mepolizumab for Chronic rhinosinusitis with nasal polyps | Chronic rhinosinusitis without nasal polyps

Inclusion criteria

• {"criterion_text":"- For CRSwNP group: adult patients (≥18 years) with CRSwNP and fulfilling the EPOS2020 criteria for treatment with a biological who will be treated with mepolizumab\n- For CRSsNP group: ≥18 years of age AND ENT physician diagnosis of CRSsNP AND Ongoing symptoms for at least 8 weeks prior to study entry, including nasal congestion, blockage, or obstruction with moderate or severe symptom scores\n- For healthy control group: ≥18 years of age AND Good general health AND No abnormalities in nasal endoscopy"}

Exclusion criteria

• {"criterion_text":"- For CRSwNP group: age ≤ 17 years OR previous participation in mepolizumab (and/or anti IL-5 treatment) study OR a patient is not able to complete the SNOT 22 questionnaire OR a strong indication for surgical treatment (e.g.: mucoceles) OR systemic diseases affecting the nose (e.g.: GPA, EGPA, sarcoid, primary ciliary dyskinesia, cystic fibrosis) OR antrochoanal polyps (isolated benign polyps originating from the mucosa of the maxillary sinus with a distinctive small stalk) OR inverted papilloma and malignant polyps OR acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit OR use of systemic corticosteroids within 4 weeks before the inclusion visit OR need for continuous systemic corticosteroid treatment for another disease than CRSwNP OR systemic diseases preventing participation in the study (all comorbidities that have a higher impact on quality of life than CRSwNP and/or making the patient at risk during the study period) OR other systemic medical treatments influencing disease or primary and secondary study outcome measurements such as (non-)selective immunosuppressants (e.g.: azathioprine, methotrexate) and other monoclonal antibodies other than mepolizumab\n- For CRSsNP group: age ≤ 17 years OR previous participation in mepolizumab study OR systemic diseases affecting the nose (e.g.: GPA, EGPA, sarcoid, primary ciliary dyskinesia, cystic fibrosis) OR antrochoanal polyps (isolated benign polyps originating from the mucosa of the maxillary sinus with a distinctive small stalk) OR inverted papilloma and malignant polyps OR acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit OR use of systemic corticosteroids within 4 weeks before the inclusion visit OR need for continuous systemic corticosteroid treatment of systemic diseases preventing participation in the study OR other systemical medical treatments influencing disease or primary and secondary study outcome measurements such as (non-)selective immunosuppressants (e.g.: azathioprine, methotrexate) and other monoclonal antibodies\n- For healthy control group: age ≤ 17 years OR previous participation in mepolizumab study OR nasal surgery at least six months prior to the study visit OR presence of any (chronic) or acute pathologies of the upper and lower airways at least six weeks prior to the inclusion OR need for any medications at least three weeks prior to the inclusion OR other systemical medical treatments influencing disease or primary and secondary study outcome measurements such as (non-)selective and other monoclonal antibodies"}

Primary endpoints

• {"endpoint_text":"- Identification of cell/molecular biomarkers correlated with individual patients’ responses. These could be: frequencies of cell (sub)populations, gene expression pattern, cell activation statues/phenotype, expression/production pattern of cell products","definition_or_measurement_approach":"Identification of cell/molecular biomarkers correlated with individual patients’ responses; examples listed include frequencies of cell (sub)populations, gene expression patterns, cell activation status/phenotype, expression/production pattern of cell products"}
• {"endpoint_text":"- Identification of immunological mechanisms behind responses to mepolizumab","definition_or_measurement_approach":"Not specified beyond the endpoint title"}
• {"endpoint_text":"- Evidence for the effectiveness in in vitro setting of mepolizumab in certain CRSsNP patients / endotypes","definition_or_measurement_approach":"Assessment of mepolizumab effectiveness in in vitro (ex vivo mucosal immunity) models; exact assays not detailed"}

Secondary endpoints

• {"endpoint_text":"- For CRSwNP group: Change in SNOT-22 from baseline to 6 months post-treatment","definition_or_measurement_approach":"Change in SNOT-22 score from baseline to 6 months post-treatment"}

Netherlands

Earliest CTIS Part Ii Submission Date

06-05-2024

Latest Decision Or Authorization Date

03-06-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

70

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"GlaxoSmithKline","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"GLAXOSMITHKLINE TRADING SERVICES LIMITED","duties_or_roles":"Listed as product organisation in product dictionary","organisation_type":""}