Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT01803763
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Chronic Idiopathic Urticaria
  • Chronic Spontaneous Urticaria
  • Chronic Urticaria

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab (Xolair) — DRUG
    Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses
  • Placebo — DRUG
    Fixed dose of placebo is subcutaneously administered in total 4 monthly doses

Study Details

The aim of this study is to investigate the pathophysiological mechanism of omalizumab in patients with documented chronic urticaria who have complaints under standard antihistamine treatment. With this study the investigators will assess the correlation between Fc-IgE receptor downregulation as well as functionality and clinical response to omalizumab treatment in patients with chronic urticaria. This may be an approach for other diseases as well, where Fc-IgE receptor crosslinking are essential. The treatment time is set for a total of 4 monthly applications of omalizumab. According to the dosage recommendations of recent studies, fixed doses of 300 mg omalizumab are administered subcutaneously.

Key Dates

Start date
Sep 30, 2012
Status verified
Apr 2014
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Omalizumab (Xolair)
    Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses
  • Placebo Comparator: Placebo
    Fixed dose of Placebo is subcutaneously administered in total 4 monthly doses

Primary Outcome Measure

Fc-IgE Receptor density change on basophils [ Time Frame: Twice before (1 month before and the day of first treatment), after 1 week, after 1 and 3 months of treatment start and 2 months after stopping treatment ]

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