussels, Belgium
        • Hopital Erasme
  • France
      • Montpellier, France
        • Hopital Arnaud de Villeneuve
      • Nice, France
        • Institution Hôpital Pasteur
      • Roscoff, France
        • Centre de Perharidy
  • Germany
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • Christiane Herzog CF-Zentrum Frankfurt am Main
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45127
        • UNI Essen Abt.Pneumologie
  • Italy
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
      • Verona, Italy
        • AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica
  • Poland
      • Gdańsk, Poland, 80-308
        • Szpital Dziecięcy Polanki im. Macieja Płażyńskiego w Gdańsku Spółka z o.o. Poradnia Leczenia Mukowiscydozy
      • Rabka Zdrój, Poland, 34-700
        • Sanatorium Cassia-Villa Medica s.c
      • Rzeszów, Poland, 35-612
        • Podkarpacki Ośrodek Pulmunologii i Alergologii
      • Warszawa, Poland, 01-138
        • Instytut Gruźlicy i Chorób Płuc I Klinika Chorób Płuc
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast City Hospital
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • University of Arkansas for Medical Sciences
    • California
      • Long Beach, California, United States
        • Long Beach Memorial Medical Center/Miller Children's and Women's Hospital
    • Colorado
      • Denver, Colorado, United States
        • National Jewish Health
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Children's Hospital
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Robert-Wood Johnson Medical School
    • New York
      • New Hyde Park, New York, United States
        • North Shore Lij Health System
      • Valhalla, New York, United States
        • New York Medical College
    • Ohio
      • Cleveland, Ohio, United States
        • University Hospitals Cleveland Medical Center
    • South Carolina
      • Charleston, South Carolina, United States
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States
        • The University of Texas Southwestern Medical Center
      • Houston, Texas, United States
        • Texas Children's Hospital Clinical Care Center

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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:

    1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test;
    2. Two well-characterized mutations in the CFTR gene
  • FEV1 ≥ 40% predicted corrected
  • Stable treatment of CF for 14 days before Visit 1

Exclusion Criteria:

  • Severe or unstable CF, such as:

    1. Intravenous antibiotic treatment within 14 days before Visit 1
    2. 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:

    1. A positive pregnancy test (or at Visit 1);
    2. Hemoglobin < 10 g/dL
    3. Neutrophils < 1.0 x 10~9/L
    4. Platelets < 75 x 10~9/L
    5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation
    6. Serum transaminases > 2.5 x upper normal limit
    7. 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.

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: Sequential 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.
Experimental: JBT101 (lenabasum) 1 mg
JBT-101 1 mg once a day on Days 1-28
Drug: 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.
Experimental: JBT-101 (lenabasum) 5 mg
JBT-101 5 mg once a day on Days 1-28
Drug: 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.
Placebo Comparator: Placebo
Placebo once a day on Days 1-28.
Other: Placebo
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.
Experimental: JBT-101 (lenabasum) 20 mg QD
JBT-101 20 mg once a day on Days 29-84.
Drug: 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.
Experimental: JBT-101 (lenabasum) 20 mg BID
JBT-101 20 mg twice daily on Days 29-84.
Drug: 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.
Placebo Comparator: Placebo BID
Placebo twice daily on Days 29-84.
Other: Placebo
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.

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
Time Frame
Number of Participants With Treatment Emergent Adverse Events.
Time Frame: 84 days of treatment
84 days of treatment

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
JBT-101 (Lenabasum) Plasma Concentrations on Day 84
Time Frame: Day 84
Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84.
Day 84

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.

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, M.D., University Hospitals Cleveland Medical Center, Cleveland, OH
  • Principal Investigator: J S Elborn, M.D., Queens University, Belfast, Northern Ireland, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 29, 2015

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.
December 28, 2016

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.
December 28, 2016

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).
June 4, 2015

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.
June 4, 2015

First Posted (Estimate)

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.
June 8, 2015

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.
April 4, 2018

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.
March 8, 2018

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.
March 1, 2018

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-001

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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