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

NCT05942222 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2022-ENT-3
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Asthma; Eosinophilic; Eosinophilia

Outcome Measures

Primary Outcomes (2)

• SNOT-22

  Sino-Nasal Outcome Test 22 - change in score since baseline is measured.

  Week 24

• NPS

  Nasal Polyp Score (0-8): 0 is no polyps, 4 is polyps extending below inferior turbinate's lower border. Each side is scored. The change in score at week 24 since baseline is measured.

  Week 24

Secondary Outcomes (9)

• SNOT-22

  Week 48

• NPS

  Week 48

• Smell score (Sniffin' Sticks Identification Test-16- SSIT-16)

  Week 48

• Asthma control (Asthma Control Questionnaire)

  Week 48

• Nasal Congestion Score (NCS)

  Week 48

Study Arms (5)

Dupilumab week 0-24 300 mg/2 weeks

ACTIVE COMPARATOR

Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks

Biological: dupilumab

Mepolizumab week 0-24 100 mg/4 weeks

ACTIVE COMPARATOR

Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks

Biological: mepolizumab

Dupilumab week 24-48 300 mg/4 weeks

ACTIVE COMPARATOR

Increased dosage interval of Dupixent i.e. 300 mg s.c. every 4 weeks - for subjects on Dupixent who met the 24 weeks effect criteria

Biological: dupilumab

Dupilumab week 24-48 300 mg/2 weeks

ACTIVE COMPARATOR

Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks but for subjects who have crossed over after 24 weeks due to unmet effect criteria.

Biological: dupilumab

Mepolizumab week 24-48 100 mg/4 weeks

ACTIVE COMPARATOR

Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks but for subjects who have crossed-over after 24 weeks due to unmet effect criteria.

Biological: mepolizumab

Interventions

dupilumab BIOLOGICAL

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

Also known as: Dupixent

Dupilumab week 0-24 300 mg/2 weeks; Dupilumab week 24-48 300 mg/2 weeks; Dupilumab week 24-48 300 mg/4 weeks

mepolizumab BIOLOGICAL

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

Also known as: Nucala

Mepolizumab week 0-24 100 mg/4 weeks; Mepolizumab week 24-48 100 mg/4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (9)

Aalborg Universitetssygehus Syd

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital Skejby

Aarhus, 8200, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Sydvestjysk Sygehus Esbjerg

Esbjerg, 6700, Denmark

Location

Regionshospitalet Gødstrup

Herning, 7400, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Sjællands Universitetshospital Køge

Køge, 4600, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Sygehus Lillebælt Vejle

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Eosinophilia; Eosinophilia

Interventions

dupilumab; mepolizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Christian Pedersen, MD

  Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Christian von Buchwald

  Department of ORL, Head and Neck Surgery & Audiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 12, 2023
• Study Start: April 27, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (9)