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Clinical Trials in Denmark / NCT07268313
Recruiting Phase 4

Complete Remission After Treatment With Biologics for Nasal Polyps

NCT07268313 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 4
Started
2025-04-03
Last updated
2025-12-05

Condition(s) studied

Nasal Polyps

Investigational drug(s) / intervention(s)

DUPIXENT® →NUCALA® →Dupi discontinuationMepo discontinuation

DUPIXENT®: Continue Dupixent

NUCALA®: "Continue Nucala

Dupi discontinuation: Stop taking Dupixent at baseline; no substitute is given

Mepo discontinuation: Stop taking Nucala at baseline; no substitute is given

Study summary

In this RCT the investigators randomize patients who are treated with biologic treatment (Nucala or Dupixent) due to nasal polyps and have controlled disease within the last year to either stop treatment og continue as a control group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 5.1 Inclusion criteria (all must be fulfilled) 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): * Fulfil the criteria for CRSwNP * Presence of bilateral polyps in a patient * Had ESS (sinus surgery) (exceptional circumstances excluded) * Fulfil at least three of the following five criteria Evidence of type 2 inflammation Need for (and treated with) systemic corticosteroids or contraindication to these SNOT-22 score of 40 or above Significant loss of smell Asthma needing regular inhaled corticosteroids To enter this study, the patient must be: * Above 18 years of age * 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. * Within the latest year, the patient must at all times have scored all the below symptoms of CRS five or below on a VAS scale from 0 - 10 - Doing this, it is according to the EPOS defined as controlled disease. The items are: nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance or fatigue) Please view appendix 2. * Within the latest year the nasal endoscopy cannot have showed polyp score of more than 1+1 out of 4+4, further, no thick secretions or general oedema must have been present. * Within the latest year the patient is not allowed to have had ESS or rescue treatment for their CRSwNP (antibiotics or systemic steroids) * The patient must be able to understand Danish and able to sign an informed content. Exclusion Criteria: * 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. * Polyp removal in the out-patient clinic may not have been performed within the last 3 months. * In the twelve months of remission the patient cannot at any time have scored higher than 1.2 on the ACQ questionnaire, meaning that the patient does not have uncontrolled asthma (Appendix 3). * Patients who, because of language barriers, are not able to understand written information and, thus, are not able to answer questionnaires. * Patients who currently receive biologics for any other disease (asthma not included) * Patients who are not able to give informed consent (i.e., patients who are permanently incapable) * Patients who are not eligible because of the investigator's judgement * Patients who experience pregnancy during the study will be excluded after an unscheduled visit (LOCF) - active IVF treatment. (Please look belove) * Patients who have or recently have had illness, such as cancer that or its treatment is expected to significantly affect morbidity and/or quality of life in the next two years * Unwillingness to follow the study procedure * Hypersensitivity to any of either Dupilumab or Mepolizumab.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Region H Recruiting
Nordsjællands hospital Hillerød Region H Recruiting
Køge øre næse hals afd Køge Region Sj Recruiting
Dept. of otorhinolaryngology, Odense Odense Region Syd Recruiting
Vejle sygehus Vejle Region S Recruiting
Gødstrup Hospital Gødstrup Denmark Recruiting

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07268313 on ClinicalTrials.gov ↗ ← All trials in Denmark