Trials Sponsors Conditions Drugs Pricing

Conditions

Cystic Fibrosis

Keywords

Pulmonary exacerbation, lenabasum, JBT-101

Outcome Measures

Primary Outcomes (1)

Pulmonary Exacerbation (PEx) Rate Over 28 Weeks
Rate of PEx using the primary PEx definition with lenabasum 20 mg BID compared to placebo, during the treatment period. An primary PEx is defined on the physician's decision to treat with oral, intraveneous or inhaled antibiotics in the presence 4/12 Fuch's criteria (Change in sputum, new/increased hemoptysis, increased cough, increased dyspnea, malaise, fatigue/lethargy, Temperature greater than 38C, weight loss, sinus pain, change in sinus discharge, change in exam of chest, decrease in FEV1 of more than 10%, radiographic change). This excludes prophylactic antibiotics. A new PEx is a one that occurs at 28 days after the previous PEx.
28 weeks (Baseline Day 0 to Week 28)

Secondary Outcomes (5)

Pulmonary Exacerbation (PEx) Rate
28 weeks (Baseline Day 0 to Week 28)
Time to First New Pulmonary Exacerbation (PEx)
28 weeks (Baseline Day 0 to Week 28)
Pulmonary Exacerbation (PEx)
28 weeks (Baseline Day 0 to Week 28)
CFQ-R Respiratory Symptom Domain
28 weeks (Change from Baseline Day 0 to Week 28)
FEV1 % Predicted
28 weeks (Change from Baseline Day 0 to Week 28)

Study Arms (3)

Lenabasum 20 mg BID

EXPERIMENTAL

Drug: Lenabasum 20 mg

Lenabasum 5 mg BID

EXPERIMENTAL

Drug: Lenabasum 5 mg

Placebo BID

PLACEBO COMPARATOR

Other: Placebo

Interventions

Lenabasum 20 mgDrug

Subjects will receive lenabasum 20 mg twice daily.

Lenabasum 20 mg BID

Lenabasum 5 mgDrug

Subjects will receive lenabasum 5 mg twice daily.

Lenabasum 5 mg BID

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

≥ 12 years of age at the time Informed Consent/ Assent is signed.
Weight ≥ 40 kg.

Sponsors & Collaborators

Corbus Pharmaceuticals Inc.
Industrylead
Cystic Fibrosis Foundation
Othercollaborator

Study Sites (105)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Miller Children's Hospital

Long Beach, California, 90806, United States

National Jewish Health

Denver, Colorado, 80206, United States

University of Miami

Miami, Florida, 33136, United States

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803, United States

USF Center for Advance Lung Disease

Tampa, Florida, 33606, United States

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

lenabasum

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Results Point of Contact

Title: Head of Clinical Operations
Organization: Corbus Pharmaceuticals, Inc.

Study Officials

James Chmiel, MD
Indiana University School of Medicine/Riley Physicians Pulmonary
PRINCIPAL INVESTIGATOR
J. Stuart Elborn, MD
National Heart and Lung Institute, Imperial College
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

447 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

December 22, 2017

Actual (reported)

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Lenabasum 20 mg BID

Lenabasum 5 mg BID

Placebo BID

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (105)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Lenabasum 20 mg BID

Lenabasum 5 mg BID

Placebo BID

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (105)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations