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NCT01545440 · ClinicalTrials.gov registry record · Phase 2
A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
NCT01545440: Completed Phase 2 study, sponsored by Genentech.
NCT01545440 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 258 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01545440, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
Study Summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.
Interventions
- DRUG placebo
- DRUG lebrikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
What the finished NCT01545440 record still lists
NCT01545440 is an interventional study that assigns participants to a tested intervention. The registered 258 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 (94% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01545440 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01545440 about?
NCT01545440 is a clinical study titled "A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)". This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will b...
What is the current status of trial NCT01545440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2012-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01545440?
The interventions under investigation include: placebo (DRUG), lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01545440?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01545440's enrollment target sits among peer trials
258 212th of 2000 higher than 1,787 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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