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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,081 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01867125
The ClinicalTrials.gov registry entry for NCT01867125 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,081 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01867125 reports 0 study locations.
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.
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