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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02808819




Registration number
NCT02808819
Ethics application status
Date submitted
7/06/2016
Date registered
22/06/2016

Titles & IDs
Public title
A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ß2 Agonist
Scientific title
A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ß2 Agonist (MELTEMI)
Secondary ID [1] 0 0
D3250C00037
Universal Trial Number (UTN)
Trial acronym
MELTEMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

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

Other: Benralizumab Arm A - Benralizumab administered subcutaneously every 4 weeks

Other: Benralizumab Arm B - Benralizumab administered subcutaneously every 8 weeks


Treatment: Other: Benralizumab
Benralizumab administered subcutaneously every 4 weeks

Treatment: Other: Benralizumab
Benralizumab administered subcutaneously every 8 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Basophils, Full Analysis Set
Timepoint [1] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [2] 0 0
Change From Baseline in Leukocytes, Full Analysis Set
Timepoint [2] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [3] 0 0
Change From Baseline in Lymphocytes, Full Analysis Set
Timepoint [3] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [4] 0 0
Change From Baseline in Neutrophils, Full Analysis Set
Timepoint [4] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [5] 0 0
Change From Baseline in Monocytes, Full Analysis Set
Timepoint [5] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [6] 0 0
Change From Baseline in Platelets, Full Analysis Set
Timepoint [6] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [7] 0 0
Change From Baseline in Hematocrit, Full Analysis Set
Timepoint [7] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [8] 0 0
Change From Baseline in Erythrocytes, Full Analysis Set
Timepoint [8] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [9] 0 0
Change From Baseline in Hemoglobin, Full Analysis Set
Timepoint [9] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [10] 0 0
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
Timepoint [10] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [11] 0 0
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set
Timepoint [11] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Primary outcome [12] 0 0
Change From Baseline in Bilirubin, Full Analysis Set
Timepoint [12] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Secondary outcome [1] 0 0
Number of Participants With Asthma Exacerbations During Study Period
Timepoint [1] 0 0
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented.
Secondary outcome [2] 0 0
Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Timepoint [2] 0 0
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented.
Secondary outcome [3] 0 0
Change of Blood Eosinophils Count
Timepoint [3] 0 0
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Secondary outcome [4] 0 0
Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study
Timepoint [4] 0 0
From week 0 to week 184 in study treatment period and plus 12 weeks follow up period
Secondary outcome [5] 0 0
Duration of Exposure
Timepoint [5] 0 0
From week 0 to week 184 in study treatment period

Eligibility
Key inclusion criteria
* Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
* Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
* Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
* For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
* All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:

