A Randomized, Real-world Head-to-head Study of Dupilumab Versus Mepolizumab in Danish CRSwNP Patients

Launched by RIGSHOSPITALET, DENMARK · Jul 3, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two medications, Dupilumab and Mepolizumab, to see which one works better for treating severe chronic rhinosinusitis with nasal polyps in Danish patients. The study will look at how each drug affects patients over a period of 24 weeks, using both personal feedback from patients about their symptoms and a doctor's assessment of the size of nasal polyps. After this initial period, if a patient doesn’t respond well to the first drug, they may switch to the other drug for an additional 24 weeks.

To participate in this trial, patients need to be at least 18 years old, have nasal polyps, and have tried other treatments without enough success. They should also have certain symptoms that significantly affect their quality of life. However, there are some exclusions, such as recent surgery or certain health conditions. Participants will receive one of the study medications and will be monitored closely to see how well it works for them. This trial is currently recruiting participants, so those who meet the criteria can join and contribute to this important research.

Gender

ALL

Eligibility 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