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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01875003
The ClinicalTrials.gov registry entry for NCT01875003 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 348 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (78% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.
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