ClinicalTrials.gg
RecruitingNCT07328178IgE-PhDUpdated Jan 9, 2026

Analysis of the Role of IgE Proteoforms in Health and Disease

An observational study in Anaphylaxis, Mastocytosis and X-linked Agammaglobulinaemia, sponsored by KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by KU Leuven · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Anaphylaxis
  • Mastocytosis
  • X-linked Agammaglobulinaemia
  • Venom Allergy
  • Chronic Spontaneous Urticaria (CSU)
  • Type I Allergy
  • Medication Allergy
  • Healthy Control
  • Hereditary Alpha-Tryptasemia
03

In context

Anaphylaxis

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's planned enrollment of 200 is above the median of 137 across 48 observational studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CSU and type I allergic diseases (including anaphylaxis and desensitization), atopic dermatitis, mastocytosis, XLA and HaT (, 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

Exclusion Criteria:

  • Absence of
  • Age \< 18 years old
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy controls

    Other: Blood sample collection

  • Patients with type I allergy

    Including medication allergy, venom allergy, food allergy, allergic rhinitis

    Other: Blood sample collection

  • Patients with chronic spontaneous urticaria

    With or without omalizumab

    Other: Blood sample collection

  • Patients with a recent history of anaphylaxis

    In whom serial sampling can be performed

    Other: Blood sample collection

  • Patients undergoing desensitization for venom allergy

    Other: Blood sample collection

  • Patients undergoing desensitization for medication allergy

    Other: Blood sample collection

  • Patients with mastocytosis

    Other: Blood sample collection

  • Patients with hereditary alpha tryptasemia

    Other: Blood sample collection

  • Patients with X-linked agammaglobulinemia (XLA)

    Other: Blood sample collection

Interventions

  • OtherBlood sample collection

    Blood sample collection

This study also gives Omalizumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Evaluation of IgE proteoforms

    Time frame: 4 years

07

Study locations

1 of 1 sites recruiting
  • UZ/KU Leuven
    Leuven, Vlaams-Brabant 3000, Belgium
    Recruiting
    • Rik Schrijvers, MD, PhD · Contactrik.schrijvers@uzleuven.be · 016342985
    • Dries Wets, MD · Contactdries.wets@kuleuven.be · 016338198
    • Rik Schrijvers, MD, PhD · Principal investigator
    • Paul Proost, PhD · Sub investigator
    • Frans Glynis, PharmD, PhD, · Sub investigator
    • Christine Breynaert, MD, PhD · Sub investigator
    • Dries Wets, MD · Sub investigator
    • Rafaela Vaz Pereira, PhD · Sub investigator
    • Toon Ieven, MD, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Jan 2029, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2025
First posted
Jan 9, 2026
StartActual
Jan 1, 2025
Primary completionEst.
Jan 1, 2029
CompletionEst.
Jan 1, 2029
Last update
Jan 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07328178
Lead sponsor
KU Leuven
Responsible party
Rik Schrijvers (Prof. Dr. Rik Schrijvers, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Jan 9, 2026
Start date
Jan 1, 2025
Primary completion
Jan 1, 2029 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Jan 9, 2026

Study contacts

Rik Schrijvers, MD, PhD
principal investigator · UZ/KU Leuven

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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