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NCT01545453 · ClinicalTrials.gov registry record · Phase 2
A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT01545453 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 205 participants.
The verdict
NCT01545453, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 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 | 205 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01545453
The ClinicalTrials.gov registry entry for NCT01545453 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01545453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01545453 about?
NCT01545453 is a clinical study titled "A Study of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication (VERSE)". 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 NCT01545453?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2012-03. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01545453?
The interventions under investigation include: placebo (DRUG), lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01545453?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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