A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
Public ClinicalTrials.gov record NCT01868061. 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 Efficacy and Safety 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 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.
Study identification
- NCT ID
- NCT01868061
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,068 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
- Jul 31, 2013 (Actual)
- Primary completion
- Jan 2, 2017 (Actual)
- Completion
- Jan 2, 2017 (Actual)
- Last update posted
- May 19, 2017
2013 – 2017
United States locations
- U.S. sites
- 66
- U.S. states
- 30
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | — |
| Medical Research of Arizona; Allergy, Asthma & Immu | Scottsdale | Arizona | 85251 | — |
| Quality of Life Medical & Research Center | Tucson | Arizona | 85712 | — |
| Kern Allergy Med Clinic, Inc. | Bakersfield | California | 93301 | — |
| Allergy and Asthma Relief Experts | Granada Hills | California | 91344 | — |
| Southern California Institute For Respiratory | Los Angeles | California | 90048 | — |
| Allergy & Asthma Consultants | Redwood City | California | 94063 | — |
| Integrated Research Group Inc | Upland | California | 91786 | — |
| Allergy & Asthma Medical Group; Clinical Research Division | Walnut Creek | California | 94598 | — |
| Asthma & Allergy; Associates, P.C. | Colorado Springs | Colorado | 80907 | — |
| Storms Clinical Research; Institute | Colorado Springs | Colorado | 80907 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Colorado Allergy & Asthma Centers, Pc | Denver | Colorado | 80230 | — |
| Western States Clinical Research, Inc | Wheat Ridge | Colorado | 80033 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | — |
| Allergy Consultants PA | Boca Raton | Florida | 33431 | — |
| Research Institute of South Florida Inc | Miami | Florida | 33173 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | — |
| Georgia Pollens | Albany | Georgia | 31707 | — |
| Brookstone Clinical Res Ctr | Columbus | Georgia | 31904 | — |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | — |
| DataQuest Medical Research | Lawrenceville | Georgia | 30045 | — |
| Aeroallergy Research Labs | Savannah | Georgia | 31406 | — |
| Atlanta Allergy & Asthma Clini | Woodstock | Georgia | 30188 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Asthma & Allergy of Idaho | Twin Falls | Idaho | 83301 | — |
| The Allergy and Asthma Center | Fort Wayne | Indiana | 46804 | — |
| Cotton O'Neil Clinic; Stormont-Vail Hlth Care | Topeka | Kansas | 66606 | — |
| Dr. Paul Shapero | Bangor | Maine | 04401 | — |
| Asthma, Allergy & Sinus Center | Baltimore | Maryland | 21236 | — |
| Chesapeake Clinical Research | Baltimore | Maryland | 21236 | — |
| Howard County Center for Lung and Sleep, LLC | Columbia | Maryland | 21044 | — |
| Infinity Medical Research Inc | North Dartmouth | Massachusetts | 02747 | — |
| Clinical Research Inst | Minneapolis | Minnesota | 55402 | — |
| Asthma and Allergy Physicians LLC | Brockton | Mississippi | 02301 | — |
| Allergy Associates, Inc. | Chesterfield | Missouri | 63017 | — |
| Center For Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Clinical Research Center, L.L.C. | St Louis | Missouri | 63141 | — |
| Clinical Research Consortium | Las Vegas | Nevada | 89119 | — |
| Adult Pediatric Allergy Central Jersey | Edison | New Jersey | 08820 | — |
| Patrick V. Perin, MD | Teaneck | New Jersey | 07666 | — |
| University of New Mexico; School of Med | Albuquerque | New Mexico | 87131 | — |
| Winthrop Univ Hospital | Mineola | New York | 11501 | — |
| Allergy Partners of Western NC | Asheville | North Carolina | 28801 | — |
| Allergy & Asthma Centre of Dayton | Centerville | Ohio | 45458 | — |
| Integrity People Services Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Oklahoma Institute of Allergy and Asthma Clinical Research LLC | Oklahoma City | Oklahoma | 73131 | — |
| Vital Prospects Clin Res Pc | Tulsa | Oklahoma | 74136 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| Asthma and Allergy Research Associates | Upland | Pennsylvania | 19013 | — |
| Neem Research Group, Inc. | Columbia | South Carolina | 29201 | — |
| Greenville Pharmaceutical Research | Greenville | South Carolina | 29615 | — |
| Upstate Pharmaceutical Research; Greenville | Greenville | South Carolina | 29615 | — |
| Future Search Clinical Trials L.P. | Austin | Texas | 78756 | — |
| Elliot J. Ginchansky, MD, PA | Dallas | Texas | 75230 | — |
| EPIMRD, Inc. DBA Western Sky Medical Research | El Paso | Texas | 79903 | — |
| Baylor College of Medicine; Dept of Medicine | Houston | Texas | 77030 | — |
| Allergy & Asthma Clin Cen TX | Round Rock | Texas | 78681 | — |
| Quality Assurance Research Ctr | San Antonio | Texas | 78205 | — |
| Discovery Clinical Trials | San Antonio | Texas | 78224 | — |
| Allergy & Asthma Research Center | San Antonio | Texas | 78229 | — |
| Live Oak Allergy & Asthma Clinic | San Antonio | Texas | 78233 | — |
| Allergy Associates of Utah | Murray | Utah | 84107 | — |
| Pulmonary Research of Albingdon | Abingdon | Virginia | 24210 | — |
| University of Wisconsin;Allergy & Asthma Clinical Research | 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 166 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01868061, 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 May 19, 2017 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01868061 live on ClinicalTrials.gov.