A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Phase 3 Completed NCT01867125

Summary

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 subcutaneously (SC) 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. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

Adjusted Exacerbation Rate of Asthma During the 52-Week PCP

Baseline up to 52 weeks · Asthma exacerbations per person-year

Open in BENITIONS View on ClinicalTrials.gov

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• A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With C — Chiesi Farmaceutici S.p.A.
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• Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Sev — AstraZeneca
• Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma — ARS Pharmaceuticals, Inc.

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