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ACTIVE NOT RECRUITING

NCT05942222

PHASE4

A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

Summary

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.

Official title: Treatment of Rhinosinusitis With Nasal Polyposis With Dupilumab and Mepolizumab: A Randomized, Multi-centre, Head-to-head Comparison in Real-world Danish Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-04-27

Completion Date

2026-05-01

Last Updated

2025-07-01

Healthy Volunteers

Conditions

Chronic Rhinosinusitis With Nasal Polyps Asthma; Eosinophilic Eosinophilia

Interventions

BIOLOGICAL

dupilumab

Subcutaneus injections in standard doses, i.e. 300 mg s.c. every 2 weeks.

BIOLOGICAL

mepolizumab

Subcutaneus injections in standard doses, i.e. 100 mg s.c. every 4 weeks.

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

Locations (9)

Aalborg Universitetssygehus Syd

Aalborg, Denmark

Aarhus Universitetshospital Skejby

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Sydvestjysk Sygehus Esbjerg

Esbjerg, Denmark

Regionshospitalet Gødstrup

Herning, Denmark

Nordsjællands Hospital

Hillerød, Denmark

Sjællands Universitetshospital Køge

Køge, Denmark

Odense Universitetshospital

Odense, Denmark

Sygehus Lillebælt Vejle

Vejle, Denmark