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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

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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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New York
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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Virginia
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Washington
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United States of America
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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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Belgium
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Leuven
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Bulgaria
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Plovdiv
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Bulgaria
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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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China
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Chengdu
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China
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Chongqing
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China
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Foshan
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China
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Guangzhou
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China
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Hangzhou
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China
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Jinan
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China
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Nanchang
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China
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Nanjing
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China
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Nanning
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China
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Qingdao
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China
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Shanghai
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China
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Tianjin
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China
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Urumqi
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China
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Wuhan
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China
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Xi'an
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China
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Xian
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China
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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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Hungary
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Kaposvár
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Hungary
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Siófok
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Hungary
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Székesfehérvár
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Hungary
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Tatabánya
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Italy
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Catanzaro
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Italy
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Pisa
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Italy
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Roma
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Japan
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Chiba-shi
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Fujisawa-shi
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Hiroshima-shi
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Ichikawa-shi
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Iida-shi
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Kawasaki-shi
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Kumamoto-shi
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Meguro-ku
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Minato-ku
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Moriguchi-shi
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Nagaoka-shi
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Osaka-shi
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Japan
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Shinjuku-ku
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Japan
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Yoshida-gun
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Kraków
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Lublin
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Nadarzyn
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Poland
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Poznan
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Poland
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Wroclaw
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Poland
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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
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Saint-Petersburg
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
Country [86] 0 0
Thailand
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Khon Kaen
Country [87] 0 0
Thailand
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Phitsanulok
Country [88] 0 0
Turkey
State/province [88] 0 0
Aydin
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Turkey
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Bakirkoy
Country [90] 0 0
Turkey
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Izmir
Country [91] 0 0
Turkey
State/province [91] 0 0
Malatya
Country [92] 0 0
Vietnam
State/province [92] 0 0
Hanoi
Country [93] 0 0
Vietnam
State/province [93] 0 0
Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04157335