Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis Wit… (NCT04157335) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
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.
United States, Argentina, Australia295 participantsStarted 2019-11-25
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56
Timeframe: Baseline to Week 56
2
Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.
. SNOT-22 total score ≥ 20 at enrolment and randomization
Exclusion criteria
. 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:
. 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