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Biomarkers for the prediction of individual CRSwNP patients' responses to mepolizumab
EU CTIS ID: 2023-508069-34-01
What this study is testing
1. Identification of easily measurable biomarkers predicting individual patient’s response to mepolizumab 2. Correlation of patient-derived cell responses to mepolizumab with individual clinical responses to mepolizumab in ex vivo mucosal immunity model 3. Characterization of immune mechanisms behind immune responses of CRSwNP patients to mepolizumab 4. Characterization of immune mechanisms behind immune cell responses derived from CRSsNP patients to mepolizumab in ex vivo model
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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
- For healthy control group: ≥18 years of age AND Good general health AND No abnormalities in nasal endoscopy
You likely can't join if
- 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
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.