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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Nasal Polyposis, Eosinophilic Chronic Rhinosinusitis

In brief

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.

Key facts

Study ID

NCT04157335

Run by

AstraZeneca

People needed

295

Starts

2019-11-25

Expected to finish

2025-04-07

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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:
• Unilateral antrochoanal polyps
• Nasal septal deviation that occludes at least one nostril
• Current rhinitis medicamentosa
• Allergic fungal rhinosinusitis or allergic fungal sinusitis;
• 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
• Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
• Receipt of any marketed or investigational biologic product within 6 months of enrolment
• Currently pregnant or breastfeeding

Where it is running

• Research Site — Grand Junction, Colorado, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — White Marsh, Maryland, United States
• Research Site — The Bronx, New York, United States
• Research Site — White Plains, New York, United States
• Research Site — Tulsa, Oklahoma, United States
• Research Site — Bethlehem, Pennsylvania, United States
• Research Site — Fort Worth, Texas, United States
• Research Site — McKinney, Texas, United States
• Research Site — St. George, Utah, United States
• Research Site — Richmond, Virginia, United States
• Research Site — Bellingham, Washington, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Buenos Aires, Argentina
• Research Site — Buenos Aires, Argentina
• Research Site — Ciudad de Buenos Aire, Argentina
• Research Site — San Fernando, Argentina
• Research Site — Herston, Australia
• Research Site — Melbourne, Australia
• Research Site — Spearwood, Australia
• Research Site — Brussels, Belgium
• Research Site — Ghent, Belgium
• Research Site — Leuven, Belgium
• Research Site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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