Spacing out biologic treatment doses in chronic rhinosinusitis with nasal polyps
Tests longer gaps between biologic doses in adults with chronic rhinosinusitis with nasal polyps.
Key facts
- Who runs it
- Copenhagen University Hospital, Rigshospitalet
- Where
- Denmark9 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 135 people, planned
- Started
- 5 Jun 2025
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- increased dosing interval of biological therapy
- Record updated
- 23 September 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 13 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 one year during treatment with biologics, the patients' CRSwNP must be categorized as "partly controlled" as defined by presence of 1-2 of the following seven items (also available in EPOS 2020 table in protocol):; Nasal blockage: present on most days of the week; Rhinorrhoea/postnasal drip: mucopurulent on most days of the week; Facial pain/pressure: present on most days of the week; Sense of smell: impaired; Sleep disturbance or fatigue: present; Nasal endoscopy: diseased mucosa; Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment; of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5
Who cannot take part
- Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease)
- Patients with no or limited response to biologics (>2 of the above-mentioned 7 items for partly controlled disease)
- Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial
- Patients who currently receive biologics for any other disease (asthma not included)
- Patients who, because of language barriers, are not able to understand Danish 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 - active IVF treatment (please see below)
- 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 purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).
The 2 groups in the trial
- Standard dosing of biological therapyNo study treatment, for comparison
Continues dosing of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) every 4 weeks.
- Increased dosing interval of biological therapyExisting treatment, for comparison
Increases to a 6-week dosing interval at baseline - of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) - and if response to therapy is maintained, increases to 8-week dosing intervals at the follow-up visit in week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps
- Plain-language title
- Spacing out biologic treatment doses in chronic rhinosinusitis with nasal polypsGenerated from the registry record. The registry title is the official one.
- Record updated
- 23 September 2025