Reducing how often biologic injections are given for chronic nasal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Dept of otorhinolaryngology, Nordsjaellands Hospital
  Hillerød, Denmark Recruiting
• Dept of otorhinolaryngology, Sjællands Universitetshospital
  Køge, Denmark Recruiting
• 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
• Esbjerg Og Grindsted Sygehus
  Esbjerg, Denmark Not yet recruiting

Study contacts

• Study coordinator: Elizabeth M. Stevens Saporito, MD
• Email: este0027@regionh.dk
• Phone: +4535452370

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps

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• Tezepelumab for Chinese adults with nasal polyps: a 24-week treatment study

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• Sinonasal microbiome transplant for chronic rhinosinusitis

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• SHR-1905 injection for chronic rhinosinusitis with nasal polyps

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• Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients

  This study is testing if the medication Dupilumab can improve the nasal barrier function in people with chronic rhinosinusitis, especially those with nasal polyps.

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• Understanding Basal Cell Function in Chronic Rhinosinusitis with Nasal Polyps

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.