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A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

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Trial Profile

A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2021

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At a glance

  • Drugs Tralokinumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms STRATOS2
  • Sponsors AstraZeneca

    • Most Recent Events

    • 06 Aug 2021 Results of a pooled analysis predicting asthma attacks based on the blood eosinophil count and exhaled nitric oxide from following clinical studies: Novel START, CAPTAIN, QUEST, Benralizumab Phase 2b, PATHWAY, STRATOS 1 & 2 and DREAM using biomarker-stratified trial-level attack rates published in the Thorax
    • 20 May 2020 Result (N=2016), of a pooled analysis of (SIROCCO, CALIMA, Phase IIb of Bernalizumab, Tralokinumab's STRATOS I, II and Phase IIb and tezepelumab Phase II PATHWAY) assessing clinical characteristics and biomarkers associated with exacerbation risk, presented at the 116th International Conference of the American Thoracic Society
    • 23 May 2018 Results of an analysis assessing the efficacy and safety of Tralokinumab in two phase III trials of severe, uncontrolled asthma (STRATOS 1 tralokinumab Q2W treatment group (all-comers N=398; FeNO-high N=92) and the STRATOS 2 FeNO-high cohort (N=108)), presented at the 114th International Conference of the American Thoracic Society.

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