Investigation of cytokinergicity and glycosylation Profile of IgE in chronic urticaria compared to allergy sufferers and healthy volunteers

• Conditions: L50.8; T78.4; Other urticaria; Allergy, unspecified

• Registration Number: DRKS00017617
• Lead Sponsor: Charité-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Healthy volunteers or Patients suffering from one of the following diseases:
- Chronic urticaria
- allergy sufferers (allergic rhinoconjunctivitis, allergic asthma)

Furthermore:
- Adult
- Time of diagnosis of the disease > 3 months
- For women of childbearing age: negative pregnancy test
- Patients may have additional concomitant diseases, but only a dominant skin disease
- No participation in other clinical trials 4 weeks before

Exclusion Criteria

- Simultaneous/continuous treatment with immunosuppressants (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half-lives prior to study start, whichever is longer
- Simultaneous/continuous treatment with omalizumab, dupilumab or other Biologics within 3 months before start of study
- breast-feeding or pregnant women
- Participation in another study with an investigational drug; participation less than 4 weeks or 5 half-lives of the investigational drug, whichever is longer
- Persons who have concerns about compliance with the study procedure
- Any disease which, in the opinion of the investigator, would impair participation in the study or put the person at risk
- Persons who are officially or legally detained in a public facility
- Taking leukotriene antagonists within 7 days of study initiation
- History of drug abuse (drugs or alcohol) or other factors (e.g. severe psychiatric illness) that may limit the subjects' ability to participate in the study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The autoreactive IgE will be characterized better with regard to their antigen recognition and the different cell activation patterns (cytokinergicity) compared to exo-allergenic IgE will be determined.<br>Participants will undergo once blood drawing, physical examination and will answer questionnaires regarding their disease.

Secondary Outcome Measures

Name	Time	Method
Correlation of autoreactivity of IgE against autoantigens with disease activity, duration of disease and pathological relevance.