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

PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

September 29, 2015

Primary Completion Date

December 28, 2016

Study Completion Date

December 28, 2016

Conditions
Cystic Fibrosis
Interventions
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.

Trial Locations (27)

20122

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milan

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

45127

UNI Essen Abt.Pneumologie, Essen

60590

Christiane Herzog CF-Zentrum Frankfurt am Main, Frankfurt am Main

Unknown

University of Arkansas for Medical Sciences, Little Rock

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

National Jewish Health, Denver

Boston Children's Hospital, Boston

Massachusetts General Hospital, Boston

North Shore LIJ Health System, New Hyde Park

New York Medical College, Valhalla

University Hospitals Cleveland Medical Center, Cleveland

Medical University of South Carolina, Charleston

The University of Texas Southwestern Medical Center, Dallas

Texas Children's Hospital Clinical Care Center, Houston

Hôpital Erasme, Brussels

Hôpital Arnaud de Villeneuve, Montpellier

Institution Hôpital Pasteur, Nice

Centre de Perharidy, Roscoff

AOUI di Verona - Ospedale Borgo Trento UOC Fibrosi Cistica, Verona

Belfast City Hospital, Belfast

Queen Elizabeth University Hospital, Glasgow

08903

Rutgers Robert-Wood Johnson Medical School, New Brunswick

80-308

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

34-700

Sanatorium Cassia-Villa Medica s.c, Rabka-Zdrój

35-612

Podkarpacki Ośrodek Pulmunologii i Alergologii, Rzeszów

01-138

Instytut Gruźlicy i Chorób Płuc I Klinika Chorób Płuc, Warsaw

Sponsors
All Listed Sponsors
lead

Corbus Pharmaceuticals Inc.

INDUSTRY

NCT02465450 - Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis | Biotech Hunter | Biotech Hunter