Actively Recruiting
Complete Remission Study: Discontinuation of Mepolizumab or Dupilumab After at Least 12 Months Without Symptoms in Patients With Severe Chronic Rhinosinusitis With Polyps - a National Danish Randomized Controlled Trial
Led by Rigshospitalet, Denmark · Updated on 2025-12-05
66
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether patients with severe chronic rhinosinusitis with nasal polyps, who have been successfully treated with biologic therapies (Mepolizumab or Dupilumab) and have been symptom-free for at least a year, can safely stop their biologic treatment without the disease returning. This randomized controlled trial aims to find out how many patients remain in complete remission after stopping treatment and to compare if one of the two biologic drugs is more likely to maintain remission. The study follows Danish guidelines recommending trial cessation of biologics after two years of well-controlled disease. Participants are randomly assigned to one of two groups: one group continues their biologic treatment with either Dupilumab or Mepolizumab every four weeks, while the other group stops their biologic treatment completely at the start of the study. The study lasts for 52 weeks for each participant. If symptoms return or patients feel their disease is partly uncontrolled, those who stopped treatment will restart the same biologic at the previous dose and interval. The trial is open-label, meaning both participants and investigators know the treatment assignments. Throughout the study, participants will be monitored at baseline and at 12, 26, 38, and 52 weeks to assess if their nasal and sinus symptoms recur. Participants can also contact the research team anytime if symptoms reappear. The main outcome measured is the number of patients who remain in complete remission without biologic treatment after one year. Secondary outcomes include differences between the two biologics regarding remission maintenance. No additional tests or procedures beyond usual care are added, and safety monitoring is included to ensure quick intervention if needed.
CONDITIONS
Brief Title
Complete Remission After Treatment With Biologics for Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At the time of starting biologic treatment, patients must have met EPOS criteria for chronic rhinosinusitis with nasal polyps (CRSwNP)
- Presence of bilateral nasal polyps
- Had endoscopic sinus surgery (ESS), except in exceptional cases
- Fulfilled at least three of the following: evidence of type 2 inflammation; need for systemic corticosteroids or contraindication to them; SNOT-22 score of 40 or above; significant loss of smell; asthma requiring regular inhaled corticosteroids
- Age 18 years or older
- Currently treated with either Dupilumab 300 mg or Mepolizumab 100 mg every four weeks, with stable treatment for at least three months
- Controlled disease within the past year, scoring five or below on a 0-10 scale for nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell, sleep disturbance, or fatigue
- Nasal endoscopy within the past year showing polyp score of 1+1 or less, no thick secretions, or general edema
- No sinus surgery or rescue treatment (antibiotics or systemic steroids) in the past year
- Ability to understand Danish and provide informed consent
You will not qualify if you...
- Acute exacerbation of chronic rhinosinusitis (AECRS) during the past 12 months (common cold allowed)
- Polyp removal in outpatient clinic within the last 3 months
- Uncontrolled asthma with ACQ score higher than 1.2 in the past year
- Inability to understand written information due to language barriers or cognitive incapacity
- Use of biologics for other diseases (except asthma)
- Pregnancy or active IVF treatment during the study
- Recent or current illness such as cancer expected to affect health or quality of life in the next two years
- Unwillingness to follow the study procedures
- Hypersensitivity to Dupilumab or Mepolizumab
- Investigator judgment deeming a patient ineligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants are randomized to either continue their biologic treatment or stop it to observe if remission is maintained.
Visits at baseline and weeks 12, 26, 38, and 52; participants may contact investigators anytime if symptoms reoccur
Trial Site Locations
Total: 6 locations
1
Rigshospitalet
Copenhagen, Region H, Denmark, 2100
Actively Recruiting
2
Nordsjællands hospital
Hillerød, Region H, Denmark, 3400
Actively Recruiting
3
Køge øre næse hals afd
Køge, Region Sj, Denmark, 4600
Actively Recruiting
4
Dept. of otorhinolaryngology, Odense
Odense, Region Syd, Denmark, 5000
Actively Recruiting
5
Vejle sygehus
Vejle, Region S, Denmark, 7100
Actively Recruiting
6
Gødstrup Hospital
Gødstrup, Denmark
Actively Recruiting
Research Team
K
Kasper Aanæs, md, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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