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NCT01868061 · ClinicalTrials.gov registry record · Phase 3
A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,068
- Enrollment target
NCT01868061: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01868061 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,068 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01868061, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,068 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 as subcutaneous (SC) injection 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. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 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 | 1,068 participants |
| Start Date | 2013-07-31 |
| Est. Completion | 2017-01-02 |
| Phase | Phase 3 |
What the finished NCT01868061 record still lists
NCT01868061 is an interventional study that assigns participants to a tested intervention. Its 1,068 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 (38% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01868061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01868061 about?
NCT01868061 is a clinical study titled "A Study of Lebrikizumab in Participants With Uncontrolled Asthma 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 NCT01868061?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,068 participants. The study started on 2013-07-31. Estimated completion is 2017-01-02.
What interventions are being tested in trial NCT01868061?
The interventions under investigation include: Placebo (DRUG), Lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01868061?
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 NCT01868061's enrollment target sits among peer trials
1,068 272nd of 2000 higher than 1,727 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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