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Ph III, 28-wk, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess Efficacy, Safety, Tolerability of SC Omalizumab in Adults and Adolescents w/ Severe Persist. Allergic Asthma & Are Inadequately Controlled Despite GINA (2002) Step 4 Tx

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Trial Profile

Ph III, 28-wk, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess Efficacy, Safety, Tolerability of SC Omalizumab in Adults and Adolescents w/ Severe Persist. Allergic Asthma & Are Inadequately Controlled Despite GINA (2002) Step 4 Tx

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2022

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Allergic asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms INNOVATE
  • Sponsors Novartis Pharmaceuticals

Most Recent Events

  • 01 Sep 2022 Results assessing the efficacy and safety of omalizumab in chinese and caucasian patients from chinese study (NCT01202903) and four studies with predominantly Caucasian patients (008, 009, EXTRA and INNOVATE) studies, published in the Asian Pacific Journal of Allergy and Immunology.
  • 28 Jan 2022 Results of pooled analysis from two studies INNOVATE (NCT00046748), EXTRA (NCT00314574) published in the Annals of Allergy, Asthma and Immunology
  • 19 May 2021 Results of post-hoc analysis of INNOVATE (NCT00046748), EXTRA (NCT00314574), and PROSPERO (NCT01922037) presented at the 117th International Conference of the American Thoracic Society.

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