Clinical trial Recruiting at 1 site Observational Ages 18 and up

Different forms of IgE in health and disease.

Official title: Analysis of the Role of IgE Proteoforms in Health and Disease

Run by KU Leuven · NCT07328178 · Data updated 2026-11-12

We will test whether different forms of IgE in the blood differ between healthy adults and people with allergies, chronic spontaneous urticaria, recent anaphylaxis, mastocytosis, hereditary alpha tryptasemia, X‑linked agammaglobulinemia, or those undergoing venom/medication desensitization.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorKU Leuven
Academic / other
Locations1 site (Leuven, Vlaams-Brabant)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedJanuary 1, 2029
Study endsJanuary 1, 2029
Registry record updatedJanuary 9, 2026
Trial IDNCT07328178 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18 or older) who can give informed consent and who have CSU, type I allergic diseases including recent anaphylaxis or desensitization, atopic dermatitis, mastocytosis, hereditary alpha tryptasemia, X‑linked agammaglobulinemia, or age‑ and gender‑matched healthy controls are appropriate candidates.

Probably not a fit

People under 18 years old, those unable to give informed consent, or patients expecting direct therapeutic benefit from participation are unlikely to gain personal medical benefit from this observational protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study that collects blood samples from adult patients with various IgE‑related conditions and from age‑ and gender‑matched healthy controls at UZ/KU Leuven. Researchers will profile IgE proteoforms (molecular variants of IgE) to compare patterns across clinical groups. Clinical history and laboratory information will be recorded to link proteoform patterns to disease features such as recent anaphylaxis or ongoing desensitization. No investigational treatments are given; the focus is molecular characterization of patient samples.

Why it matters

Potential benefit: If successful, the findings could identify IgE molecular patterns that improve diagnosis, risk stratification, or personalization of allergy and mast cell disease care.

How similar studies have gone: Related work on IgE variants and glycosylation has provided biological insights, but comprehensive proteoform profiling in these patient groups is still relatively novel and not yet proven to change clinical care.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • UZ/KU Leuven
    Leuven, Vlaams-Brabant, Belgium
    Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.