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

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: JBT-101 (lenabasum); Other: Placebo

• 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.

Study Timeline

• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Study Start: 2015-09-29
• Primary Completion: 2016-12-28
• Study Completion: 2016-12-28
• Results First Submitted: 2018-01-11
• Results First Submitted QC: 2018-01-11
• Results First Posted: 2018-02-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

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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.

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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)

New York Medical College; 🇺🇸 Valhalla, New York, United States

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

Instytut Gruźlicy i Chorób Płuc I Klinika Chorób Płuc; 🇵🇱 Warszawa, Poland

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Szpital Dziecięcy Polanki im. Macieja Płażyńskiego w Gdańsku Spółka z o.o. Poradnia Leczenia Mukowiscydozy; 🇵🇱 Gdańsk, Poland

Sanatorium Cassia-Villa Medica s.c; 🇵🇱 Rabka Zdrój, Poland

Hôpital Erasme; 🇧🇪 Brussels, Belgium

Christiane Herzog CF-Zentrum Frankfurt am Main; 🇩🇪 Frankfurt am Main, Hesse, Germany

UNI Essen Abt.Pneumologie; 🇩🇪 Essen, North Rhine-Westphalia, Germany

The University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Rutgers Robert-Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Institution Hôpital Pasteur; 🇫🇷 Nice, France

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica; 🇮🇹 Verona, Italy

Podkarpacki Ośrodek Pulmunologii i Alergologii; 🇵🇱 Rzeszów, Poland

Texas Children's Hospital Clinical Care Center; 🇺🇸 Houston, Texas, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Long Beach Memorial Medical Center/Miller Children's and Women's Hospital; 🇺🇸 Long Beach, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

North Shore LIJ Health System; 🇺🇸 New Hyde Park, New York, United States

Centre de Perharidy; 🇫🇷 Roscoff, France