Comparing dupilumab and mepolizumab for treating severe nasal polyps in Denmark
Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients
This study is testing whether dupilumab works better than mepolizumab for treating severe nasal polyps in Danish patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | dupilumab, mepolizumab |
| Locations | 9 sites (Aalborg and 8 other locations) |
| Trial ID | NCT05942222 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two biological drugs, dupilumab and mepolizumab, in treating severe chronic rhinosinusitis with nasal polyps in Danish patients. Participants will be randomly assigned to receive one of the two medications for 24 weeks, after which their symptoms will be evaluated using both subjective and objective measures. If the initial treatment does not meet predefined effectiveness criteria, patients will switch to the alternative drug for an additional 24 weeks. The study will include 220 patients across multiple sites in Denmark, with the goal of establishing non-inferiority and potential superiority of dupilumab over mepolizumab.
Who should consider this trial
Good fit: Ideal candidates are Danish patients with severe, uncontrolled chronic rhinosinusitis with nasal polyps who have not responded adequately to standard treatments.
Not a fit: Patients with mild symptoms or those who have not been diagnosed with chronic rhinosinusitis with nasal polyps may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the most effective treatment for patients with severe chronic rhinosinusitis with nasal polyps.
How similar studies have performed: Other studies have shown promising results with similar biological treatments for chronic rhinosinusitis, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion criteria * Systemic corticosteroid treatment within the last three months * Endoscopic sinus surgery (ESS) within the last six months * Non-adherent to medicine regimens * Hypersensitivity to the active substance or any of the excipients in the two IMPs * Not able to understand spoken and/or written Danish * 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) * Eosinophilic blood cell count of ≥1.5x10\^9cells/L (at baseline, i.e. before first injection) * Pronounced fear of needles * Pregnant or breastfeeding patients
Where this trial is running
Aalborg and 8 other locations
- Aalborg Universitetssygehus Syd — Aalborg, Denmark (Recruiting)
- Aarhus Universitetshospital Skejby — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Sydvestjysk Sygehus Esbjerg — Esbjerg, Denmark (Recruiting)
- Regionshospitalet Gødstrup — Herning, Denmark (Recruiting)
- Nordsjællands Hospital — Hillerød, Denmark (Recruiting)
- Sjællands Universitetshospital Køge — Køge, Denmark (Recruiting)
- Odense Universitetshospital — Odense, Denmark (Recruiting)
- Sygehus Lillebælt Vejle — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Christian Pedersen, MD — Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
- Study coordinator: Christian Pedersen, MD
- Email: christian.korsgaard.pedersen.01@regionh.dk
- Phone: +4525301186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.