Overview
Sponsor-declared trial summary
Chronic rhinosinusitis with nasal polyps
To evaluate the effect of secukinumab 150mg in reducing SNOT-22 and NPS scores for patients with CRSwNP) in treating non-type 2 CRSwNP
Key facts
- Sponsor
- Tartu University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- 13 Aug 2023 → 23 Jan 2024
- Decision date (initial)
- 2023-08-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Tartu University Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Dose response
To evaluate the effect of secukinumab 150mg in reducing SNOT-22 and NPS scores for patients with CRSwNP) in treating non-type 2 CRSwNP
Secondary objectives 1
- • To evaluate the effect of secukinumab 150mg in reducing IL-17 associated inflammatory molecular markers in the nasal mucosa and peripheral blood
Conditions and MedDRA coding
Chronic rhinosinusitis with nasal polyps
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- CRSwNP diagnosed in accordance to EPOS2020 cirteria
- age between 18-64
- Previous treatment with glucocorticosteroids and/or surgery have yielded unacceptable disease control
- Non-responsive to IL-4/IL-13 antibody (dupilumab) treatment
Exclusion criteria 7
- Current malignant disease or remission time less than 24 months
- Current autoimmune disease or remission time less than 24 months
- Using immunosuppressive or biologic treatment less than 8 weeks prior to first study visit
- Pregnancy, breastfeeding
- Inflammatory bowel disease (Crohn’s disease, ulcerative colitis).
- Necessary to administer live vaccines during the treatment period
- clinically important, active infection, e.g. active or latent tuberculosis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- mean change of NPS and SNOT-22 scores from baseline to week 16
Secondary endpoints 1
- mean change from baseline to week 16 in IL-17 associated inflammatory markers
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cosentyx 150 mg solution for injection in pre-filled syringe
PRD2398835 · Product
- Active substance
- Secukinumab
- Substance synonyms
- Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 1050 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC10 — -
- Marketing authorisation
- EU/1/14/980/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tartu University Hospital
- Sponsor organisation
- Tartu University Hospital
- Address
- L. Puusepa Tn 1a
- City
- Tartu Linn
- Postcode
- 50406
- Country
- Estonia
Scientific contact point
- Organisation
- Tartu University Hospital
- Contact name
- Ear Clnic
Public contact point
- Organisation
- Tartu University Hospital
- Contact name
- Ear Clnic
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Estonia | Ended | 4 | 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 |
|---|---|---|---|---|---|
| Estonia | 2023-08-13 | 2024-01-23 | 2023-08-13 | 2023-09-07 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-17 | Estonia | Acceptable 2023-08-07
|
2023-08-11 |