Last updated on March 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nasal polyp
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
  2. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent form.
  3. 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).
  4. CT Lund Mackay score for ethmoid maxillary as determined by the study Imaging Core lab.
  5. 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
  6. 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.
  7. SNOT-22 total score 20 at enrolment (Visit 1).

Exclusion Criteria:

  1. Patients who have undergone any nasal and/or sinus surgery within 3 months prior to Visit 1.
  2. 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.
  3. 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.
  4. Known history of allergy or reaction to any component of the Investigational product formulation.
  5. 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.
  6. Alanine aminotransferase or aspartate aminotransferase level 3 times the upper limit of normal.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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