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Nasal PolyposisPhase 3ORCHIDNCT04157335

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

A Phase 3 study testing Benralizumab 30 mg in people with Nasal Polyposis and Eosinophilic Chronic Rhinosinusitis, run by AstraZeneca at 116 sites in 17 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Benralizumab 30 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
295 participants
Where
116 sitesin 17 countries
Study dates
25 Nov 2019to 7 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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;
Show all 10Show fewer
  • 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

Trial locations and contacts

116 sites in 17 countries.

116 sites in 17 countries

China27 sites

  • Research Site

    Beijing, 100044

  • Research Site

    Beijing, 100191

  • Research Site

    Beijing, 100730

  • Research Site

    Changchun, 130061

  • Research Site

    Changsha, 410008

  • Research Site

    Changsha, 410013

  • Research Site

    Changsha

  • Research Site

    Chengdu, 610041

  • Research Site

    Chengdu, 610072

  • Research Site

    Chongqing, 400042

  • Research Site

    Foshan, 528000

  • Research Site

    Guangzhou, 510000

  • Research Site

    Guangzhou, 510180

  • Research Site

    Hangzhou, 310003

  • Research Site

    Jinan, 250014

  • Research Site

    Nanchang, 330006

  • Research Site

    Nanjing, 210029

  • Research Site

    Nanning, 530021

  • Research Site

    Qingdao, 266071

  • Research Site

    Shanghai, 200065

  • Research Site

    Shanghai, 200092

  • Research Site

    Tianjin, 300050

  • Research Site

    Ürümqi, 830054

  • Research Site

    Wuhan, 430022

  • Research Site

    Xi'an, 710004

  • Research Site

    Xi'an, 710061

  • Research Site

    Yantai, 264000

Other trials in China

United States15 sites

  • Research Site

    Bellingham, Washington, 98225

  • Research Site

    Bethlehem, Pennsylvania, 18017

  • Research Site

    Fort Worth, Texas, 76109

  • Research Site

    Gainesville, Florida, 32605

  • Research Site

    Grand Junction, Colorado, 81501

  • Research Site

    Huntington Beach, California, 92647

  • Research Site

    Louisville, Kentucky, 40220

  • Research Site

    McKinney, Texas, 75070

  • Research Site

    Milwaukee, Wisconsin, 53228

  • Research Site

    Richmond, Virginia, 23235

  • Research Site

    St. George, Utah, 84790

  • Research Site

    The Bronx, New York, 10461

  • Research Site

    Tulsa, Oklahoma, 74136

  • Research Site

    White Marsh, Maryland, 21162

  • Research Site

    White Plains, New York, 10605

Other trials in United States

Japan15 sites

  • Research Site

    Chiba, 262-0015

  • Research Site

    Fujisawa-shi, 251-0052

  • Research Site

    Hiroshima, 734-8551

  • Research Site

    Ichikawa-shi, 272-0143

  • Research Site

    Iida-shi, 395-8505

  • Research Site

    Kawasaki-shi, 211-0063

  • Research Site

    Kumamoto, 860-0814

  • Research Site

    Meguro-ku, 153-0061

  • Research Site

    Meguro-ku, 153-8515

  • Research Site

    Minatoku, 105-8471

  • Research Site

    Moriguchi-shi, 570-0074

  • Research Site

    Nagaoka-shi, 940-2085

  • Research Site

    Osaka, 540-0008

  • Research Site

    Shinjuku-ku, 160-0017

  • Research Site

    Yoshida-gun, 910-1193

Other trials in Japan

Poland8 sites

  • Research Site

    Bydgoszcz, 85-231

  • Research Site

    Elblag, 82-300

  • Research Site

    Krakow, 31-513

  • Research Site

    Łodź, 90-153

  • Research Site

    Lublin, 20-552

  • Research Site

    Nadarzyn, 05-830

  • Research Site

    Poznan, 60-805

  • Research Site

    Wroclaw, 53-301

Other trials in Poland

Hungary7 sites

  • Research Site

    Budapest, 1033

  • Research Site

    Budapest, 1046

  • Research Site

    Győr, 9024

  • Research Site

    Kaposvár, 7400

  • Research Site

    Siófok, 8600

  • Research Site

    Székesfehérvár, 8000

  • Research Site

    Tatabánya, 2800

Other trials in Hungary

Taiwan6 sites

  • Research Site

    Taipei, 10002

  • Research Site

