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

NCT01803763 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Omalizumab (Xolair)

Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses

DRUG

Placebo

Fixed dose of placebo is subcutaneously administered in total 4 monthly doses

Sponsors & Collaborators

  • Adverse Drug Reactions, Advice and Consulting ADR-AC

    collaborator UNKNOWN

  • University of Bern

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Oliver Hausmann · Department of Rheumatology, Clinical Immunology and Allergology, Bern University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01803763 on ClinicalTrials.gov