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NCT01867125 · ClinicalTrials.gov registry record · Phase 3
A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,081
- Enrollment target
NCT01867125: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01867125 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,081 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01867125, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,081 participants
- Enrollment target
Study Summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
Primary Outcome
Asthma exacerbation is defined as new or increased asthma symptoms (i.e., wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to systemic corticosteroid (CS) treatment (oral, intravenous (IV), or intramuscular (IM) CS for ≥ 3 days or an emergency department visit with at least one dose of IV or IM CS) or to hospitalization. Results are reported as a 'Number' representing the model-adjusted incidence rate of asthma exacerbations per person-year.
Interventions
- DRUG Placebo
- DRUG Lebrikizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,081 participants |
| Start Date | 2013-07-31 |
| Est. Completion | 2017-01-02 |
| Phase | Phase 3 |
What the finished NCT01867125 record still lists
NCT01867125 is an interventional study that assigns participants to a tested intervention. Its 1,081 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01867125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01867125 about?
NCT01867125 is a clinical study titled "A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication". This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controll...
What is the current status of trial NCT01867125?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,081 participants. The study started on 2013-07-31. Estimated completion is 2017-01-02.
What interventions are being tested in trial NCT01867125?
The interventions under investigation include: Placebo (DRUG), Lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01867125?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01867125's enrollment target sits among peer trials
1,081 269th of 2000 higher than 1,732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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