Status:
COMPLETED
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Lead Sponsor:
Corbus Pharmaceuticals Inc.
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 old...
Eligibility Criteria
Inclusion
- ≥ 12 years of age at the time Informed Consent/ Assent is signed.
- Weight ≥ 40 kg.
- FEV1 ≥ 40% predicted and \< 100% predicted in the last 12 months.
- Physician-initiated treatment with an IV antibiotic 2 or 3 times in the last 12 months for a new PEx or physician-initiated treatment with an IV antibiotic 1 time in the last 12 months plus physician-initiated treatment with oral antibiotic(s) 1 or more times in the past 12 months for a new PEX.
Exclusion
- Severe or unstable CF at screening or Visit 1.
- Any of the following values for laboratory tests at screening:
- A positive pregnancy test.
- Hemoglobin \< 10 g/dL in males and \< 9 g/dL in females.
- Neutrophils \< 1.0 x 10\^9 /L.
- Platelets \< 75 x 10\^9/L.
- Creatinine clearance \< 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
- Serum transaminases \> 2.5 x upper limit of normal.
- Any medical condition or concurrent medical therapies at screening or Visit 1 that may put the subject at greater safety risk, influence response to study drug or interfere with study assessments.
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2020
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT03451045
Start Date
December 22 2017
End Date
June 17 2020
Last Update
January 18 2023
Active Locations (105)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Miller Children's Hospital
Long Beach, California, United States, 90806
4
National Jewish Health
Denver, Colorado, United States, 80206