Lebrikizumab
DrugLebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Other names: RO5490255
NCT Number: NCT02099656
This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
University of Calgary, Calgary, Alberta, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Other names: RO5490255
Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: Form Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 12
Time frame: From Baseline to Week 20
Time frame: Baseline up to Week 20 (assessed at Baseline, Weeks 8 and 20/dosing termination or early termination)
Time frame: Predose (Hour 0) at Week 12
Hoffmann-La Roche
Industry
A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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