NCT06234761 Immunological Mechanisms Underlying Mucosal IgE Responses
| NCT ID | NCT06234761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Pathophysiology |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-01-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background / rationale: Type 2 inflammation is driving several chronic diseases in the airway. On one hand allergic rhinitis (AR) and allergic asthma (AA) are driven by allergen expose, while on the other hand eosinophilic Type 2 inflammation with late onset eosinophilic asthma (LOA) and chronic rhinosinusitis with nasal polyps (CRSwNP) are of non-allergic ethiology. For late onset type2 asthma, many risk factors have been defined, but clear insights into disease ethiology are currently lacking. Given the quintessential role of IgE in disease ethiology of both diseases, understanding the molecular immunological mechanisms underlying mucosal IgE responses is essential to understand disease ethiology. Hypothesis: Distinct mechanisms drive local IgE production in AA and LOA Overall objectives: Elucidate the potential drivers of and immunological pathways leading to local IgE production in AA and LOA, and understand how dupilumab acts on these mechanisms. Methods: A unique combination of state-of-the-art methods will be applied, including single-cell RNA sequencing and receptor profiling, proteomics, determination of the microbial composition, recombinant antibody screening and disease modelling in cell cultures. Expected results: The investigators expect for the first time to discern the drivers of local IgE production in LOA and uncover the immunological pathways leading to local IgE production in AA and LOA. Moreover, the investigators will obtain insights into the role of Dupilumab in modulation mechanisms. Impact: If successful, these insights will answer a long standing, unresolved question in type 2 disease and might aid in the development of novel directed therapeutics for AA and LOA.
Eligibility Criteria
Inclusion Criteria: patients with nasal polyposis - Exclusion Criteria: patients treated in the last 2 months with systemic corticosteroids \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06234761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pathophysiology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06234761 currently recruiting?
Yes, NCT06234761 is actively recruiting participants. Contact the research team at philippe.gevaert@ugent.be for enrollment information.
Where is the NCT06234761 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06234761 clinical trial?
NCT06234761 is sponsored by University Hospital, Ghent. The trial plans to enroll 50 participants.