Clinical trial • Not applicable • Immunology

DUPILUMAB for Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD)

Not applicable trial of DUPILUMAB for Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD).

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD)
Trial Stage
Not applicable
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
04-02-2025
First CTIS Authorization Date
20-05-2025

Trial design

open-label, none/not specified-controlled Not applicable trial across 1 site in Austria.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
30

Eligibility

Recruits 30 No vulnerable populations selected. Signed and dated informed consent is required from participants. No assent process for minors or special consent procedures for vulnerable groups described in the available documents..

Pregnancy Exclusion
Pregnancy (as determined by urine ß-HCG test)
Vulnerable Population
No vulnerable populations selected. Signed and dated informed consent is required from participants. No assent process for minors or special consent procedures for vulnerable groups described in the available documents.

Inclusion criteria

  • {"criterion_text":"- 1. Participated previously in a previous study (EK 1044/2020)\n- 2. Signed and dated informed consent has been obtained\n- 3. Current therapy with Dupilumab"}

Exclusion criteria

  • {"criterion_text":"- 1. Pregnancy (as determined by urine ß-HCG test)\n- 2. Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C)\n- 3. History of malignancy or immunodeficiency\n- 4. Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis)\n- 5. Need for systemic corticosteroid therapy 1 month prior to screening visit\n- 6. Eosinophilic pneumonia and Churg-Strauss Syndrome"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Tolerated aspirin dose levels as tested with different dosages (62.5mg, 125mg, 250mg and 500 mg) compared to tolerated dosages before and 6 months into Dupilumab treatment.","definition_or_measurement_approach":"Aspirin challenge testing at incremental dosages (62.5 mg, 125 mg, 250 mg, 500 mg) comparing the tolerated dose to baseline (before Dupilumab) and at 6 months after Dupilumab initiation."}

Secondary endpoints

  • {"endpoint_text":"- 1. Serum ECP, total IgE, allergen specific IgE, tryptase, peripheral blood eosinophils\n- 2. Allergenic sensitization as assessed by skin prick and blood test\n- 3. Olfactory performance\n- 4. Prostaglandin levels in urine\n- 5. Cytokine pattern in nasal secretions\n- 6. Inflammatory cytokine patterns at mRNA levels\n- 7. Nasal microbiome composition\n- 8. TPS, VAS, SNOT-22\n- 9. ACT, ACQ","definition_or_measurement_approach":"Measured by serum assays for ECP, total and specific IgE, tryptase and peripheral eosinophils; skin prick testing and blood tests for sensitization; standardized olfactory testing for olfactory performance; urine assays for prostaglandin levels; cytokine assays in nasal secretions and mRNA analysis for inflammatory cytokine patterns; nasal microbiome analysis (sequencing); validated symptom and quality-of-life instruments TPS, VAS, SNOT-22; and asthma control questionnaires ACT and ACQ."}

Recruitment

Planned Sample Size
30
Recruitment Window Months
12
Consent Approach
Signed and dated informed consent is required from participants. Subject information and informed consent forms are listed among the trial documents, with patient-facing documents available in English and German. No assent process for minors or separate age-specific consent procedures are described in the available records.

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Austria

Earliest CTIS Part Ii Submission Date
01-05-2025
Latest Decision Or Authorization Date
20-05-2025
Processing Time Days
19
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Ear, Nose and Throat Diseases, Division of General Otorhinolaryngology
Principal Investigator Name
Sven Schneider
Principal Investigator Email
Sven.schneider@meduniwien.ac.at
Contact Person Name
Sven Schneider
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Medical University Of Vienna
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
Dupixent 300 mg solution for injection in pre-filled syringe
Active Substance
DUPILUMAB
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous injection
Route
Subcutaneous injection
Authorisation Status
Authorised
Maximum Dose
300 mg

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