Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

  • STATUS
    Recruiting
  • End date
    Jul 12, 2022
  • participants needed
    148
  • sponsor
    AstraZeneca
Updated on 30 March 2020
aspirin
corticosteroids
rhinosinusitis
asthma
eosinophil count
benralizumab
respiratory disease
polyposis

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

Description

Approximately 148 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 5-week screening/run in period. Patients who meet eligibility criteria will be randomised 1:1 at Week 0 (Day 0) to receive either placebo or benralizumab 30 mg SC every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). An end of treatment visit will be conducted at Week 56.The first up to 74 patients that complete the 56-week treatment will have a 24-week follow-up (FU) period without dosing to assess durability of benefit. These patients will have the FU for the final safety assessment at week 80. The remaining patients will have a last FU visit 12 weeks after last dose for final safety assessments at week 60.

Details
Treatment Matched placebo, Benralizumab 30 mg
Clinical Study IdentifierNCT04157335
SponsorAstraZeneca
Last Modified on30 March 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Nasal polyp?
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent form
Patients with bilateral sinonasal polyps that, despite treatment with standard of care including a history of treatment with Systemic corticosteroids (oral, parenteral) or prior surgery for Nasal polyps have severity consistent with a need for surgery as described by
A minimum total Nasal polyp score of 5 out of a maximum score of 8 (with a unilateral score of at least 2 for each nostril) at Visit 1 and continuously maintained at Visit 2 to meet the randomisation criterion as determined by the study Imaging Core Lab
Ongoing symptoms for at least 12 weeks prior to Visit 1
Patient-reported moderate to severe nasal blockage (score 2 or 3) over the 2-weeks prior to Visit 1 (2-week recall assessment of symptoms, scores 0-none to 3-severe)
CT Lund Mackay score for ethmoid maxillary as determined by the study Imaging Core lab
Patients meet one of the following criteria
Blood eosinophil count > 5% as determined by central lab
Blood eosinophil count is >2% and 5% as determined by central lab with a diagnosis of asthma and/or Aspirin exacerbated respiratory disease or NSAID exacerbated respiratory disease
Patients who are on Intranasal corticosteroids or leukotriene receptor antagonists (LTRAs), need to be at stable dose for at least 30 days prior to Visit 1
SNOT-22 total score 20 at enrolment (Visit 1)

Exclusion Criteria

Patients who have undergone any nasal and/or sinus surgery within 3 months prior to Visit 1
Patients with conditions or concomitant disease that makes them non evaluable for the co-primary efficacy endpoint such as
Unilateral antrochoanal polyps
Nasal septal deviation that occludes at least one nostril
Acute sinusitis, nasal infection, or upper respiratory infection at screening or in the 2 weeks before screening
Current rhinitis medicamentosa
Allergic fungal rhinosinusitis or allergic fungal sinusitis
Nasal cavity tumours
Patients experiencing an asthma exacerbation requiring systemic (oral and/or parenteral) corticosteroids treatment or hospitalisation (>24hrs) for treatment of asthma within 4 weeks prior to Visit 1
Known history of allergy or reaction to any component of the Investigational product formulation
Prior/concomitant therapy: use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, or any experimental anti-inflammatory therapy) within 3 months prior to V1 and during the study period
Alanine aminotransferase or aspartate aminotransferase level 3 times the upper limit of normal
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