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A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Dec 2022

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At a glance

  • Drugs Ligelizumab (Primary) ; Omalizumab
  • Indications Chronic urticaria
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 14 Nov 2022 Results of an analysis overall HRQoL, association of SIS7 and DLQI scores with disease activity and QoL in patients with and without hives and itch presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology
    • 28 Feb 2022 Results of post-hoc analysis assessing response to ligelizumab in CSU patients who were either BHRA negative or BHRA positive at baseline, presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 28 Feb 2022 Results assessing ffect of ligelizumab, omalizumab and placebo treatment on weekly-angioedema-activity-score (AAS7) and derma-tology-life-quality-index (DLQI) of CSU patients with and without angioedema, presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.

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