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Trial record 1 of 1 for:    NCT02465450
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Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02465450
First Posted: June 8, 2015
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corbus Pharmaceuticals Inc.
  Purpose
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 Intervention Phase
Cystic Fibrosis Drug: JBT-101 Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by Corbus Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Number of participants with treatment emergent adverse events from baseline at Day 113 [ Time Frame: 112 days, with 84 days treatment and 28 days follow-up ]

Secondary Outcome Measures:
  • Change in JBT-101 plasma concentrations from baseline at Day 85 [ Time Frame: 84 days treatment period ]
  • Change in lung function from baseline at Day 85 [ Time Frame: 84 days treatment period ]
    Forced expiratory volume in one second (FEV1) and lung clearance index

  • Change in patient reported outcomes from baseline at Day 85 [ Time Frame: 84 days treatment period ]
    Cystic Fibrosis Questionnaire Revised - Respiratory Symptoms

  • Change in metabolipidomic profile from baseline at Day 85 [ Time Frame: 84 days treatment period ]
  • Change in blood biomarkers of disease activity from baseline to Day 85 [ Time Frame: 84 days treatment period ]
  • Change in sputum biomarkers of disease activity from baseline to Day 85 [ Time Frame: 84 days treatment period ]
  • Change in blood biomarkers of inflammation from baseline to Day 85 [ Time Frame: 84 days treatment period ]
  • Change in sputum microbiota from baseline to Day 85 [ Time Frame: 84 days treatment period ]
    Total bacterial load, bacterial genera, and relative abundance of each genera in sputum


Enrollment: 70
Actual Study Start Date: September 29, 2015
Study Completion Date: December 28, 2016
Primary Completion Date: December 28, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JBT101 1 mg/20 mg
JBT-101 1 mg once a day on Days 1-28, then JBT-101 20 mg every morning on Days 29-84 and placebo every evening on Days 29-84
Drug: JBT-101
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.
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 1 mg/20 mg bid
JBT-101 1 mg once a day on Days 1-28, then JBT-101 20 mg twice a day on Days 29-84
Drug: JBT-101
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 5 mg/20 mg
JBT-101 5 mg once a day on Days 1-28, then JBT-101 20 mg every morning on Days 29-84 and placebo every evening on Days 29-84
Drug: JBT-101
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.
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 5 mg/20 mg bid
JBT-101 5 mg once a day on Days 1-28, then JBT-101 20 mg twice a day on Days 29-84
Drug: JBT-101
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 0 mg/20 mg
Placebo once a day on Days 1-28, then JBT-101 20 mg every morning on Days 29-84 and placebo every evening on Days 29-84
Drug: JBT-101
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.
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 0 mg/20 mg bid
Placebo once a day on Days 1-28, then JBT-101 20 mg twice a day on Days 29-84
Drug: JBT-101
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, then placebo twice a day 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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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
  More Information

Responsible Party: Corbus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02465450     History of Changes
Other Study ID Numbers: JBT101-CF-001
First Submitted: June 4, 2015
First Posted: June 8, 2015
Last Update Posted: September 8, 2017
Last Verified: September 2017

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