AnaphylaxisIgE-PhDNCT07328178
Analysis of the Role of IgE Proteoforms in Health and Disease
An observational study of Anaphylaxis and Mastocytosis, run by KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia
- What is being tested?
- Blood sample collection
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2025to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- Absence of informed consent
- Age < 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ/KU Leuven
Leuven, Vlaams-Brabant, 3000
Rik Schrijvers, MD, PhD, 016342985, rik.schrijvers@uzleuven.be
Dries Wets, MD, 016338198, dries.wets@kuleuven.be
About this study
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.
- Conditions
- Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia, Venom Allergy, Chronic Spontaneous Urticaria (CSU), Type I Allergy
- Being tested
- Blood sample collection
- Medical subject headings
- Anaphylaxis, Mastocytosis, Bruton type agammaglobulinemia, Venom Hypersensitivity, Chronic Urticaria, Drug Hypersensitivity, Hereditary alpha-tryptasemia syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Other: Blood sample collection | |
| Patients with type I allergy | Including medication allergy, venom allergy, food allergy, allergic rhinitis Receives: Other: Blood sample collection | |
| Patients with chronic spontaneous urticaria | With or without omalizumab Receives: Other: Blood sample collection | |
| Patients with a recent history of anaphylaxis | In whom serial sampling can be performed Receives: Other: Blood sample collection | |
| Patients undergoing desensitization for venom allergy | Not described Receives: Other: Blood sample collection | |
| Patients undergoing desensitization for medication allergy | Not described Receives: Other: Blood sample collection | |
| Patients with mastocytosis | Not described Receives: Other: Blood sample collection | |
| Patients with hereditary alpha tryptasemia | Not described Receives: Other: Blood sample collection | |
| Patients with X-linked agammaglobulinemia (XLA) | Not described Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of IgE proteoforms
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rik Schrijvers, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Rik Schrijvers, MD, PhD, Principal investigator, UZ/KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328178
- Sponsor's protocol ID
- S69940
- Acronym
- IgE-PhD
- Status last verified
- Nov 2025
- First submitted
- 26 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Role of IgE Proteoforms in Health and Disease
- ClinicalTrials.gov ID
- NCT07328178
- Acronym / sponsor ID
- IgE-PhD / S69940
- Conditions
- Anaphylaxis, Mastocytosis, X-linked Agammaglobulinaemia, Venom Allergy, Chronic Spontaneous Urticaria (CSU), Type I Allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Other: Blood sample collection |
| Patients with type I allergy | – | Other: Blood sample collectionIncluding medication allergy, venom allergy, food allergy, allergic rhinitis |
| Patients with chronic spontaneous urticaria | – | Other: Blood sample collectionWith or without omalizumab |
| Patients with a recent history of anaphylaxis | – | Other: Blood sample collectionIn whom serial sampling can be performed |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Absence of informed consent
- Age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood sample collection | Other | Healthy controls, Patients undergoing desensitization for medication allergy, Patients undergoing desensitization for venom allergy, Patients with X-linked agammaglobulinemia (XLA), Patients with a recent history of anaphylaxis, Patients with chronic spontaneous urticaria, Patients with hereditary alpha tryptasemia, Patients with mastocytosis, Patients with type I allergy |
Primary outcome
Evaluation of IgE proteoforms
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rik Schrijvers, MD, PhD principal investigator
UZ/KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis and Mastocytosis, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of IgE proteoforms (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.