Tapering of biologics in chronic rhinosinusitis with nasal polyps
Key facts
- Who runs it
- Rigshospitalet
- Where
- Denmark9 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 4
- People taking part
- 135 people, planned
- Started
- 27 May 2025
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional
- Record updated
- 12 November 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- ≥18 years of age. • Currently receiving treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) every four weeks. • Having received the biologic at unchanged dosing interval for at least three months. • 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 (see EPOS 2020 table in protocol): 1. Nasal blockage: present on most days of the week 2. Rhinorrhoea/postnasal drip: mucopurulent on most days of the week 3. Facial pain/pressure1: present on most days of the week 4. Sense of smell: impaired 5. Sleep disturbance or fatigue1: present 6. Nasal endoscopy: diseased mucosa 7. Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
Who cannot take part
- Patients with no or limited response to biologics (“uncontrolled” in EPOS table in the protocol) • Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial • Patients who, because of language barriers, are not able to understand Danish 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 – active IVF treatment (please see the protocol) • 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
The objective is to evaluate the impact of prolonged dosing intervals of biologic therapy in patients with CRSwNP who have demonstrated stable, completely or partly controlled disease. Specifically, the study will assess at least continued degree of disease control after 52 weeks of prolonged dosing intervals in patients who have received treatment with Mepolizumab or Dupilumab for at least 18 months, with consistent completely or partly controlled disease for a minimum of 12 months. The primary outcome is to find the percentage of patients achieving at least sustained degree of disease controll after tapering of biologics for CRSwNP. This will be evaluated by comparison of disease control assessments at weeks 0 and 52.
Data and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- English Title: Tapering of biologics in CRSwNP Subtitle: Tapering of Mepolizumab or Dupilumab after 12 months of complete or partial disease control in patients with severe chronic rhinosinusitis with nasal polyposis – a national Danish RCT.
- Record updated
- 12 November 2025