Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps

NCT07187583 | Recruiting Phase 4 DMC

• 1 other identifier: 2024-519758-35-01
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• The percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP

  "partly controlled" as defined by presence of 1-2 of the following 7 items: 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

  from enrollment (week 0) to week 52.

Study Arms (2)

Standard dosing of biological therapy

NO INTERVENTION

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 therapy

ACTIVE COMPARATOR

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.

Drug: increased dosing interval of biological therapy

Interventions

increased dosing interval of biological therapy DRUG

Increasing dosing interval of biological therapy for CRSwNP from every 4 weeks to every 6 weeks and if continued satisfactory response then to every 8 weeks.

Increased dosing interval of biological therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (9)

Dept of otorhinolaryngology, Aalborg University Hospital

Aalborg, 9000, Denmark

NOT YET RECRUITING

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

Aarhus, 8200, Denmark

NOT YET RECRUITING

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

Copenhagen, 2100, Denmark

RECRUITING

Esbjerg Og Grindsted Sygehus

Esbjerg, 6700, Denmark

NOT YET RECRUITING

Dept of otorhinolaryngology, Gødstrup Regional Hospital

Herning, 7400, Denmark

NOT YET RECRUITING

Dept of otorhinolaryngology, Nordsjaellands Hospital

Hillerød, 3400, Denmark

RECRUITING

Dept of otorhinolaryngology, Sjællands Universitetshospital

Køge, 4600, Denmark

RECRUITING

Dept of otorhinolaryngology, Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Dept of otorhinolaryngology, Lillebaelt Hospital

Vejle, 7100, Denmark

NOT YET RECRUITING

Study Officials

• Christian von Buchwald, MD, DMSc, prof.

  Rigshospitalet, Dept. of Otorhinolaryngology, Head and Neck Surgery & Audiology

  STUDY DIRECTOR

Central Study Contacts

Elizabeth M. Stevens Saporito, MD

CONTACT

+4535452370; este0027@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: national coordinating investigator, and sub-investigator at Rigshospitalet

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 23, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

DK (9)