Reducing how often biologic injections are given for chronic nasal polyps

Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

This study will test whether spacing out mepolizumab or dupilumab injections to every 6–8 weeks keeps symptoms controlled in adults with partly controlled chronic rhinosinusitis with nasal polyps.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (Academic / other)
• Drugs / interventions: dupilumab, mepolizumab
• Locations: 9 sites (Aalborg and 8 other locations)
• Trial ID: NCT07187583 on ClinicalTrials.gov

What this trial studies

This is a national, investigator‑initiated, randomized, open‑label phase 4 non‑inferiority trial comparing extended dosing intervals with standard 4‑week dosing in adults with CRSwNP treated with mepolizumab 100 mg or dupilumab 300 mg. About 135 patients across Danish ENT centers will be randomized 1:1 to continue 4‑weekly dosing or to increase to 6 weeks at baseline and to 8 weeks at week 26 if control is maintained, with reversion to the last effective interval if symptoms worsen. Clinical follow‑ups including endoscopic rhinoscopy, smell testing, and symptom questionnaires occur at weeks 0, 12, 26, 38, and 52, and the trial is monitored under Good Clinical Practice. Randomization is computer‑based (REDCap) and the design aims to reflect real‑world clinical practice.

Who should consider this trial

Good fit: Adults (≥18) currently receiving mepolizumab 100 mg or dupilumab 300 mg every four weeks for at least three months whose CRSwNP has been 'partly controlled' for at least one year per protocol criteria are ideal candidates.

Not a fit: Patients with an excellent response to biologics, those with unstable or worsening CRSwNP, or those unable to attend regular in-person follow‑up are unlikely to receive benefit from tapering.

Why it matters

Potential benefit: If successful, patients may maintain symptom control with fewer injections, reducing clinic visits, treatment burden, and potentially costs.

How similar studies have performed: Tapering biologic therapies has shown mixed but promising results in asthma and other eosinophilic diseases, while randomized evidence specifically in CRSwNP is limited.

Eligibility criteria

Inclusion Criteria:

* ≥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):

  1. Nasal blockage: present on most days of the week
  2. Rhinorrhoea/postnasal drip: mucopurulent on most days of the week
  3. Facial pain/pressure: present on most days of the week
  4. Sense of smell: impaired
  5. Sleep disturbance or fatigue: present
  6. Nasal endoscopy: diseased mucosa
  7. 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.

Exclusion Criteria:

* 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 this trial is running

Aalborg and 8 other locations

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

Study contacts

• Study coordinator: Elizabeth M. Stevens Saporito, MD

Conditions Chronic Rhinosinusitis With Nasal Polyps