A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Public ClinicalTrials.gov record NCT01875003. 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, Safety, and Tolerability of Lebrikizumab in Adolescent 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, safety, and tolerability of lebrikizumab in adolescent participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroids (ICS) therapy and at least one second controller medication. Participants will be randomized in a 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('High' or 'Low') or placebo, administered as subcutaneous (SC) every 4 weeks (Q4W) for 52 weeks, in addition to their standard-of-care therapy. This will be followed by an optional 52-week double-blind active-treatment extension. The anticipated time on study treatment is up to 104 weeks. Participants who complete the study to Week 104, discontinue prematurely or decide not to take part in the optional active-treatment extension will transition to the 20-week safety follow-up period.
Study identification
- NCT ID
- NCT01875003
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 346 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 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
- Aug 12, 2013
- Primary completion
- Dec 27, 2016
- Completion
- Dec 27, 2016
- Last update posted
- Jun 29, 2026
2013 – 2016
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Research Center | Mission Viejo | California | 92691 | — |
| Bensch Research Associates | Stockton | California | 95207 | — |
| Colorado Children's Hospital; The Breathing Institute | Aurora | Colorado | 80045 | — |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | — |
| Asthma & Allergy; Associates, P.C. | Colorado Springs | Colorado | 80907 | — |
| Abel and Buchheim | Miami | Florida | 33165 | — |
| Sarasota Clinical Research | Sarasota | Florida | 34239 | — |
| Georgia Pain Clinic | Marietta | Georgia | — | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Asthma, Allergy & Sinus Center | Baltimore | Maryland | 21236 | — |
| Urban Health Plan, Inc. | The Bronx | New York | 10459 | — |
| TTS Research | Boerne | Texas | 78006 | — |
| Allergy & Asthma Res Ctr PA | San Antonio | Texas | 78251 | — |
| South Texas Allergy and Asthma Medical Professionals | San Antonio | Texas | 78251 | — |
| Bridgerland Clinical Research | North Logan | Utah | 84341 | — |
| O & O Alpan, LLC | Fairfax | Virginia | 22030 | — |
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 65 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01875003, 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 Jun 29, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01875003 live on ClinicalTrials.gov.