    Taipei, 110

  • Research Site

    Taipei, 11217

  • Research Site

    Taipei, 114

  • Research Site

    Taipei, 235

  • Research Site

    Taoyuan, 333

Other trials in Taiwan

Thailand6 sites

  • Research Site

    Bangkok, 10330

  • Research Site

    Bangkok, 10400

  • Research Site

    Bangkok, 10700

  • Research Site

    Chiang Mai, 50200

  • Research Site

    Khon Kaen, 40002

  • Research Site

    Phitsanulok, 65000

Other trials in Thailand

Argentina4 sites

  • Research Site

    Buenos Aires, C1121 ABE

  • Research Site

    Buenos Aires, C1414AIF

  • Research Site

    Ciudad de Buenos Aire, C1425BEN

  • Research Site

    San Fernando, B1646EBJ

Other trials in Argentina

Chile4 sites

  • Research Site

    Quillota, 2260000

  • Research Site

    Santiago, 7500588

  • Research Site

    Santiago, 8150000

  • Research Site

    Talca, 3481349

Other trials in Chile

Italy4 sites

  • Research Site

    Catanzaro, 88100

  • Research Site

    Pisa, 56124

  • Research Site

    Roma, 00161

  • Research Site

    Roma, 00168

Other trials in Italy

Turkey (Türkiye)4 sites

  • Research Site

    Aydin, 09100

  • Research Site

    Bakırköy, 34147

  • Research Site

    Izmir, 35340

  • Research Site

    Malatya, 44280

Other trials in Turkey (Türkiye)

Australia3 sites

  • Research Site

    Herston, 4029

  • Research Site

    Melbourne, 3004

  • Research Site

    Spearwood, 6163

Other trials in Australia

Belgium3 sites

  • Research Site

    Brussels, 1200

  • Research Site

    Ghent, 9000

  • Research Site

    Leuven, 3000

Other trials in Belgium

Bulgaria3 sites

  • Research Site

    Plovdiv, 4001

  • Research Site

    Sofia, 1303

  • Research Site

    Sofia, 1606

Other trials in Bulgaria

Russia3 sites

  • Research Site

    Izhevsk, 426061

  • Research Site

    Penza, 440067

  • Research Site

    Saint Petersburg, 196158

Other trials in Russia

France2 sites

  • Research Site

    Marseille, 13005

  • Research Site

    Toulouse, 31059

Other trials in France

Vietnam2 sites

  • Research Site

    Hanoi, 100000

  • Research Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: 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)

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.

Read the detailed description

Approximately 250 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 (Open Label Extension), during which all patients will receive 8 doses of benralizumab 30 mg. Patients in Benra arm during DB period will receive one dummy dose for the second dose during OLE (Open Label Extension). The last study visit will occur at 8 weeks after the last dose of IP (Week 112/FU). Patients who do not enter OLE (Open Label Extension), will have their last study visit at Week 56 (EoDB) for follow-up and without administration of IP.

Being tested
Benralizumab 30 mg, Matched placebo
Keywords
Benralizumab, Eosinophilic Chronic Rhinosinusitis with Nasal Polyps, Nasal Polyps, Asthma
Medical subject headings
Nasal Polyps, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Benralizumab 30 mgBiological

    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.

  • Matched placeboBiological

    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).

Study groups in NCT04157335
Study groupRoleWhat they receive
BenralizumabExperimentalBenralizumab administered subcutaneously
Receives: Biological: Benralizumab 30 mg
PlaceboPlacebo comparatorPlacebo administered subcutaneously
Receives: Biological: Matched placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Week 56

  2. 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.

    Measured: Baseline to week 56

Secondary outcomes (10)

  1. Change From Baseline in Difficulty With Sense of Smell (DSS) Score at Week 56.

    The DSS is an item in the NPSD. Patients were asked to rate the severity of their worst difficulty with sense of smell 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 DSS 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 of DSS was calculated if at least 8 days in each 14-day period have evaluable data; otherwise the bi-weekly mean was set to missing.

