Early access
Sign in
Taking peoplePhase 4

Stopping mepolizumab or dupilumab in people with nasal polyps whose disease is controlled

Tests stopping mepolizumab or dupilumab in adults with controlled nasal polyps.

Key facts

Who runs it
Copenhagen University Hospital, Rigshospitalet
Where
Denmark6 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Complete Remission After Treatment With Biologics for Nasal Polyps
Status
Recruiting
Phase
Phase 4
People taking part
66 people, planned
Started
3 Apr 2025
Expected to end
1 Jun 2027
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • DUPIXENT®
  • NUCALA®
  • Dupi discontinuation
  • Mepo discontinuation
Record updated
5 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe chronic rhinosinusitis with nasal polyps whose disease has been controlled for a year on Dupilumab or Mepolizumab. People are split by chance to stop or continue the drug.

Age
Above 18 years of age
Sex
All sexes can join
Disease stage
Severe chronic rhinosinusitis with polyps on both sides of the nose, under control for the latest year. All symptom scores must have stayed 5 or below on a 0 - 10 scale. Polyp score must not have been more than 1+1 out of 4+4.
Earlier treatment
At the start of biologic treatment, people must have met the EPOS criteria and had sinus surgery (ESS), except in exceptional circumstances. They must now get Dupilumab (300 mg) or Mepolizumab (100 mg) every fourth week, unchanged for at least three months. No sinus surgery, antibiotics or systemic steroids for the polyps in the latest year.
Biomarker or test result
At the start of biologic treatment, at least three of five criteria were needed. One of them was evidence of type 2 inflammation.

Main reasons for not taking part

  • A sudden worsening of chronic rhinosinusitis in the twelve months of remission (a common cold is allowed)
  • Polyp removal in the clinic within the last 3 months
  • Asthma not under control (ACQ score higher than 1.2 at any time in the twelve months)
  • Taking biologics for another disease (asthma not included)
  • Pregnancy, active IVF treatment, or allergy to Dupilumab or Mepolizumab

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 5.1 Inclusion criteria (all must be fulfilled)
  • 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

Who cannot take part

  • Patients who currently receive biologics for any other disease (asthma not included)
  • 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
  • Hypersensitivity to any of either Dupilumab or Mepolizumab
  • 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 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)
  • Unwillingness to follow the study procedure

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Arm 1: Continue Drug DExisting treatment, for comparison

    Participants continue their usual treatment with Drug Dupi throughout the study.

    Treatment: DUPIXENT®

  • Arm 2: Stop Drug DTreatment being tested

    Participants discontinue Drug Dupi at baseline and receive no active treatment during the study.

    Treatment: Dupi discontinuation

  • Arm 3: Continue Drug MExisting treatment, for comparison

    Participants continue their usual treatment with Drug Mepo throughout the study.

    Treatment: NUCALA®

  • Arm 4: Stop Drug MTreatment being tested

    Participants discontinue Drug Mepo at baseline and receive no active treatment during the study.

    Treatment: Mepo discontinuation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
English Title: Complete Remission Study Subtitle: Discontinuation of Mepolizumab or Dupilumab After at Least 12 Months Without Symptoms in Patients With Severe Chronic Rhinosinusitis With Polyps - a National Danish RCT Study
Plain-language title
Stopping mepolizumab or dupilumab in people with nasal polyps whose disease is controlledGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
5 December 2025