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
Cystic Fibrosis
Recruitment Status
COMPLETED
Eligibility Criteria
Inclusion Criteria:
1. ≥ 12 years of age at the time Informed Consent/ Assent is signed.
2. Weight ≥ 40 kg.
3. FEV1 ≥ 40% predicted and \< 100% predicted in the last 12 months.
4. 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 Criteria:
1. Severe or unstable CF at screening or Visit 1.
2. Any of the following values for laboratory tests at screening:
1. A positive pregnancy test.
2. Hemoglobin \< 10 g/dL in males and \< 9 g/dL in females.
3. Neutrophils \< 1.0 x 10\^9 /L.
4. Platelets \< 75 x 10\^9/L.
5. Creatinine clearance \< 50 mL/min according to Modification of Diet in Renal Disease (MDRD) Study equation.
6. Serum transaminases \> 2.5 x upper limit of normal.
3. 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.
Intervention
Intervention Type
Intervention Name
DRUG
Lenabasum 20 mg
DRUG
Lenabasum 5 mg
OTHER
Placebo
Phase
PHASE2
Gender
ALL
Min Age
12 Years
Max Age
N/A
Download Date
2023-01-18
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: