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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04157335




Registration number
NCT04157335
Ethics application status
Date submitted
23/10/2019
Date registered
8/11/2019
Date last updated
17/05/2024

Titles & IDs
Public title
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
Scientific 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)
Secondary ID [1] 0 0
2021-000267-72
Secondary ID [2] 0 0
D3252C00002
Universal Trial Number (UTN)
Trial acronym
ORCHID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasal Polyposis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Benralizumab 30 mg
Treatment: Other - Matched placebo

Experimental: Benralizumab - Benralizumab administered subcutaneously

Placebo comparator: Placebo - Placebo administered subcutaneously


Treatment: Other: 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).

Treatment: Other: 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).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Nasal Polyp Burden
Timepoint [1] 0 0
Baseline and Week 56
Primary outcome [2] 0 0
Patient-reported Nasal Blockage (NB)
Timepoint [2] 0 0
Baseline and week 56
Secondary outcome [1] 0 0
Sense of Smell
Timepoint [1] 0 0
Week 56
Secondary outcome [2] 0 0
Sinus Opacification by CT Scan
Timepoint [2] 0 0
Week 56
Secondary outcome [3] 0 0
Disease specific health-related quality of life (HRQoL)
Timepoint [3] 0 0
Week 56
Secondary outcome [4] 0 0
Nasal Polyp Surgery
Timepoint [4] 0 0
Week 56
Secondary outcome [5] 0 0
Systemic corticosteroid (SCS) use
Timepoint [5] 0 0
Week 56
Secondary outcome [6] 0 0
Symptoms associated with CRSwNP
Timepoint [6] 0 0
Week 56

Eligibility
Key inclusion criteria
Inclusion criteria:

1. Female or male patients aged 18 to 75 years inclusive
2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Any nasal and/or sinus surgery within 3 months prior to enrolment
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
Accrual to date
Final
296
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Herston
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Spearwood
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6163 - Spearwood
Recruitment outside Australia
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United States of America
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California
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Colorado
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Kentucky
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Maryland
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New York
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Oklahoma
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Pennsylvania
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Texas
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Utah
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad de Buenos Aire
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Argentina
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San Fernando
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Belgium
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Bruxelles
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Belgium
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Gent
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Leuven
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Plovdiv
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Sofia
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Chile
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Quillota
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Chile
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Santiago
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Chile
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Talca
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China
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Beijing
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China
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Changchun
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China
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Changsha
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Chengdu
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China
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Chongqing
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Foshan
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Guangzhou
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Hangzhou
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Jinan
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Nanchang
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Nanning
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Qingdao
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Urumqi
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Xian
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Yantai
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France
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Marseille
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France
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Toulouse CEDEX 09
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Hungary
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Budapest
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Hungary
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Gyor
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Meguro-ku
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Osaka-shi
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Shinjuku-ku
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Yoshida-gun
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Poland
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Bydgoszcz
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Elblag
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Kraków
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Lublin
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Nadarzyn
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Poznan
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Wroclaw
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Lodz
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Russian Federation
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Izhevsk
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Russian Federation
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Penza
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Russian Federation
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Saint-Petersburg
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Taipei City
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Taipei
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Thailand
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Bangkok
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Phitsanulok
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Turkey
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Aydin
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Bakirkoy
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Izmir
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Malatya
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04157335
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Luo Zhang, Prof. Dr.
Address 0 0
Beijing Tongren Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04157335