Treatment of non-type 2 CRSwNP with anti-IL-17 antibody (secukinumab)
Phase 1
Active, not recruiting
- Conditions
- Chronic rhinosinusitis with nasal polypsTherapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Registration Number
- CTIS2023-505711-20-00
- Lead Sponsor
- Tartu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 Objective: •To evaluate the effect of secukinumab 150mg in reducing IL-17 associated inflammatory molecular markers in the nasal mucosa and peripheral blood;Primary end point(s): mean change of NPS and SNOT-22 scores from baseline to week 16
- Secondary Outcome Measures
Name Time Method Secondary end point(s):mean change from baseline to week 16 in IL-17 associated inflammatory markers