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

NCT04157335

TerminatedPhase 3

Sponsor: AstraZeneca

Conditions: Nasal Polyposis, Eosinophilic Chronic Rhinosinusitis

Interventions: Benralizumab 30 mg, Matched placebo

Countries: United States, Argentina, Australia, Belgium, Bulgaria, Chile, China, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 and DB period
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
11. LMS E≥M for Asian

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 (other eosinophil-driven diseases but CRSwNP) 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
Locations (116)
  • Huntington Beach, California, United States
  • Grand Junction, Colorado, United States
  • Gainesville, Florida, United States
  • Louisville, Kentucky, United States
  • White Marsh, Maryland, United States
  • The Bronx, New York, United States
  • White Plains, New York, United States
  • Tulsa, Oklahoma, United States
  • Bethlehem, Pennsylvania, United States
  • Fort Worth, Texas, United States
  • McKinney, Texas, United States
  • St. George, Utah, United States
  • Richmond, Virginia, United States
  • Bellingham, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Ciudad de Buenos Aire, Argentina
  • San Fernando, Argentina
  • Herston, Australia
  • Melbourne, Australia
  • Spearwood, Australia
  • Brussels, Belgium
  • Ghent, Belgium
  • Leuven, Belgium
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Quillota, Chile
  • Santiago, Chile
  • + 86 more on CT.gov