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NCT01875003 · ClinicalTrials.gov registry record · Phase 3
A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
A Phase 3 study of Asthma, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
- 20
- Study locations
NCT01875003: Completed Phase 3 study of Asthma, sponsored by Hoffmann-La Roche.
NCT01875003 is a Phase 3 study of Asthma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 348 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01875003, a Phase 3 study of Asthma, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
An asthma exacerbation is defined as new or increased asthma symptoms (including wheeze, cough, dyspnea, chest tightness, and/or night-time awakening due to these symptoms) that lead to treatment with systemic corticosteroids or to hospitalization. Treatment with systemic corticosteroids is defined as treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids for at least 3 days or an emergency department visit with at least 1 dose of IV or IM corticosteroids. Rate of asthma ex
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Standard of Care
- DRUG Lebrikizumab
Study Locations (20)
California
- Kaiser Permanente Los Angeles - Los Angeles
- Southern California Research Center - Mission Viejo
- Allergy & Asthma Consultants - Redwood City
- Dignity Health Medical Foundation - Sacramento
- Bensch Research Associates - Stockton
- Allergy & Asthma Medical Group; Clinical Research Division - Walnut Creek
Colorado
- Colorado Children's Hospital; The Breathing Institute - Aurora
- IMMUNOe International Research Centers - Centennial
- Asthma & Allergy; Associates, P.C. - Colorado Springs
- National Jewish Medical and Research Center - Denver
Florida
- Abel and Buchheim - Miami
- Compass Research East, LLC - Orlando
- Sarasota Clinical Research - Sarasota
- University of South Florida - Tampa
Georgia
- Brookstone Clinical Res Ctr - Columbus
- Georgia Pain Clinic - Marietta
Illinois
- Rush University Medical Center - Chicago
- The Clinical Research Center - Shiloh
Arizona
- Allergy Associates of Tucson - Tucson
Indiana
- Riley Hospital for Children; Pediatric Nephrology - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2013-08-31 |
| Est. Completion | 2016-12-28 |
| Phase | Phase 3 |
What the finished NCT01875003 record still lists
NCT01875003 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01875003 names 20 study sites across 7 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01875003 about?
NCT01875003 is a clinical study titled "A Study of Lebrikizumab in Adolescent Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication". 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 a...
What is the current status of trial NCT01875003?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2013-08-31. Estimated completion is 2016-12-28.
What conditions does trial NCT01875003 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01875003?
The interventions under investigation include: Placebo (DRUG), Standard of Care (DRUG), Lebrikizumab (DRUG).
Who is sponsoring clinical trial NCT01875003?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01875003 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01875003's enrollment target sits among peer trials
348 106th of 374 higher than 269 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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