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

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ClinicalTrials.gov Identifier: NCT01803763
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : April 15, 2014
Sponsor:
Collaborators:
Adverse Drug Reactions, Advice and Consulting ADR-AC
University of Bern
Novartis
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Urticaria Chronic Idiopathic Urticaria Chronic Spontaneous Urticaria Drug: Omalizumab (Xolair) Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients
Study Start Date : September 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Omalizumab (Xolair)
Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses
Drug: 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
Drug: Placebo
Fixed dose of placebo is subcutaneously administered in total 4 monthly doses



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change of responsiveness to Fc-IgE cross-linking dependent stimuli (anti-IgE, Allergen induced IgE-cross-linking in grass or birch pollen allergic patients) [ Time Frame: Once before treatment, 1 week and 3 months after treatment start ]
  2. Comparison of serum of visit 1 and 6 on third party basophils (CD63 upregulation on basophils) [ Time Frame: Once before treatment and 3 months after treatment start ]
  3. Measurement of IL-3 hyperresponsiveness of basophils [ Time Frame: Day of the first treatment, 1 week and 3 months after treatment start ]
  4. Urticaria activity score [ Time Frame: At 1, 2, 3, 4 and 6 months ]
  5. German version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) [ Time Frame: At 1, 2, 3, 4 and 6 months ]
  6. Medication use [ Time Frame: At 1, 2, 3, 4 and 6 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Diagnosis of chronic urticaria made by clinical symptoms and clinical investigations
  • 2. Patients with chronic urticaria were defined as having symptoms for at least 6 weeks, with hives present at least twice weekly, refractory to H1 antihistaminics at time of randomization
  • 3. Signed informed consent documenting understanding of the study procedures and the investigational nature of the study

Exclusion Criteria

  • Age <18 or >70 year
  • Patients with pure physical or cold urticaria, delayed pressure or cholinergic urticaria
  • Patients with a clearly defined allergic urticaria (food, drugs etc.)
  • Previous treatment with omalizumab within one year prior to randomization
  • Known hypersensitivity to omalizumab or any of its components
  • History of cancer in the previous 5 years
  • Patients with parasitic infections
  • Patients with documented active tuberculosis or undergoing anti-TB therapy
  • Patients currently or recently (in the preceding 4 weeks) treated with systemic immunosuppressive agents according to medical history
  • Pregnant or nursing women
  • Known intolerance to any protocol intervention
  • Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the study and to formulate his/her own wishes correspondingly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803763


Locations
Switzerland
Department of Rheumatology, Clinical Immunology and Allergology, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Adverse Drug Reactions, Advice and Consulting ADR-AC
University of Bern
Novartis
Investigators
Principal Investigator: Oliver Hausmann Department of Rheumatology, Clinical Immunology and Allergology, Bern University Hospital

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01803763     History of Changes
Other Study ID Numbers: 199/10
CIGE025ECH04T ( Other Identifier: Swissmedic )
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014

Keywords provided by University Hospital Inselspital, Berne:
Omalizumab
Xolair
Urticaria
basophils
chronic Urticaria
Fc Receptor

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents