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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465450
• Other study ID #: JBT101-CF-001
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2015
• Last updated: March 8, 2018
• Start date: September 29, 2015
• Est. completion date: December 28, 2016

Study information

• Verified date: March 2018
• Source: Corbus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 28, 2016
• Est. primary completion date: December 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

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.

Locations

Country	Name	City	State
Belgium	Hôpital Erasme	Brussels
France	Hôpital Arnaud de Villeneuve	Montpellier
France	Institution Hôpital Pasteur	Nice
France	Centre de Perharidy	Roscoff
Germany	UNI Essen Abt.Pneumologie	Essen	North Rhine-Westphalia
Germany	Christiane Herzog CF-Zentrum Frankfurt am Main	Frankfurt am Main	Hesse
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano
Italy	AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica	Verona
Poland	Szpital Dzieciecy Polanki im. Macieja Plazynskiego w Gdansku Spólka z o.o. Poradnia Leczenia Mukowiscydozy	Gdansk
Poland	Sanatorium Cassia-Villa Medica s.c	Rabka Zdrój
Poland	Podkarpacki Osrodek Pulmunologii i Alergologii	Rzeszów
Poland	Instytut Gruzlicy i Chorób Pluc I Klinika Chorób Pluc	Warszawa
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Queen Elizabeth University Hospital	Glasgow
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	Texas Children's Hospital Clinical Care Center	Houston	Texas
United States	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Corbus Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events.		84 days of treatment
Secondary	JBT-101 (Lenabasum) Plasma Concentrations on Day 84	Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84.	Day 84