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

NCT01803763 | Completed Phase 2 DMC

• 2 other identifiers: 199/10CIGE025ECH04T
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Urticaria; Chronic Idiopathic Urticaria; Chronic Spontaneous Urticaria

Keywords

Omalizumab; Xolair; Urticaria; basophils; chronic Urticaria; Fc Receptor

Outcome Measures

Primary Outcomes (1)

• Fc-IgE Receptor density change on basophils

  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 Outcomes (6)

• Change of responsiveness to Fc-IgE cross-linking dependent stimuli (anti-IgE, Allergen induced IgE-cross-linking in grass or birch pollen allergic patients)

  Once before treatment, 1 week and 3 months after treatment start

• Comparison of serum of visit 1 and 6 on third party basophils (CD63 upregulation on basophils)

  Once before treatment and 3 months after treatment start

• Measurement of IL-3 hyperresponsiveness of basophils

  Day of the first treatment, 1 week and 3 months after treatment start

• Urticaria activity score

  At 1, 2, 3, 4 and 6 months

• German version of the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)

  At 1, 2, 3, 4 and 6 months

Study Arms (2)

Omalizumab (Xolair)

ACTIVE COMPARATOR

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

Drug: Omalizumab (Xolair)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Omalizumab (Xolair) DRUG

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

Omalizumab (Xolair)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Diagnosis of chronic urticaria made by clinical symptoms and clinical investigations
• \. 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
• \. Signed informed consent documenting understanding of the study procedures and the investigational nature of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Adverse Drug Reactions, Advice and Consulting ADR-AC: collaborator
• University of Bern: collaborator
• Novartis: collaborator

Study Sites (1)

Department of Rheumatology, Clinical Immunology and Allergology, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Oliver Hausmann

  Department of Rheumatology, Clinical Immunology and Allergology, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 4, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

CH (1)