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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).

Key facts

Study ID

NCT02465450

Run by

Corbus Pharmaceuticals Inc.

People needed

85

Starts

2015-09-29

Expected to finish

2016-12-28

Last updated by the study team

2018-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• The University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Texas Children's Hospital Clinical Care Center — Houston, Texas, United States
• Hôpital Erasme — Brussels, Belgium
• Hôpital Arnaud de Villeneuve — Montpellier, France
• Institution Hôpital Pasteur — Nice, France
• Centre de Perharidy — Roscoff, France
• Christiane Herzog CF-Zentrum Frankfurt am Main — Frankfurt am Main, Hesse, Germany
• UNI Essen Abt.Pneumologie — Essen, North Rhine-Westphalia, Germany
• Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico — Milan, Italy
• Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Italy
• AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica — Verona, Italy
• Szpital Dziecięcy Polanki im. Macieja Płażyńskiego w Gdańsku Spółka z o.o. Poradnia Leczenia Mukowiscydozy — Gdansk, Poland
• Sanatorium Cassia-Villa Medica s.c — Rabka-Zdrój, Poland
• Podkarpacki Ośrodek Pulmunologii i Alergologii — Rzeszów, Poland
• Instytut Gruźlicy i Chorób Płuc I Klinika Chorób Płuc — Warsaw, Poland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.