Mepolizumab for Chronic rhinosinusitis with nasal polyps

Inclusion criteria

• {"criterion_text":"- ≥18 years of age.\n- Currently receiving treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) every four weeks.\n- Having received the biologic at unchanged dosing interval for at least three months.\n- For at least 1 year during treatment with biologics, the patients’ CRSwNP must be categorized as either \"controlled\" as defined by presence of none of the following 7 items, or as “partly controlled” as defined by presence of 1-2 of the following 7 items: 1) Nasal blockage: present on most days of the week 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week 3) Facial pain/pressure: present on most days of the week 4) Sense of smell: impaired 5) Sleep disturbance or fatigue: present 6) Nasal endoscopy: diseased mucosa 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment."}

Exclusion criteria

• {"criterion_text":"- Patients with no or limited response to biologics (“uncontrolled” in EPOS table in the protocol)\n- Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial\n- Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires\n- Patients who currently receive biologics for any other disease (asthma not included)\n- Patients who are not able to give informed consent (i.e., patients who are permanently incapable)\n- Patients who are not eligible because of the investigator’s judgement\n- Patients who experience pregnancy during the study will be excluded after an unscheduled visit – active IVF treatment (please see the protocol)\n- Unwillingness to follow the study procedure"}

Primary endpoints

• {"endpoint_text":"- In \"controlled\" patients presence of 0 & in \"partly controlled\" patients max. 2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment","definition_or_measurement_approach":"Disease control status evaluated using the defined 7-item EPOS-based criteria; primary outcome assessed by comparison of disease control assessments at baseline (week 0) and week 52 to determine percentage of patients achieving at least sustained degree of disease control."}

Secondary endpoints

• {"endpoint_text":"- 1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment.","definition_or_measurement_approach":"Changes measured from baseline to 52 weeks using SNOT-22, ACQ and smell test scores; disease control assessments compared by drug over same interval; baseline and demographic data collected per protocol."}

Denmark

Earliest CTIS Part Ii Submission Date

11-04-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

215

Number Of Sites

9

Number Of Participants

135

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"code:1","organisation_type":"Hospital/Clinic/Other health care facility"}