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

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ClinicalTrials.gov Identifier: NCT02465450
Recruitment Status : Completed
First Posted : June 8, 2015
Results First Posted : February 9, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: JBT-101 (lenabasum) Other: Placebo Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2015
Actual Primary Completion Date : December 28, 2016
Actual Study Completion Date : December 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events. [ Time Frame: 84 days of treatment ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02465450


  Show 27 Study Locations
Sponsors and Collaborators
Corbus Pharmaceuticals Inc.
Investigators
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

Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02465450     History of Changes
Other Study ID Numbers: JBT101-CF-001
First Posted: June 8, 2015    Key Record Dates
Results First Posted: February 9, 2018
Last Update Posted: April 4, 2018
Last Verified: March 2018

Keywords provided by Corbus Pharmaceuticals Inc.:
JBT-101, Lenabasum, Cystic Fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases