Phase 2
Completed N=447
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
Source: ClinicalTrials.gov NCT03451045 ↗Enrolled (actual)
447
Serious AEs
29.4%
Results posted
Jan 2023
Primary outcomePrimary: Pulmonary Exacerbation (PEx) Rate Over 28 Weeks — 0.911; 0.749; 0.842 events per participant/28 weeks
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulmonary Exacerbation (PEx) Rate Over 28 Weeks |
0.911; 0.749; 0.842 | — |
| SECONDARY Pulmonary Exacerbation (PEx) Rate |
1.08; 0.91; 1.03 | — |
| SECONDARY Time to First New Pulmonary Exacerbation (PEx) |
162; 148; 143 | — |
| SECONDARY Pulmonary Exacerbation (PEx) |
116; 113; 120 | — |
| SECONDARY CFQ-R Respiratory Symptom Domain |
1.16; -2.92; -0.96 | — |
| SECONDARY FEV1 % Predicted |
0.014; -0.005; -0.012 | — |
Eligibility Criteria
Inclusion Criteria
- ≥ 12 years of age at the time Informed Consent/ Assent is signed.
- Weight ≥ 40 kg.
- FEV1 ≥ 40% predicted and 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.
Data sourced from ClinicalTrials.gov (NCT03451045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.