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Tapering of biologics in chronic rhinosinusitis with nasal polyps
EU CTIS ID: 2024-519758-35-01
What this study is testing
The objective is to evaluate the impact of prolonged dosing intervals of biologic therapy in patients with CRSwNP who have demonstrated stable, completely or partly controlled disease. Specifically, the study will assess at least continued degree of disease control after 52 weeks of prolonged dosing intervals in patients who have received treatment with Mepolizumab or Dupilumab for at least 18 months, with consistent completely or partly controlled disease for a minimum of 12 months. The primary outcome is to find the percentage of patients achieving at least sustained degree of disease controll after tapering of biologics for CRSwNP. This will be evaluated by comparison of disease control assessments at weeks 0 and 52.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 1 year during treatment with biologics, the patients’ CRSwNP must be categorized as either "controlled" as defined by presence of none of the following 7 items, or as “partly controlled” as defined by presence of 1-2 of the following 7 items (see 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/pressure1: present on most days of the week 4. Sense of smell: impaired 5. Sleep disturbance or fatigue1: present 6. Nasal endoscopy: diseased mucosa 7. Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment.
You likely can't join if
- • Patients with no or limited response to biologics (“uncontrolled” in EPOS table in the protocol) • 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 the protocol) • Unwillingness to follow the study procedure
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.