Recruiting

NCT Number: NCT07328178

Analysis of the Role of IgE Proteoforms in Health and Disease

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.

Recruiting

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Key information

Conditions

Anaphylaxis Bruton type agammaglobulinemia Chemically-Induced Disorders Chronic Disease Chronic Spontaneous Urticaria (CSU) Chronic Urticaria Disease Attributes Drug Hypersensitivity Drug-Related Side Effects and Adverse Reactions Healthy Control Hereditary Alpha-Tryptasemia Hereditary alpha-tryptasemia syndrome Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Mast Cell Activation Disorders Mastocytosis Medication Allergy Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Type I Allergy Urticaria Venom Allergy Venom Hypersensitivity X-linked Agammaglobulinaemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ/KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Christine Breynaert, MD, PhD

SUB_INVESTIGATOR

Dries Wets, MD

CONTACT

[email protected]

016338198

Dries Wets, MD

SUB_INVESTIGATOR

Frans Glynis, PharmD, PhD,

SUB_INVESTIGATOR

Paul Proost, PhD

SUB_INVESTIGATOR

Rafaela Vaz Pereira, PhD

SUB_INVESTIGATOR

Rik Schrijvers, MD, PhD

CONTACT

[email protected]

016342985

Rik Schrijvers, MD, PhD

PRINCIPAL_INVESTIGATOR

Toon Ieven, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection

Other

Blood sample collection

Primary outcomes

Evaluation of IgE proteoforms

Time frame: 4 years

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: IgE-PhD

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jan 9, 2026
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed