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

NCT02465450 | Completed Phase 2 Results DMC

• 1 other identifier: JBT101-CF-001
• Study Type: interventional
• Target: 85
• Locations: 7 countries
• Sites: 27

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).

Conditions

Cystic Fibrosis

Keywords

JBT-101, Lenabasum, Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events.

  84 days of treatment

Secondary Outcomes (1)

• JBT-101 (Lenabasum) Plasma Concentrations on Day 84

  Day 84

Study Arms (6)

JBT101 (lenabasum) 1 mg

EXPERIMENTAL

JBT-101 1 mg once a day on Days 1-28

Drug: JBT-101 (lenabasum)

JBT-101 (lenabasum) 5 mg

EXPERIMENTAL

JBT-101 5 mg once a day on Days 1-28

Drug: JBT-101 (lenabasum)

Placebo

PLACEBO COMPARATOR

Placebo once a day on Days 1-28.

Other: Placebo

JBT-101 (lenabasum) 20 mg QD

EXPERIMENTAL

JBT-101 20 mg once a day on Days 29-84.

Drug: JBT-101 (lenabasum)

JBT-101 (lenabasum) 20 mg BID

EXPERIMENTAL

JBT-101 20 mg twice daily on Days 29-84.

Drug: JBT-101 (lenabasum)

Placebo BID

PLACEBO COMPARATOR

Placebo twice daily on Days 29-84.

Other: Placebo

Interventions

JBT-101 (lenabasum) DRUG

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.

JBT-101 (lenabasum) 20 mg BID; JBT-101 (lenabasum) 20 mg QD; JBT-101 (lenabasum) 5 mg; JBT101 (lenabasum) 1 mg

Placebo OTHER

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.

Placebo; Placebo BID

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Corbus Pharmaceuticals Inc.: lead

Study Sites (27)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Location

Long Beach Memorial Medical Center/Miller Children's and Women's Hospital

Long Beach, California, United States

Location

National Jewish Health

Denver, Colorado, United States

Location

Boston Children's Hospital

Boston, Massachusetts, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Rutgers Robert-Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

North Shore LIJ Health System

New Hyde Park, New York, United States

Location

New York Medical College

Valhalla, New York, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Location

Texas Children's Hospital Clinical Care Center

Houston, Texas, United States

Location

Hôpital Erasme

Brussels, Belgium

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Institution Hôpital Pasteur

Nice, France

Location

Centre de Perharidy

Roscoff, France

Location

Christiane Herzog CF-Zentrum Frankfurt am Main

Frankfurt am Main, Hesse, 60590, Germany

Location

UNI Essen Abt.Pneumologie

Essen, North Rhine-Westphalia, 45127, Germany

Location

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica

Verona, Italy

Location

Szpital Dziecięcy Polanki im. Macieja Płażyńskiego w Gdańsku Spółka z o.o. Poradnia Leczenia Mukowiscydozy

Gdansk, 80-308, Poland

Location

Sanatorium Cassia-Villa Medica s.c

Rabka-Zdrój, 34-700, Poland

Location

Podkarpacki Ośrodek Pulmunologii i Alergologii

Rzeszów, 35-612, Poland

Location

Instytut Gruźlicy i Chorób Płuc I Klinika Chorób Płuc

Warsaw, 01-138, Poland

Location

Belfast City Hospital

Belfast, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Related Publications (1)

• Chmiel JF, Flume P, Downey DG, Dozor AJ, Colombo C, Mazurek H, Sapiejka E, Rachel M, Constantine S, Conley B, Dgetluck N, Dinh Q, White B, Elborn JS; Lenabasum JBT101-CF-001 Study Group. Safety and efficacy of lenabasum in a phase 2 randomized, placebo-controlled trial in adults with cystic fibrosis. J Cyst Fibros. 2021 Jan;20(1):78-85. doi: 10.1016/j.jcf.2020.09.008. Epub 2020 Oct 1.

  PMID: 33011099 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

lenabasum

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Ajay Aggarwal, MD
• Organization: Corbus Pharmaceuticals

aaggarwal@corbuspharma.com

781-250-9176

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 8, 2015
• Study Start: September 29, 2015
• Primary Completion: December 28, 2016
• Study Completion: December 28, 2016
• Last Updated: April 4, 2018
• Results First Posted: February 9, 2018

Record last verified: 2018-03

Locations

FR (3); US (12); DE (2); IT (3); PL (4); GB (2); BE (1)