吸入ステロイド薬と別の維持療法薬を服用しているにもかかわらず喘息がコントロールされていない患者を対象としたレブリキズマブの研究

基本情報

NCT ID

NCT01868061

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,068

治験依頼者名

Hoffmann-La Roche

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (25)