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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 is a Phase 2 study that has completed, run by Corbus Pharmaceuticals. The registered enrollment target is 447 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03451045
The ClinicalTrials.gov registry entry for NCT03451045 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 447 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corbus Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03451045 reports 0 study locations.
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.
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