A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)
Public ClinicalTrials.gov record NCT01545440. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01545440
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 258 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2012 (Type not available)
- Primary completion
- Mar 2013 (Actual)
- Completion
- Jul 2013 (Actual)
- Last update posted
- Mar 5, 2015
2012 – 2013
United States locations
- U.S. sites
- 70
- U.S. states
- 28
- U.S. cities
- 66
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Pell City | Alabama | 35128 | — |
| Not listed | Scottsdale | Arizona | 85251 | — |
| Not listed | Scottsdale | Arizona | 85266 | — |
| Not listed | Tucson | Arizona | 85712 | — |
| Not listed | Bakersfield | California | 93301 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Fullerton | California | 92835 | — |
| Not listed | Los Angeles | California | 90025 | — |
| Not listed | Los Angeles | California | 90048 | — |
| Not listed | Mission Viejo | California | 92691 | — |
| Not listed | Napa | California | 94558 | — |
| Not listed | Orange | California | 92868 | — |
| Not listed | Rancho Mirage | California | 92270 | — |
| Not listed | Sacramento | California | 95819 | — |
| Not listed | San Diego | California | 92108 | — |
| Not listed | Studio City | California | 91607 | — |
| Not listed | Upland | California | 91786 | — |
| Not listed | Walnut Creek | California | 94598 | — |
| Not listed | Centennial | Colorado | 80112 | — |
| Not listed | Colorado Springs | Colorado | 80907 | — |
| Not listed | Denver | Colorado | 80206 | — |
| Not listed | Wheat Ridge | Colorado | 80033 | — |
| Not listed | Waterbury | Connecticut | 06708 | — |
| Not listed | Gainesville | Florida | 32605 | — |
| Not listed | North Palm Beach | Florida | 33408 | — |
| Not listed | Ocala | Florida | 34471 | — |
| Not listed | Tallahassee | Florida | 32308 | — |
| Not listed | Tampa | Florida | 33613 | — |
| Not listed | Winter Park | Florida | 32789 | — |
| Not listed | Albany | Georgia | 31707 | — |
| Not listed | Savannah | Georgia | 31406 | — |
| Not listed | Honolulu | Hawaii | 96814 | — |
| Not listed | River Forest | Illinois | 60305 | — |
| Not listed | Topeka | Kansas | 66606 | — |
| Not listed | Metairie | Louisiana | 70006 | — |
| Not listed | Bangor | Maine | 04401 | — |
| Not listed | Kansas City | Missouri | 64114 | — |
| Not listed | Bellevue | Nebraska | 68123 | — |
| Not listed | Las Vegas | Nevada | 89106 | — |
| Not listed | Las Vegas | Nevada | 89119 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | Great Neck | New York | 11021 | — |
| Not listed | New York | New York | 10016 | — |
| Not listed | Rockville Centre | New York | 11570 | — |
| Not listed | The Bronx | New York | 10461 | — |
| Not listed | High Point | North Carolina | 27262 | — |
| Not listed | Wilmington | North Carolina | 28401 | — |
| Not listed | Cincinnati | Ohio | 45231 | — |
| Not listed | Eugene | Oregon | 97401-7721 | — |
| Not listed | Lake Oswego | Oregon | 97035 | — |
| Not listed | Portland | Oregon | 97202 | — |
| Not listed | Blue Bell | Pennsylvania | 19422 | — |
| Not listed | Easton | Pennsylvania | 18045 | — |
| Not listed | Harrisburg | Pennsylvania | 17110 | — |
| Not listed | Philadelphia | Pennsylvania | 19115 | — |
| Not listed | Upland | Pennsylvania | 19013 | — |
| Not listed | Warwick | Rhode Island | 02865 | — |
| Not listed | Greenville | South Carolina | 29607 | — |
| Not listed | Spartanburg | South Carolina | 29303 | — |
| Not listed | Knoxville | Tennessee | 37909 | — |
| Not listed | Arlington | Texas | 76018 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | El Paso | Texas | 79925 | — |
| Not listed | Fort Worth | Texas | 76109 | — |
| Not listed | McKinney | Texas | 75069 | — |
| Not listed | San Antonio | Texas | 78224 | — |
| Not listed | San Antonio | Texas | 78251 | — |
| Not listed | Henrico | Virginia | 23233 | — |
| Not listed | Seattle | Washington | 98105 | — |
| Not listed | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01545440, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 5, 2015 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01545440 live on ClinicalTrials.gov.