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

Phase 3

Active, not recruiting

• Conditions: Nasal Polyposis
• Interventions: Biological: Matched placebo; Biological: Benralizumab 30 mg

• Registration Number: NCT04157335
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Approximately 275 patients will be randomized to receive benralizumab 30 mg SC or matching placebo. After enrolment, eligible patients will enter a 6-week screening/run in period. Patients who meet eligibility criteria will be randomised 1:1 at Week 0 (Day 0) to receive either placebo or benralizumab 30 mg SC every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48). An end of treatment visit will be conducted at Week 56.All patients who complete the 56-week DB treatment period on investigational product (IP) may be eligible to continue into around one year OLE, during which all patients will receive 8 doses of benralizumab 30 mg. Patients in Benra arm during DB period will receive one dummy dose. The last study visit will occur at 8 weeks after the last dose of IP (Week 112/FU). Patients who do not enter OLE, will have their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-08
• Study Start: 2019-11-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-08-19
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Matched placebo	Placebo administered subcutaneously
Benralizumab	Benralizumab 30 mg	Benralizumab administered subcutaneously

Primary Outcome Measures

Name	Time	Method
Nasal Polyp Burden	Baseline and Week 56	Change from baseline in endoscopic total nasal polyp score (NPS).
Patient-reported Nasal Blockage (NB)	Baseline and week 56	Change from baseline in mean nasal blockage score (NBS).

Secondary Outcome Measures

Name	Time	Method
Systemic corticosteroid (SCS) use	Week 56	Time to first SCS course for NP
Sense of Smell	Week 56	Change from baseline in difficulty with sense of smell (DSS) score
Disease specific health-related quality of life (HRQoL)	Week 56	Change from baseline in SinoNasal Outcome Test (SNOT-22) score.
Sinus Opacification by CT Scan	Week 56	Change from baseline in Lund Mackay score
Nasal Polyp Surgery	Week 56	Time to first nasal polyp surgery
Symptoms associated with CRSwNP	Week 56	Change from baseline in nasal symptom score(s)

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam