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A Two-center, Double Blind, Placebo-controlled Study in Parallel Design to Assess the Efficacy and Safety of 150 and 300 mg Omalizumab in Subjects With Antihistamine-resistant Cold Contact Urticaria (CCU)

Trial Profile

A Two-center, Double Blind, Placebo-controlled Study in Parallel Design to Assess the Efficacy and Safety of 150 and 300 mg Omalizumab in Subjects With Antihistamine-resistant Cold Contact Urticaria (CCU)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 10 Apr 2017

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At a glance

  • Drugs Omalizumab (Primary)
  • Indications Cold Urticaria
  • Focus Therapeutic Use
  • Acronyms CUTEX

Most Recent Events

  • 04 Apr 2017 According to the results published in the Journal of Allergy and Clinical Immunology, status changed from active, no longer recruiting to discontinued, as the study met its primary endpoint at the planned interim analysis
  • 04 Apr 2017 Primary endpoint (Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo) has been met, according to the results published in the Journal of Allergy and Clinical Immunology
  • 04 Apr 2017 Results published in the Journal of Allergy and Clinical Immunology

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