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

Summary

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.

Timeline

Start

2019-11-25

Primary completion

2024-08-06

Completion

2025-04-07

Outcome

Missed primary endpoint

Stopped: “The study has a double-blind period and an open-label period. The study did not meet its primary endpoints after the primary LSLV and the decision was taken to terminate the study early.”

registry analysis (superiority test); Double Blind Benralizumab vs Double Blind Placebo; p = 0.1707; Difference in Least Squares Means -0.247 (95% CI -0.599 to 0.106); ANCOVA NCT04157335 ↗

registry analysis (superiority test); Double Blind Benralizumab vs Double Blind Placebo; p = 0.1831; Difference in Least Squares Means -0.155 (95% CI -0.383 to 0.073); ANCOVA NCT04157335 ↗

Publications

• Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Benralizumab	Monoclonal antibody	30 mg	Subcutaneous

Indications