Overview
Sponsor-declared trial summary
chronic rhinosinusitis with nasal polyps
This study aims to determine the effect of dupilumab on ear symptoms and auditory function in chronic rhinosinusitis with nasal polyp and eosinophilic otitis media patients
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- 11 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-19
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Sanofi
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
This study aims to determine the effect of dupilumab on ear symptoms and auditory function in chronic rhinosinusitis with nasal polyp and eosinophilic otitis media patients
Secondary objectives 2
- To determine the effect of dupilumab treatment on auditory function in CRSwNP+EOM patients at baseline and 6 or 12 months of treatment
- To determine the speed of changes in ear symptoms in CRSwNP+EOM patients treated with dupilumab, based on questionnaires and otoscopy at baseline, and 1, 3, 6 and 12 months of treatment
Conditions and MedDRA coding
chronic rhinosinusitis with nasal polyps
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Retrospective part: - CRSwNP+EOM patients having started dupilumab treatment from 2020 onwards with sufficient data to meet the primary endpoint (otologic questionnaires [OQUA and DCES] at baseline and at least at 6 or 12 months of treatment)
- Prospective part: adult (18 years and above) CRSwNP+EOM patients starting dupilumab treatment as part of regular clinical care
Exclusion criteria 4
- Prospective part: not being capable of filling in study questionnaires
- Prospective part: not being able to undergo audiometry
- Prospective part: <18 years of age
- Retrospective part: no consent to use the clinical data
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change of questionnaire scores between baseline and 6 or 12 months of treatment in CRSwNP+EOM patients
Secondary endpoints 3
- Change of audiometry outcomes between baseline and 6 or 12 months of treatment
- Change of questionnaire scores between baseline and 1, 3, 6 and 12 months of treatment
- Change of otoscopic findings between baseline and 1, 3, 6 and 12 months of treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dupixent 300 mg solution for injection in pre-filled pen
PRD9828015 · Product
- Active substance
- Dupilumab
- Substance synonyms
- REGN668, SAR231893
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- D11AH05 — -
- Marketing authorisation
- EU/1/17/1229/028
- 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
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- Sietze Reitsma
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Sietze Reitsma
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-09-11 | 2024-09-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-09 | Netherlands | Acceptable 2024-08-05
|
2024-08-19 |