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NCT02104674 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
NCT02104674: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT02104674 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 313 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02104674, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
Study Summary
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.
Primary Outcome
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. The active comparator treatment arm of open-label montelukast was included in the study design so that the sensitivity of the study could be evaluated with respect to the primary outcome measure, FEV1. Two mixed-effect models of repeated measures (MMRM) were used to estimate the absolute change from baseline values: one for the lebrikizumab vs. placebo primary comparison and the sec
Interventions
- OTHER placebo
- DRUG lebrikizumab
- DRUG montelukast [Singulair]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT02104674 record still lists
NCT02104674 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT02104674 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02104674 about?
NCT02104674 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma". This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive eith...
What is the current status of trial NCT02104674?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2014-06. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02104674?
The interventions under investigation include: placebo (OTHER), lebrikizumab (DRUG), montelukast [Singulair] (DRUG).
Who is sponsoring clinical trial NCT02104674?
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 NCT02104674's enrollment target sits among peer trials
313 1101st of 2000 higher than 899 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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