Analysis of the Role of IgE Proteoforms in Health and Disease (IgE-PhD)

December 26, 2025 updated by: Rik Schrijvers, KU Leuven
The goal of this observational study is to evaluate the role of IgE proteoforms in healthy volunteers and in patients with type I allergy, patients with chronic spontaneous urticaria, patients with a recent history of anaphylaxis, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), and patients undergoing desensitization for venom or medication allergy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ/KU Leuven
        • Sub-Investigator:
          • Christine Breynaert, MD, PhD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rik Schrijvers, MD, PhD
        • Sub-Investigator:
          • Paul Proost, PhD
        • Sub-Investigator:
          • Frans Glynis, PharmD, PhD,
        • Sub-Investigator:
          • Dries Wets, MD
        • Sub-Investigator:
          • Rafaela Vaz Pereira, PhD
        • Sub-Investigator:
          • Toon Ieven, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with type I allergy (including medication allergy, venom allergy, food allergy, allergic rhinitis), patients with chronic spontaneous urticaria (with or without omalizumab), patients with a recent history of anaphylaxis in whom serial sampling can be performed, patients undergoing desensitization for venom allergy, patients undergoing desensitization for medication allergy, patients with mastocytosis, patients with hereditary alpha tryptasemia, patients with X-linked agammaglobulinemia (XLA), healthy controls

Description

Inclusion Criteria:

  • CSU and type I allergic diseases (including anaphylaxis and desensitization), atopic dermatitis, mastocytosis, XLA and HaT (informed consent, age: any available adult subject, gender: any available subject, clinical phenotype and specific information about the allergy (e.g. severity, medication, medical history, laboratory testing)
  • Healthy controls (informed consent, age matched to the allergic patients, gender matched to the allergic patients, patient-reported symptoms related to allergy to aeroallergens, food, drugs, hymenoptera venom, CSU)

Exclusion Criteria:

  • Absence of informed consent
  • Age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
Other: Blood sample collection
Blood sample collection
Patients with type I allergy
Including medication allergy, venom allergy, food allergy, allergic rhinitis
Other: Blood sample collection
Blood sample collection
Patients with chronic spontaneous urticaria
With or without omalizumab
Other: Blood sample collection
Blood sample collection
Patients with a recent history of anaphylaxis
In whom serial sampling can be performed
Other: Blood sample collection
Blood sample collection
Patients undergoing desensitization for venom allergy
Other: Blood sample collection
Blood sample collection
Patients undergoing desensitization for medication allergy
Other: Blood sample collection
Blood sample collection
Patients with mastocytosis
Other: Blood sample collection
Blood sample collection
Patients with hereditary alpha tryptasemia
Other: Blood sample collection
Blood sample collection
Patients with X-linked agammaglobulinemia (XLA)
Other: Blood sample collection
Blood sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of IgE proteoforms
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Rik Schrijvers, MD, PhD, UZ/KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S69940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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