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Clinical Trials/2022-502250-14-00
2022-502250-14-00
Active, not recruiting
Phase 4

Treatment of rhinosinusitis with nasal polyposis with dupilumab and mepolizumab: A randomized, multi-centre, head-to-head comparison in real-world Danish patients

Rigshospitalet9 sites in 1 country220 target enrollmentStarted: March 22, 2023Last updated:
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Overview

Phase
Phase 4
Status
Active, not recruiting
Enrollment
220
Locations
9
Primary Endpoint
Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To compare the efficacy of mepolizumab versus dupilumab on objective and subjective symptoms of CRSwNP and related comorbidities in an attempt to determine non-inferiority between the two, or possibly; superiority of dupilumab over mepolizumab.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Chronic Rhinosinusitis with bilateral nasal polyposis
  • •Age above 18 years
  • •Able to read and/or speak Danish
  • •Evidence of type 2 inflammation as measured by either eosinophilia in blood or tissue (in accordance with EPOS2020), or late-onset eosinophilic asthma
  • •At least one endoscopic sinus surgery within the previous seven years (or not being fit to undergo sinus surgery)
  • •Adherence to nasal steroid spray and nasal douches twice a day for a period of at least three months until start of treatment
  • •Additionally: at least three of the following five: 1) need for systemic corticosteroids (OCS), at least two/year or one long term treatment lasting more than three months, or having contraindications to OCSs
  • •Sino-nasal outcome test 22 (SNOT-22) score of at least 50
  • •Reduced sense of smell (Defined as Sniffin Sticks-Evaluation Identification Test 16 (UPSIT-16) score 0-8
  • •Nasal polyp score (NPS) of minimum 2 on both sides, and a minimum score of 5 in total

Exclusion Criteria

  • •Systemic corticosteroid treatment within the last three months
  • •Pregnant or breastfeeding patients.
  • •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
  • •Prior treatment with any biologic drug aimed at type II disease within the previous six months
  • •Prior treatment failure with one of the two IMPs for any indication
  • •Eosinophilic blood cell count of ≥1.5x109cells/L (at baseline, i.e. before first injection)
  • •Pronounced fear of needles

Outcomes

Primary Outcomes

Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks

Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks

Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks

Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks

Secondary Outcomes

  • Change in loss of smell (Proportion with SSIT-16 improved to >8)
  • Improvement in asthma (measured by proportion with ACQ>0.5)
  • Improvement on visual analog scale measuring impact on quality of life of CRSwNP
  • Tympanometry - proportion with change from B-curve to A or C curve.
  • Expired Nitrous oxide (FeNO) - proportion with less than 25 ppb
  • Improvement in subjective smell function by visual analog scale
  • Improvement in aspirin-exacerbated-respiratory-intolerance (AERD) measured by visual analog scale.
  • Improvement in NPS at 52 weeks
  • Improvement in SNOT-22 at 52 weeks
  • Proportion meeting the response criteria set by the Danish Medicines council
  • Change in FEV1
  • Proportion of subjects needing rescue treatment (systemic corticosteroids or sinus surgery)
  • Change in Nasal Congestion Score (NCS)
  • Chang in radiologic sinus opacification (Lund-Mackey score)

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Christian von Buchwald

Scientific

Rigshospitalet

Study Sites (9)

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