Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
NCT ID: NCT04157335
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
293 participants
INTERVENTIONAL
2019-11-25
2025-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Benralizumab
Benralizumab administered subcutaneously
Benralizumab 30 mg
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.
Placebo
Placebo administered subcutaneously
Matched placebo
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).
Interventions
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Benralizumab 30 mg
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 placebo
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
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Inclusion Criteria
2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening and DB period
3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
5. Ongoing symptoms for at least 12 weeks prior to enrolment
6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment
7. Bi-weekly mean NBS ≥ 1.5 at randomization
8. SNOT-22 total score ≥ 20 at enrolment and randomization
9. Documented physician-diagnosed asthma
10. Blood eosinophil count of \>2% or ≥150/μL at enrolment
11. LMS E≥M for Asian
Exclusion Criteria
2. 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;
3. 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
4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
6. Currently pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Luo Zhang, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Research Site
Huntington Beach, California, United States
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Grand Junction, Colorado, United States
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Gainesville, Florida, United States
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Louisville, Kentucky, United States
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White Marsh, Maryland, United States
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The Bronx, New York, United States
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White Plains, New York, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Fort Worth, Texas, United States
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McKinney, Texas, United States
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St. George, Utah, United States
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Richmond, Virginia, United States
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Bellingham, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad de Buenos Aire, , Argentina
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San Fernando, , Argentina
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Herston, , Australia
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Melbourne, , Australia
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Spearwood, , Australia
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Quillota, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Changsha, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Foshan, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Jinan, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Ürümqi, , China
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Wuhan, , China
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Xi'an, , China
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Xi'an, , China
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Yantai, , China
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Marseille, , France
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Toulouse, , France
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Siófok, , Hungary
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Székesfehérvár, , Hungary
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Tatabánya, , Hungary
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Catanzaro, , Italy
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Pisa, , Italy
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Roma, , Italy
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Roma, , Italy
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Chiba, , Japan
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Fujisawa-shi, , Japan
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Hiroshima, , Japan
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Ichikawa-shi, , Japan
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Iida-shi, , Japan
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Kawasaki-shi, , Japan
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Kumamoto, , Japan
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Meguro-ku, , Japan
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Meguro-ku, , Japan
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Minatoku, , Japan
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Moriguchi-shi, , Japan
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Nagaoka-shi, , Japan
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Osaka, , Japan
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Shinjuku-ku, , Japan
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Yoshida-gun, , Japan
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Bydgoszcz, , Poland
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Elblag, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Nadarzyn, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
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Łodź, , Poland
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Izhevsk, , Russia
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Penza, , Russia
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Saint Petersburg, , Russia
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Phitsanulok, , Thailand
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Aydin, , Turkey (Türkiye)
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Bakırköy, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Malatya, , Turkey (Türkiye)
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Other Identifiers
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2023-507987-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-000267-72
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3252C00002
Identifier Type: -
Identifier Source: org_study_id
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