A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Public ClinicalTrials.gov record NCT01867125. 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 subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 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
- NCT01867125
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,081 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 25, 2013 (Actual)
- Primary completion
- Dec 28, 2016 (Actual)
- Completion
- Dec 28, 2016 (Actual)
- Last update posted
- Jul 17, 2026
2013 – 2016
United States locations
- U.S. sites
- 53
- U.S. states
- 24
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Research Associates | Pell City | Alabama | 35128 | — |
| Desert Sun Clinical Research LLC | Tucson | Arizona | 85710 | — |
| Allianz Medical and Research Center | Fountain Valley | California | 92708 | — |
| Allergy & Asthma Medical Group & Research Center, Pc | Long Beach | California | 90808 | — |
| Allergy Medical Clinic | Los Angeles | California | 90025 | — |
| CA Allergy & Asthma Med Grp | Los Angeles | California | 90025 | — |
| North Bay Clinical Trials | Napa | California | 94558 | — |
| Choc Psf, Amc | Orange | California | 92868 | — |
| Advances in Medicine | Rancho Mirage | California | 92270 | — |
| Allergy Assoc Medical Group | San Diego | California | 92108 | — |
| Bensch Research Associates | Stockton | California | 95207 | — |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | — |
| Waterbury Pulmonary Associates | Waterbury | Connecticut | 06708 | — |
| St. Francis Sleep; Allergy & Lung Institute | Clearwater | Florida | 33765 | — |
| Suncoast Research Group LLC | Miami | Florida | 33135 | — |
| Emerald Coast Research Associates | Panama City | Florida | 32405 | — |
| Allergy & Asthma Diagnostic; Treatment Center | Tallahassee | Florida | 32308 | — |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | — |
| Atlanta Allergy & Asthma Clini | Woodstock | Georgia | 30188 | — |
| Northeast Medical Research Associates, Inc | North Dartmouth | Massachusetts | 02747 | — |
| Midwest Clinical Research LLC | St Louis | Missouri | 63141 | — |
| Montana Medical Research LLC | Missoula | Montana | 59808 | — |
| Heartland Clinical Research Inc. | Omaha | Nebraska | 68134 | — |
| Asthma & Allergy Center, P.C. | Papillion | Nebraska | 68046 | — |
| Allergy & Asthma Associates | Las Vegas | Nevada | 89104 | — |
| Allergy & Asthma Research of Nj, Inc | Mount Laurel | New Jersey | 08054 | — |
| Atlantic Research Center, LLC | Ocean City | New Jersey | 07712 | — |
| Princeton Center For Clinical Research | Skillman | New Jersey | 08558 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Allergy & Asthma Center of NC | High Point | North Carolina | 27262 | — |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | — |
| Asthma & Allergy Center | Toledo | Ohio | 43617 | — |
| Cor Clinical Research | Oklahoma City | Oklahoma | 73103 | — |
| Allergy & Asthma Research Grp | Eugene | Oregon | 97401-7721 | — |
| Clinical Research Inst. of Southern Oregon, Pc | Medford | Oregon | 97504 | — |
| Allergy Associates Research Center LLC - CRN | Portland | Oregon | 97202 | — |
| Asthma Allergy Pulm Associates | Philadelphia | Pennsylvania | 19107 | — |
| Grand View Hospital; Clinical Research Department | Sellersville | Pennsylvania | 18960 | — |
| Asthma Allergy Phys of RI | Lincoln | Rhode Island | 02865 | — |
| ADAC Research PA | Greenville | South Carolina | 29607 | — |
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | — |
| Tekton Research Inc | Austin | Texas | 78745 | — |
| TTS Research | Boerne | Texas | 78006 | — |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 75231 | — |
| Pioneer Research Solutions | Houston | Texas | 077099 | — |
| Metroplex Pulmonology & Sleep Center | McKinney | Texas | 75069 | — |
| Quality Assurance Research Ctr | San Antonio | Texas | 78205 | — |
| O & O Alpan, LLC | Fairfax | Virginia | 22030 | — |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23220 | — |
| Bellingham Asthma, Allergy & Immunology | Bellingham | Washington | 98225 | — |
| ASTHMA, Inc | Seattle | Washington | 98105 | — |
| Premier Clinical Research | Spokane | Washington | 99202 | — |
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 128 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01867125, 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 Jul 17, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01867125 live on ClinicalTrials.gov.