Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

Last updated: September 18, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

increased dosing interval of biological therapy

Clinical Study ID

NCT07187583
2024-519758-35-01
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 becategorized as "partly controlled" as defined by presence of 1-2 of the followingseven 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 courseof rescue treatment

of which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.

Exclusion

Exclusion Criteria:

  • Patients with excellent response to biologics (0 of the above-mentioned 7 items forpartly controlled disease)

  • Patients with no or limited response to biologics (>2 of the above-mentioned 7 itemsfor partly controlled disease)

  • Patients with a cancer diagnosis deemed by the investigator to precludeparticipation in the trial

  • Patients who, because of language barriers, are not able to understand Danishwritten 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 arepermanently incapable)

  • Patients who are not eligible because of the investigator's judgement

  • Patients who experience pregnancy during the study will be excluded after anunscheduled visit - active IVF treatment (please see below)

  • Unwillingness to follow the study procedure

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: increased dosing interval of biological therapy
Phase: 4
Study Start date:
June 05, 2025
Estimated Completion Date:
March 01, 2028

Study Description

This is an investigator-initiated, independent, national multicenter study with a real-world design and Good Clinical Practice (GCP) monitoring. The study is a randomized controlled drug trial investigating the non-inferiority of extended dosing intervals compared with standard treatment for patients with CRSwNP receiving mepolizumab (100 mg) or dupilumab (300 mg) every 4 weeks. Approximately 135 patients will be enrolled from ear, nose and throat departments in all five regions of Denmark. The study duration is approximately 2.5 years, with each patient followed for 52 weeks.

Randomization At inclusion, patients are randomized 1:1 to the intervention or control group. Randomization is computer-based (REDCap).

Control group Continues dosing of mepolizumab or dupilumab every 4 weeks.

Intervention group Increases to a 6-week dosing interval at baseline, and if response to the biological therapy is maintained, increases to 8-week dosing intervals at the follow-up visit at week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52. In case of worsening of CRSwNP-related symptoms, the patient reverts to the last effective dosing interval.

Clinical visits Clinical follow-ups are conducted at weeks 0, 12, 26, 38, and 52. The visits at weeks 0, 26, and 52 are already planned as a standard part of biological treatment outside the protocol and include endoscopic rhinoscopy, smell testing, and questionnaires: Sinonasal Outcome Test 22 (SNOT-22), Work Productivity and Activity Impairment (WPAI), and Asthma Control Questionnaire (ACQ). The visits at weeks 12 and 38 are study-specific and include patient-reported symptom severity on a Visual Analogue Scale (VAS), endoscopic rhinoscopy, and completion of questionnaires (SNOT-22, WPAI).

Connect with a study center

  • Dept of otorhinolaryngology, Aalborg University Hospital

    Aalborg 2624886, 9000
    Denmark

    Site Not Available

  • Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital

    Aarhus 2624652, 8200
    Denmark

    Site Not Available

  • Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • Esbjerg Og Grindsted Sygehus

    Esbjerg 2622447, 6700
    Denmark

    Site Not Available

  • Dept of otorhinolaryngology, Gødstrup Regional Hospital

    Herning 2620425, 7400
    Denmark

    Site Not Available

  • Dept of otorhinolaryngology, Nordsjaellands Hospital

    Hillerød 2620320, 3400
    Denmark

    Active - Recruiting

  • Dept of otorhinolaryngology, Sjællands Universitetshospital

    Køge 2618415, 4600
    Denmark

    Active - Recruiting

  • Dept of otorhinolaryngology, Odense University Hospital

    Odense 2615876, 5000
    Denmark

    Site Not Available

  • Dept of otorhinolaryngology, Lillebaelt Hospital

    Vejle 2610613, 7100
    Denmark

    Site Not Available

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