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

Sponsor
Rigshospitalet, Denmark
Study ID
NCT05942222
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Asthma; Eosinophilic
  • Chronic Rhinosinusitis With Nasal Polyps
  • Eosinophilia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — BIOLOGICAL
    Subcutaneus injections in standard doses, i.e. 300 mg s.c. every 2 weeks.
  • mepolizumab — BIOLOGICAL
    Subcutaneus injections in standard doses, i.e. 100 mg s.c. every 4 weeks.

Study Details

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.

Key Dates

Start date
Apr 27, 2023
Status verified
Jun 2025
Primary completion
Apr 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dupilumab week 0-24 300 mg/2 weeks
    Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks
  • Active Comparator: Mepolizumab week 0-24 100 mg/4 weeks
    Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks
  • Active Comparator: Dupilumab week 24-48 300 mg/4 weeks
    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
  • Active Comparator: Dupilumab week 24-48 300 mg/2 weeks
    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.
  • Active Comparator: Mepolizumab week 24-48 100 mg/4 weeks
    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.

Primary Outcome Measure

SNOT-22 [ Time Frame: Week 24 ]

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