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

This study has been completed.
Sponsor:
Collaborators:
Adverse Drug Reactions, Advice and Consulting ADR-AC
University of Bern
Novartis
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01803763
First received: February 27, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Chronic Urticaria
Chronic Idiopathic Urticaria
Chronic Spontaneous Urticaria
Drug: Omalizumab (Xolair)
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Measurement of IL-3 hyperresponsiveness of basophils [ Time Frame: Day of the first treatment, 1 week and 3 months after treatment start ] [ Designated as safety issue: No ]
  • Urticaria activity score [ Time Frame: At 1, 2, 3, 4 and 6 months ] [ Designated as safety issue: No ]
  • German version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) [ Time Frame: At 1, 2, 3, 4 and 6 months ] [ Designated as safety issue: No ]
  • Medication use [ Time Frame: At 1, 2, 3, 4 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01803763     History of Changes
Other Study ID Numbers: 199/10, CIGE025ECH04T
Study First Received: February 27, 2013
Last Updated: April 14, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

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
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014