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Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

NCT03451045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2023-01-18

Study results available
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Summary

This is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks.

Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.

Conditions

Interventions

DRUG

Lenabasum 20 mg

Subjects will receive lenabasum 20 mg twice daily.

DRUG

Lenabasum 5 mg

Subjects will receive lenabasum 5 mg twice daily.

OTHER

Placebo

Subjects will receive placebo twice daily.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Corbus Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • James Chmiel, MD · Indiana University School of Medicine/Riley Physicians Pulmonary

  • J. Stuart Elborn, MD · National Heart and Lung Institute, Imperial College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2020-06-17
Completion
2020-06-17
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

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 NCT03451045 on ClinicalTrials.gov