Dupilumab for Chronic rhinosinusitis with nasal polyps

Inclusion criteria

• {"criterion_text":"- Inclusion criteria: At the time when the patient started biological treatment, they must have fulfilled the EPOS criteria for initiation of biologic treatment (REF EPOS):\n- Fulfil the criteria for CRSwNP\n- Presence of bilateral polyps in a patient \n- Had ESS (sinus surgery) (exceptional circumstances excluded)\n- Fulfil at least three of the following five criteria: \tEvidence of type 2 inflammation \tNeed for (and treated with) systemic corticosteroids or contraindication to these \tSNOT-22 score of 40 or above \tSignificant loss of smell \tAsthma needing regular inhaled corticosteroids\n- To enter this study, the patient must be \n- Above 18 years of age\n- Currently be in treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) with treatment every fourth week. This treatment should have been stable/unchanged for at least three months.\n- Within the latest year the patient must at all times have assessed the control of the CRS as controlled (from the following three categories: controlled, partly controlled, uncontrolled) REF EPOS\n- Within the latest year the patient must at all times have scored the symptoms of CRS five or below on a VAS scale from 0 – 10 (This includes nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance or fatigue) (REF EPOS)\n- Within the latest year the nasal endoscopy cannot have showed polyp score of more than 1+1 out of 4+4, further, now thick secretions or general oedema must have been present.\n- Within the latest year the patient is not allowed to have had ESS or rescue treatment for their CRSwNP (antibiotics or systemic steroids)\n- The patient must be able to understand Danish and able to sign an informed content."}

Exclusion criteria

• {"criterion_text":"- Exclusion criteria\n- In the twelve months of remission the patient is not allowed to have had AECRS (acute exacerbation of chronic rhinosinusitis). A common cold is allowed.\n- Patients who, because of language barriers, are not able to understand 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 (LOCF) – active IVF treatment. (please look belove)\n- Malign disease within the last 5 years\n- Unwillingness to follow the study procedure"}

Primary endpoints

• {"endpoint_text":"- What percentage of patients can stop the biologic treatment and still be in complete remission","definition_or_measurement_approach":"Proportion (percentage) of patients who remain in complete remission after stopping biologic treatment; participants in both arms are followed for 12 months."}

Secondary endpoints

• {"endpoint_text":"- Is there any differences in what drug the patients have been treated with","definition_or_measurement_approach":"Comparison between the two treatments (Dupilumab vs Mepolizumab) in relation to achieving complete remission (assessed during follow-up; study aims to determine if one drug is better than the other)."}

Denmark

Earliest CTIS Part Ii Submission Date

06-02-2025

Latest Decision Or Authorization Date

09-02-2025

Processing Time Days

3

Number Of Sites

6

Number Of Participants

66

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":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}