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Clinical Trials/JPRN-jRCT2031200306
JPRN-jRCT2031200306
Completed
Phase 3

A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study - MERIT

Sugiyama Yutaro0 sites160 target enrollmentJanuary 20, 2021
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Sugiyama Yutaro
Enrollment
160
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 20, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sugiyama Yutaro

Eligibility Criteria

Inclusion Criteria

  • •1\. 18 years of age and older inclusive, at the time of signing the informed consent.
  • •2\. Body weight greater than or equal to 40kg.
  • •3\. Male or female participants (with appropriate contraceptive methods) to be eligible for entry into the study.
  • •4\. A documented blood eosinophil count of over 2% in the 12 months prior to Visit 0 OR through a blood sample taken between Visit 0 and Visit 1\. ALL participants must meet blood eosinophil count of over 2% by Visit 1\.
  • •Participants with peripheral blood eosinophil count over 2% to 5% must also have comorbid bronchial asthma, aspirin intolerance, or nonsteroidal anti\-inflammatory drug intolerance at Visit 1 assessment in order to return for Visit 2\.
  • •5\. Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator
  • •6\. Participants who have had at least one of the following at Visit 1] previous nasal surgery for the removal of NP, have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP,
  • •medically unsuitable or intolerant to systemic corticosteroid
  • •7\. Participants with severe NP symptoms defined as a nasal obstruction VAS symptom score of \>5
  • •8\. Presence of symptoms of CRS as described by at least two different symptoms for at least 12 weeks prior to Visit 1\.

Exclusion Criteria

  • •\- As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. (e.g. symptomatic herpes zoster within 3 months prior to screening, evidence of tuberculosis \[TB] active or latent).
  • •\- Cystic fibrosis
  • •\- Eosinophilic granulomatosis with polyangiitis (also known as Churg Strauss syndrome), Young's, Kartagener's or dyskinetic ciliary syndromes.
  • •\- Antrochoanal polyps.
  • •\- Severe nasal septal deviation preventing full assesment of nasal polyps in both nostrils.
  • •\- Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening.
  • •\- Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
  • •\- Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of screening.
  • •\- Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1\.
  • •\- Participants where NP surgery is contraindicated in the opinion of the Investigator.

Outcomes

Primary Outcomes

Not specified

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