Lebrikizumab
DrugLebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Other names: RO5490255
NCT Number: NCT01868061
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 as subcutaneous (SC) injection 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. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Fundacion Cidea, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
Other names: RO5490255
Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Time frame: Baseline up to Week 52
Time frame: Baseline, Week 52
Time frame: Baseline up to Week 52
Time frame: Baseline, Week 52
Time frame: Baseline, Week 52
Time frame: Baseline up to Week 52
Time frame: Baseline up to Week 124
Time frame: Baseline up to Week 124 (assessed at Baseline, Weeks 4, 12, 24, 36, 52, 64, 76, 92, 104, 112, and 124)
Time frame: Baseline, Week 52
Time frame: Predose (0 hour) on Weeks 4, 12, 24, 36, and 52
Hoffmann-La Roche
Industry
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
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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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