AstraZeneca: Eosinophilic Chronic Rhinosinusitis with Nasal Polyps (ORCHID)

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.

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:

  1. Any nasal and/or sinus surgery within 3 months prior to enrolment
  2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:
    • Unilateral antrochoanal polyps
    • Nasal septal deviation that occludes at least one nostril
    • Current rhinitis medicamentosa
    • Allergic fungal rhinosinusitis or allergic fungal sinusitis;
  3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
  4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
  5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
  6. Currently pregnant or breastfeeding

For more information please call 502.893.0159 and ask for Research