    Measured: Baseline to Week 56

  2. Sinus Opacification by CT Scan at Week 56.

    Change from baseline in Lund- Mackay score (LMS). The Lund-Mackay score scoring system is used to provide a quantitative assessment of nasal sinuses on sinus CT scans. Based on the sinus CT images, the five sinuses (maxillary, anterior ethmoid, posterior ethmoid, sphenoid and frontal) on each site are score by central radiologist as follows: (0-Normal; 1-Partial Opacification; 2-Total Opacification). The osteomeatal complex is scored for right and left sides (0 - Not occluded; 2- Occluded). The total score ranges from 0 to 24 (higher scores indicate poorer outcomes).

    Measured: Baseline to Week 56

  3. Disease Specific Health-related Quality of Life (HRQoL): Change From Baseline in SinoNasal Outcome Test (SNOT-22) Score at Week 56.

    SinoNasal Outcome Test 22 scores are participant-reported and assess physical problems, functional limitations and emotional consequences of SinoNasal conditions. Patient-reported symptom severity and symptom impact over the past 2 weeks are captured via a 6-point scale (0-No Problem to 5-Problem as bad as it can be). The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes).

    Measured: Baseline to Week 56

  4. Time to First Nasal Polyp Surgery

    Time to the first surgery for CRSwNP= Start date of the first surgery for CRSwNP - date of randomisation + 1

    Measured: Baseline to Week 56

  5. Time to First SCS Course for CRSwNP

    Time to the first SCS use for CRSwNP = Start date of the first SCS use for CRSwNP - date of randomisation + 1

    Measured: Baseline to Week 56

  6. Time to First NP Surgery and/or SCS Use for CRSwNP

    Time to first surgery and/or SCS use for CRSwNP = earlier date of (start date of first surgery for CRSwNP, start date of first SCS use for CRSwNP) - date of randomisation + 1

    Measured: Baseline to Week 56

  7. Change From Baseline in Bi-weekly Mean Nasal Polyps Symptom Diary Total Symptom Score at Week 56.

    The participant completed the nasal polyposis symptom diary each morning throughout the study. The participant was asked to consider their experience with nasal polyposis/nasal polyps over the past 24 hours when responding to each question. Participants were asked to report their experience with nasal polyposis symptoms (nasal blockage, nasal congestion, runny nose, postnasal drip (mucus drainage down the throat), headache, facial pain, facial pressure, difficulty with sense of smell). Participants reported the severity of each symptom and symptom impact at its worst using a 4-point verbal rating scale (0-None to 3-Severe). A total symptom score (range from 0 to 24) was calculated by taking the sum of the 8 equally weighted symptom items. Higher scores indicate greater symptom severity.

    Measured: Baseline to Week 56

  8. Percentage of Participants With Surgery and/or Use SCS for CRSwNP

    Nasal polyps surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g. polypectomy, endoscopic sinus surgery).

    An SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course > 7)

    Measured: Baseline to Week 56

  9. Percentage of Participants With Surgery for CRSwNP

    Nasal polyps surgery is defined as any procedure involving instruments resulting in incision and removal of tissue (e.g. polypectomy, endoscopic sinus surgery).

    Measured: Baseline to Week 56

  10. Percentage of Participants With SCS Use for CRSwNP

    An SCS course can be considered as a new course if the start date is preceded by at least 7 days after the end date of the last SCS course for CRSwNP (i.e. start date of the new course - end date of the last course > 7)

    Measured: Baseline to Week 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2019
  2. Study start25 Nov 2019
  3. Primary completion6 Aug 2024
  4. Study completion7 Apr 2025

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04157335
Sponsor's protocol ID
D3252C00002
Other IDs
2023-507987-38-00, 2021-000267-72, 2023
Acronym
ORCHID
Status last verified
Jan 2026
First submitted
23 Oct 2019
Last updated
19 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 33710614

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benralizumab 30 mg in people with Nasal Polyposis and Eosinophilic Chronic Rhinosinusitis, run by AstraZeneca at 116 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in China, United States, Japan, Poland, Hungary and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Endoscopic Total Nasal Polyp Score (NPS) at Week 56 (time frame: Baseline to Week 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04157335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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