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

NCT02465450 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2018-04-04

Study results available
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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

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.

Sponsors & Collaborators

  • Corbus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • James Chmiel, M.D. · University Hospitals Cleveland Medical Center, Cleveland, OH

  • J S Elborn, M.D. · Queens University, Belfast, Northern Ireland, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-29
Primary Completion
2016-12-28
Completion
2016-12-28

Countries

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

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465450 on ClinicalTrials.gov