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NCT03451045 · ClinicalTrials.gov registry record · Phase 2
Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis
A Phase 2 study, sponsored by Corbus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 447
- Enrollment target
NCT03451045: Completed Phase 2 study, sponsored by Corbus Pharmaceuticals.
NCT03451045 is a Phase 2 study that has completed, run by Corbus Pharmaceuticals. The registered enrollment target is 447 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (236% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03451045, a Phase 2 study, has completed, sponsored by Corbus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 447 participants
- Enrollment target
Study 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.
Primary Outcome
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 o
Interventions
- OTHER Placebo
- DRUG Lenabasum 20 mg
- DRUG Lenabasum 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2020-06-17 |
| Phase | Phase 2 |
What the finished NCT03451045 record still lists
NCT03451045 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (236% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03451045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03451045 about?
NCT03451045 is a clinical study titled "Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis". 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, a...
What is the current status of trial NCT03451045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 447 participants. The study started on 2017-12-22. Estimated completion is 2020-06-17.
What interventions are being tested in trial NCT03451045?
The interventions under investigation include: Placebo (OTHER), Lenabasum 20 mg (DRUG), Lenabasum 5 mg (DRUG).
Who is sponsoring clinical trial NCT03451045?
This trial is sponsored by Corbus Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03451045's enrollment target sits among peer trials
447 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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