Overview
Sponsor-declared trial summary
Eosinophilic Granulomatosis with Polyangiitis (eGPA)
In eGPA patients treatment with mepolizumab restores changes of the nasal microbiome healthy control phenotype
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 13 Feb 2024 → ongoing
- Decision date (initial)
- 2024-02-02
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
In eGPA patients treatment with mepolizumab restores changes of the nasal microbiome healthy control phenotype
Conditions and MedDRA coding
Eosinophilic Granulomatosis with Polyangiitis (eGPA)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- >18 years of age
- Able to give informed consent
- In CRSwNP group: availability of bilateral nasal polyps as diagnosed by endoscopy or CT scan
- In Severe asthma group: clinical diagnosis of asthma with FEV1 <80% AND either FEV1 reversibility >12% initial or documented positive metacholine challenge (PC20 < 8 mg/ml)
- In eGPA group: Fulfilling the 2022 ACR/EULAR criteria for eGPA (Wechsler et al., 2017)
- In GPA group: fulfilling the ACR/EULAR GPA criteria (Robson et al., 2022)
- In healthy controls: absence of asthma symptoms, no bronchial hyperresponsiveness
Exclusion criteria 8
- Unable to give informed consent
- Active smoking < (less than) 6 months from baseline visit
- Pregnant or breastfeeding woman
- In CRSwNP group: current use of asthma medication, eGPA
- In healthy controls: chronic use of local anti-inflammtory agents
- In healthy controls: use of immunosuppressive medication
- In healthy controls: use of antibiotics within the last month (before start study/screening/)
- concomitant use of dupilumab within 6 months of baseline visit
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The effect mepolizumab treatment has on the nasal microbiome profiles after three months of treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB21650 · Substance
- Active substance
- Mepolizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 36 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Bram Rutgers
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Bram Rutgers
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 150 | 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 | 2024-02-13 | 2024-02-13 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-02 | Netherlands | Acceptable 2024-02-02
|
2024-02-02 |