Overview
Sponsor-declared trial summary
non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD)
The main goal of this study is to assess the long-term effect of Dupilumab on patients with N-ERD with a special focus on the long-term effects of Dupilumab on salicylic acid tolerance. We hope to find higher rates of salicylic acid tolerant patients compared to before treatment and 6 months after treatment initiation.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2025-05-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main goal of this study is to assess the long-term effect of Dupilumab on patients with N-ERD with a special focus on the long-term effects of Dupilumab on salicylic acid tolerance. We hope to find higher rates of salicylic acid tolerant patients compared to before treatment and 6 months after treatment initiation.
Conditions and MedDRA coding
non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD)
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-520082-31-00 | Long-term effect of Dupilumab on acetylsalicylic acid (ASA) intolerance and its mechanisms in patients with non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD) | Medical University Of Vienna |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Participated previously in a previous study (EK 1044/2020) 2. Signed and dated informed consent has been obtained 3. Current therapy with Dupilumab
Exclusion criteria 1
- 1. Pregnancy (as determined by urine ß-HCG test) 2. Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C) 3. History of malignancy or immunodeficiency 4. Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis) 5. Need for systemic corticosteroid therapy 1 month prior to screening visit 6. Eosinophilic pneumonia and Churg-Strauss Syndrome
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 1. Serum ECP, total IgE, allergen specific IgE, tryptase, peripheral blood eosinophils 2. Allergenic sensitization as assessed by skin prick and blood test 3. Olfactory performance 4. Prostaglandin levels in urine 5. Cytokine pattern in nasal secretions 6. Inflammatory cytokine patterns at mRNA levels 7. Nasal microbiome composition 8. TPS, VAS, SNOT-22 9. ACT, ACQ
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dupixent 300 mg solution for injection in pre-filled syringe
PRD5521296 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/005
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Ear, Nose and Throat Diseases, Division of General Otorhinolaryngology
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Ear, Nose and Throat Diseases, Division of General Otorhinolaryngology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_N-ERD_for_publication | 2.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_V1_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_V2_EN | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_redacted | 1 |
| Recruitment arrangements (for publication) | KI_Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_marked | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dupilumab_EN | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_N-ERD | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_N-ERD | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-04 | Austria | Acceptable 2025-05-02
|
2025-05-20 |