Study 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.
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
ORCHID
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
3 other identifiers
interventional
295
17 countries
116
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2019
Longer than P75 for phase_3
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
November 8, 2019
CompletedStudy Start
First participant enrolled
November 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2025
CompletedResults Posted
Study results publicly available
February 19, 2026
CompletedFebruary 19, 2026
January 1, 2026
4.7 years
October 23, 2019
November 28, 2025
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56
The total nasal polyp score (NPS) is the sum of the right and left nostril scores (maximum of 8), as evaluated by nasal endoscopy. Higher scores indicate greater symptom severity. The left and right score will be based on a central read with a scale from 0 to 4. Each nasal endoscopy is evaluated by two independent physician reviewers.
Baseline to Week 56
Change From Baseline in Mean Nasal Blockage Score (NBS) at Week 56.
The NBS is an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0 - none; 1 - mild; 2 - moderate; 3 - severe. Higher scores indicate greater symptom severity. The NBS and the changes from baseline were summarised every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Bi-weekly mean were calculated if at least 8 days in each 14-day period had evaluable data; otherwise, the biweekly mean was set to missing.
Baseline to week 56
Secondary Outcomes (10)
Change From Baseline in Difficulty With Sense of Smell (DSS) Score at Week 56.
Baseline to Week 56
Sinus Opacification by CT Scan at Week 56.
Baseline to Week 56
Disease Specific Health-related Quality of Life (HRQoL): Change From Baseline in SinoNasal Outcome Test (SNOT-22) Score at Week 56.
Baseline to Week 56
Time to First Nasal Polyp Surgery
Baseline to Week 56
Time to First SCS Course for CRSwNP
Baseline to Week 56
- +5 more secondary outcomes
Study Arms (2)
Benralizumab
EXPERIMENTALBenralizumab administered subcutaneously
Placebo
PLACEBO COMPARATORPlacebo administered subcutaneously
Interventions
Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume. Benralizumab 30 mg subcutaneously will be injected 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). For OLE, Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses and every 8 weeks for the rest 5 doses. For the patients on Benralizumab treatment during double blind period, placebo will be dosed at the second dose during OLE.
Matching placebo solution for injection in accessorized pre-filled syringe. 1 ml fill volume. Matching placebo subcutaneously will be injected 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).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (116)
Research Site
Huntington Beach, California, 92647, United States
Research Site
Grand Junction, Colorado, 81501, United States
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Gainesville, Florida, 32605, United States
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Louisville, Kentucky, 40220, United States
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White Marsh, Maryland, 21162, United States
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The Bronx, New York, 10461, United States
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White Plains, New York, 10605, United States
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Tulsa, Oklahoma, 74136, United States
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Bethlehem, Pennsylvania, 18017, United States
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Fort Worth, Texas, 76109, United States
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McKinney, Texas, 75070, United States
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St. George, Utah, 84790, United States
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Richmond, Virginia, 23235, United States
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Bellingham, Washington, 98225, United States
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Milwaukee, Wisconsin, 53228, United States
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Buenos Aires, C1121 ABE, Argentina
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Buenos Aires, C1414AIF, Argentina
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Ciudad de Buenos Aire, C1425BEN, Argentina
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San Fernando, B1646EBJ, Argentina
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Herston, 4029, Australia
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Melbourne, 3004, Australia
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Spearwood, 6163, Australia
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Brussels, 1200, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Plovdiv, 4001, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1606, Bulgaria
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Quillota, 2260000, Chile
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Santiago, 7500588, Chile
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Santiago, 8150000, Chile
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Talca, 3481349, Chile
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Beijing, 100044, China
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Beijing, 100191, China
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Beijing, 100730, China
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Changchun, 130061, China
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Changsha, 410008, China
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Changsha, 410013, China
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Changsha, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400042, China
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Foshan, 528000, China
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Guangzhou, 510000, China
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Guangzhou, 510180, China
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Hangzhou, 310003, China
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Jinan, 250014, China
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Nanchang, 330006, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Qingdao, 266071, China
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Shanghai, 200065, China
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Shanghai, 200092, China
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Tianjin, 300050, China
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Ürümqi, 830054, China
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Wuhan, 430022, China
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Xi'an, 710004, China
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Xi'an, 710061, China
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Yantai, 264000, China
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Marseille, 13005, France
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Toulouse, 31059, France
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Budapest, 1033, Hungary
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Budapest, 1046, Hungary
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Győr, 9024, Hungary
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Kaposvár, 7400, Hungary
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Siófok, 8600, Hungary
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Székesfehérvár, 8000, Hungary
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Tatabánya, 2800, Hungary
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Catanzaro, 88100, Italy
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Pisa, 56124, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Chiba, 262-0015, Japan
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Fujisawa-shi, 251-0052, Japan
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Hiroshima, 734-8551, Japan
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Ichikawa-shi, 272-0143, Japan
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Iida-shi, 395-8505, Japan
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Kawasaki-shi, 211-0063, Japan
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Kumamoto, 860-0814, Japan
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Meguro-ku, 153-0061, Japan
Research Site
Meguro-ku, 153-8515, Japan
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Minatoku, 105-8471, Japan
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Moriguchi-shi, 570-0074, Japan
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Nagaoka-shi, 940-2085, Japan
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Osaka, 540-0008, Japan
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Shinjuku-ku, 160-0017, Japan
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Yoshida-gun, 910-1193, Japan
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Bydgoszcz, 85-231, Poland
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Elblag, 82-300, Poland
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Krakow, 31-513, Poland
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Lublin, 20-552, Poland
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Nadarzyn, 05-830, Poland
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Poznan, 60-805, Poland
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Wroclaw, 53-301, Poland
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Łodź, 90-153, Poland
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Izhevsk, 426061, Russia
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Penza, 440067, Russia
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Saint Petersburg, 196158, Russia
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 114, Taiwan
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Taipei, 235, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
Research Site
Khon Kaen, 40002, Thailand
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Phitsanulok, 65000, Thailand
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Aydin, 09100, Turkey (Türkiye)
Research Site
Bakırköy, 34147, Turkey (Türkiye)
Research Site
Izmir, 35340, Turkey (Türkiye)
Research Site
Malatya, 44280, Turkey (Türkiye)
Research Site
Hanoi, 100000, Vietnam
Research Site
Ho Chi Minh City, 700000, Vietnam
Related Publications (1)
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.
PMID: 33710614DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Luo Zhang, Prof. Dr.
Beijing Tongren Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
November 8, 2019
Study Start
November 25, 2019
Primary Completion
August 6, 2024
Study Completion
April 7, 2025
Last Updated
February 19, 2026
Results First Posted
February 19, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.