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A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of 52 Weeks Treatment With QGE031 Subcutaneous (s.c). in Asthma Patients Not Adequately Controlled by Medium- or High-dose Inhaled Corticosteroid (ICS) Plus Long Acting β2-agonist (LABA) With or Without Oral Corticosteroid (OCS)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 27 Jul 2020

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At a glance

  • Drugs Ligelizumab (Primary)
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Novartis

    • Most Recent Events

    • 21 Feb 2017 Status changed from completed to discontinued due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). .
    • 25 Apr 2016 Status changed from recruiting to completed.
    • 14 Apr 2016 This trial was prematurely ended in Germany, Spain, Slovakia, Netherlands, Luxembourg and completed in Hungary (end date:7 Mar 2016), according to the European Clinical Trials Database

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