Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis
- Registration Number
- NCT02465450
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
-
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
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JBT101 (lenabasum) 1 mg JBT-101 (lenabasum) JBT-101 1 mg once a day on Days 1-28 JBT-101 (lenabasum) 5 mg JBT-101 (lenabasum) JBT-101 5 mg once a day on Days 1-28 JBT-101 (lenabasum) 20 mg QD JBT-101 (lenabasum) JBT-101 20 mg once a day on Days 29-84. Placebo Placebo Placebo once a day on Days 1-28. JBT-101 (lenabasum) 20 mg BID JBT-101 (lenabasum) JBT-101 20 mg twice daily on Days 29-84. Placebo BID Placebo Placebo twice daily on Days 29-84.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events. 84 days of treatment
- Secondary Outcome Measures
Name Time Method JBT-101 (Lenabasum) Plasma Concentrations on Day 84 Day 84 Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84.
Trial Locations
- Locations (27)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Long Beach Memorial Medical Center/Miller Children's and Women's Hospital
🇺🇸Long Beach, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Rutgers Robert-Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
North Shore LIJ Health System
🇺🇸New Hyde Park, New York, United States
New York Medical College
🇺🇸Valhalla, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Scroll for more (17 remaining)University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States