For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion criteria:


  1. Female or male patients aged 18 to 75 years inclusive
  2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
  3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
  4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
  5. Ongoing symptoms for at least 12 weeks prior to enrolment
  6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
  7. Bi-weekly mean NBS ≥ 1.5 at randomization
  8. SNOT-22 total score ≥ 20 at enrolment and randomization
  9. Documented physician-diagnosed asthma
  10. Blood eosinophil count of >2% or ≥150/μL at enrolment

EXCLUSION CRITERIA

Exclusion criteria:


Any nasal and/or sinus surgery within 3 months prior to enrolment


Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:


  1. Unilateral antrochoanal polyps
  2. Nasal septal deviation that occludes at least one nostril
  3. Current rhinitis medicamentosa
  4. Allergic fungal rhinosinusitis or allergic fungal sinusitis;
  5. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
  6. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
  7. Receipt of any marketed or investigational biologic product within 6 months of enrolment
  8. Currently pregnant or breastfeeding

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Nasal Polyposis

Age (in years)

18 - 75

Phase

Phase 3

Participants needed

295

Est. Completion Date

Oct 10, 2025

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04157335

Study number

D3252C00002

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