Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

Recruiting now · Phase 4

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps

In brief

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).

Key facts

Study ID

NCT07187583

Run by

Rigshospitalet, Denmark

People needed

135

Starts

2025-06-05

Expected to finish

2028-03-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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, 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 below)
• Unwillingness to follow the study procedure

Where it is running

• Dept of otorhinolaryngology, Sjællands Universitetshospital — Køge, Denmark (enrolling)
• Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet — Copenhagen, Denmark (enrolling)
• Dept of otorhinolaryngology, Nordsjaellands Hospital — Hillerød, Denmark (enrolling)
• Dept of otorhinolaryngology, Gødstrup Regional Hospital — Herning, Denmark
• Dept of otorhinolaryngology, Odense University Hospital — Odense, Denmark
• Dept of otorhinolaryngology, Aalborg University Hospital — Aalborg, Denmark
• Dept of otorhinolaryngology, Lillebaelt Hospital — Vejle, Denmark
• Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital — Aarhus, Denmark
• Esbjerg Og Grindsted Sygehus — Esbjerg, Denmark

Full record on ClinicalTrials.gov

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