A Phase IV, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Persistency of Response With or Without Xolair After Long-term Therapy (XPORT)

Trial Profile

A Phase IV, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Persistency of Response With or Without Xolair After Long-term Therapy (XPORT)

Completed
Phase of Trial: Phase IV

Latest Information Update: 05 Nov 2016

At a glance

  • Drugs Omalizumab (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Acronyms XPORT
  • Sponsors Genentech; Roche
  • Most Recent Events

    • 05 Nov 2016 Primary endpoint (Percentage of Participants Not Experiencing a Protocol-defined Severe Exacerbation During the Study) has been met, according to results published in the Journal of Allergy and Clinical Immunology.
    • 05 Nov 2016 Results analysing efficacy published in the Journal of Allergy and Clinical Immunology.
    • 01 Mar 2016 According to a Genentech media releae, the US FDA has accepted for review the company's supplemental Biologics License Application (sBLA) to extend the indication of Xolair (omalizumab) in allergic asthma to pediatric patients. The sBLA was supported by this and other phase III trials.
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