* Affect the safety of the patient throughout the study
* Influence the findings of the study or their interpretations
* Impede the patient's ability to complete the entire duration of study
* A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy
* Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient's ability to complete the entire duration of the study
* Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
* Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP
* Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
* Planned major surgical procedures during the conduct of the study
* Previous participation in the present study
* Concurrent enrolment in another drug-related interventional clinical trial
* AstraZeneca staff involved in the planning and/or conduct of the study
* Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
* Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
* Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2020
Sample size
Target
Accrual to date
Final
447
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Frankston
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment hospital [3] 0 0
Research Site - Parkville
Recruitment hospital [4] 0 0
Research Site - Randwick
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Iowa
Country [8] 0 0
United States of America
State/province [8] 0 0
Maine
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
South Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Ciudad de Buenos Aire
Country [23] 0 0
Argentina
State/province [23] 0 0
La Plata
Country [24] 0 0
Argentina
State/province [24] 0 0
Mendoza
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Pazardzhik
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Pernik
Country [27] 0 0
Bulgaria
State/province [27] 0 0
Petrich
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Ruse
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Sliven
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Vratsa
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Chile
State/province [35] 0 0
Quillota
Country [36] 0 0
Chile
State/province [36] 0 0
Talcahuano
Country [37] 0 0
Chile
State/province [37] 0 0
Valparaiso
Country [38] 0 0
Czechia
State/province [38] 0 0
Karlovy Vary
Country [39] 0 0
Czechia
State/province [39] 0 0
Plzen
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha
Country [41] 0 0
Czechia
State/province [41] 0 0
Rokycany
Country [42] 0 0
France
State/province [42] 0 0
Brest Cedex 2
Country [43] 0 0
France
State/province [43] 0 0
Dijon Cedex
Country [44] 0 0
France
State/province [44] 0 0
Le Kremlin Bicêtre
Country [45] 0 0
France
State/province [45] 0 0
Le Mans Cedex
Country [46] 0 0
France
State/province [46] 0 0
Lyon Cedex 04
Country [47] 0 0
France
State/province [47] 0 0
Marseille Cedex 20
Country [48] 0 0
France
State/province [48] 0 0
Montpellier
Country [49] 0 0
France
State/province [49] 0 0
Paris
Country [50] 0 0
France
State/province [50] 0 0
Pringy Cedex
Country [51] 0 0
France
State/province [51] 0 0
Saint Pierre
Country [52] 0 0
France
State/province [52] 0 0
Strasbourg Cedex
Country [53] 0 0
France
State/province [53] 0 0
Toulouse Cedex 9
Country [54] 0 0
Germany
State/province [54] 0 0
Aschaffenburg
Country [55] 0 0
Germany
State/province [55] 0 0
Bamberg
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Frankfurt/Main
Country [58] 0 0
Germany
State/province [58] 0 0
Frankfurt
Country [59] 0 0
Germany
State/province [59] 0 0
Geesthacht
Country [60] 0 0
Germany
State/province [60] 0 0
Grosshansdorf
Country [61] 0 0
Germany
State/province [61] 0 0
Hamburg
Country [62] 0 0
Germany
State/province [62] 0 0
Hannover
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Germany
State/province [65] 0 0
Marburg
Country [66] 0 0
Germany
State/province [66] 0 0
Rüdersdorf
Country [67] 0 0
Poland
State/province [67] 0 0
Aleksandrów Lódzki
Country [68] 0 0
Poland
State/province [68] 0 0
Bialystok
Country [69] 0 0
Poland
State/province [69] 0 0
Bydgoszcz
Country [70] 0 0
Poland
State/province [70] 0 0
Dobre Miasto
Country [71] 0 0
Poland
State/province [71] 0 0
Gdansk
Country [72] 0 0
Poland
State/province [72] 0 0
Gorzów Wlkp
Country [73] 0 0
Poland
State/province [73] 0 0
Grodzisk Mazowiecki
Country [74] 0 0
Poland
State/province [74] 0 0
Koscian
Country [75] 0 0
Poland
State/province [75] 0 0
Kraków
Country [76] 0 0
Poland
State/province [76] 0 0
Lubin
Country [77] 0 0
Poland
State/province [77] 0 0
Lublin
Country [78] 0 0
Poland
State/province [78] 0 0
Ostrów Wielkopolski
Country [79] 0 0
Poland
State/province [79] 0 0
Poznan
Country [80] 0 0
Poland
State/province [80] 0 0
Proszowice
Country [81] 0 0
Poland
State/province [81] 0 0
Ruda Slaska
Country [82] 0 0
Poland
State/province [82] 0 0
Rzeszów
Country [83] 0 0
Poland
State/province [83] 0 0
Skierniewice
Country [84] 0 0
Poland
State/province [84] 0 0
Sosnowiec
Country [85] 0 0
Poland
State/province [85] 0 0
Tarnów
Country [86] 0 0
Poland
State/province [86] 0 0
Trzebnica
Country [87] 0 0
Poland
State/province [87] 0 0
Warszawa
Country [88] 0 0
Poland
State/province [88] 0 0
Wielun
Country [89] 0 0
Poland
State/province [89] 0 0
Wolomin
Country [90] 0 0
Poland
State/province [90] 0 0
Wroclaw
Country [91] 0 0
Poland
State/province [91] 0 0
Lódz
Country [92] 0 0
Poland
State/province [92] 0 0
Znin
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Ekaterinburg
Country [94] 0 0
Russian Federation
State/province [94] 0 0
Nizhny Novgorod
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Saratov
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Smolensk
Country [97] 0 0
Russian Federation
State/province [97] 0 0
St. Petersburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Vladikavkaz
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Volgograd
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Yekaterinburg
Country [101] 0 0
Spain
State/province [101] 0 0
Málaga
Country [102] 0 0
Spain
State/province [102] 0 0
Palma de Mallorca
Country [103] 0 0
Spain
State/province [103] 0 0
Sagunto(Valencia)
Country [104] 0 0
Spain
State/province [104] 0 0
Salamanca
Country [105] 0 0
Spain
State/province [105] 0 0
Valencia
Country [106] 0 0
Turkey
State/province [106] 0 0
Adana
Country [107] 0 0
Turkey
State/province [107] 0 0
Ankara
Country [108] 0 0
Turkey
State/province [108] 0 0
Bursa
Country [109] 0 0
Turkey
State/province [109] 0 0
Istanbul
Country [110] 0 0
Ukraine
State/province [110] 0 0
Dnipro
Country [111] 0 0
Ukraine
State/province [111] 0 0
Ivano-Frankivsk
Country [112] 0 0
Ukraine
State/province [112] 0 0
Kharkiv Region
Country [113] 0 0
Ukraine
State/province [113] 0 0
Kyiv
Country [114] 0 0
Ukraine
State/province [114] 0 0
Lutsk
Country [115] 0 0
Ukraine
State/province [115] 0 0
Vinnytsia
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Birmingham
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Cambridge
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Chertsey
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Cottingham
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Nottingham
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Stevenage

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
Address 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02808819