NCT05942222Active, not recruitingPhase 4
A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients. The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of: * A subjective score (the SNOT-22) * An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8)) Methods: Participants will be randomized to receive one of the IMPs drug in the standard dose. After 24 weeks the effect is assessed by subjective and objective measures. If the criteria set by the Danish Medicinal Council are met (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 22 May 2023
- Start date
- 27 Apr 2023
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Asthma
- NCT number
- NCT05942222
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 220
- From 27 Apr 2023 to the primary completion date, 1 Apr 2026
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic corticosteroid treatment within the last three months
- Endoscopic sinus surgery (ESS) within the last six months
- Participation-current or previous (within the last year)-in another investigational drug trial with monoclonal antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis.
- Previous treatment failure with one of the IMPs for any indication (treatment failure is defined as failure to achieve the desired therapeutic outcome or effectively manage a condition within an expected timeframe)
Other illness
- Hypersensitivity to the active substance or any of the excipients in the two IMPs
Lab values
- Eosinophilic blood cell count of ≥1.5x10\^9cells/L (at baseline, i.e. before first injection)
Other
- Non-adherent to medicine regimens
- Not able to understand spoken and/or written Danish
- Pronounced fear of needles
- Pregnant or breastfeeding patients
Who the study is looking for
- Bilateral polyps in nose and sinuses
- ESS within the last three years (unless unfit for surgery y- in this study defined as either a severe somatic disease, for which other specialist advise against surgery, e.g., cardiac disease, pulmonary disease, or coagulation disorder OR/AND severe anxiety which can either be due to previous traumatic experiences with surgery or the postoperative period, post-traumatic stress disorder or severe anxiety disorder. In cases of doubt, investigators can ask for a written statement from the general practitioner or a psychiatrists/psychologist))
- Optimal local treatment with saline irrigation and topical nasal steroids for at least three months (unless contraindicated)
- Evidence of type 2 inflammation
- Furthermore, patients must fulfil three out the following five criteria:
- Need for systemic corticosteroids (at least two courses/year OR long-term treatment \>3 months) or contraindication to systemic steroids
- Significantly impaired QoL (SNOT-22 score≥50)
- Significant LoS (SSIT-16 score 0-8)
- NPS ≥5 (with at least 2 on either side)
- Asthma diagnosis (requiring inhaled corticosteroid (ICS))
- Also: Age of 18 years or more and able to read and/or speak Danish
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg Universitetssygehus Syd Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Aarhus Universitetshospital, Skejby Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Sydvestjysk sygehus - Esbjerg Coordinator of this site? Confirm its status | Esbjerg | Denmark | Unknown status |
| Regionshospitalet Gødstrup Coordinator of this site? Confirm its status | Herning | Denmark | Unknown status |
| Nordsjællands Hospital Coordinator of this site? Confirm its status | Hillerød | Denmark | Unknown status |
| Sjællands Universitetshospital Køge Coordinator of this site? Confirm its status | Køge | Denmark | Unknown status |
| Odense Universitetshospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Sygehus Lillebælt - Vejle Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.