A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Asthma Clinical Trial

— MELTEMI  

Official title:

A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808819
• Other study ID #: D3250C00037
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2016
• Est. completion date: June 18, 2020

Study information

• Verified date: March 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).

Description:

This is an open-label safety extension study designed to evaluate the safety and tolerability of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) in severe asthma patients on inhaled corticosteroid and long-acting β2 agonist (ICS-LABA) therapy with or without chronic oral corticosteroids (OCS) and/or other asthma controllers. All patients will receive active drug on the same dosing regimen they received in BORA (NCT02258542). In order to protect the blind of BORA, patients will remain blinded to treatment regimen allocation until they have completed all end of treatment (EOT) assessments in BORA and signed informed consent for participation in this study, after which treatment allocation will be unblinded to both the investigator and the patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Benralizumab
Benralizumab administered subcutaneously every 4 weeks
• Benralizumab
Benralizumab administered subcutaneously every 8 weeks

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aire
Argentina	Research Site	La Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Mendoza
Australia	Research Site	Frankston
Australia	Research Site	Nedlands
Australia	Research Site	Parkville
Australia	Research Site	Randwick
Australia	Research Site	Woolloongabba
Bulgaria	Research Site	Pazardzhik
Bulgaria	Research Site	Pernik
Bulgaria	Research Site	Petrich
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sliven
Bulgaria	Research Site	Vratsa
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Sherwood Park	Alberta
Canada	Research Site	Vancouver	British Columbia
Chile	Research Site	Quillota
Chile	Research Site	Talcahuano
Chile	Research Site	Valparaiso
Czechia	Research Site	Karlovy Vary
Czechia	Research Site	Plzen
Czechia	Research Site	Praha
Czechia	Research Site	Rokycany
France	Research Site	Brest Cedex 2
France	Research Site	Dijon Cedex
France	Research Site	Le Kremlin Bicêtre
France	Research Site	Le Mans Cedex
France	Research Site	Lyon Cedex 04
France	Research Site	Marseille Cedex 20
France	Research Site	Montpellier
France	Research Site	Paris
France	Research Site	Pringy Cedex
France	Research Site	Saint Pierre
France	Research Site	Strasbourg Cedex
France	Research Site	Toulouse Cedex 9
Germany	Research Site	Aschaffenburg
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Frankfurt
Germany	Research Site	Frankfurt/Main
Germany	Research Site	Geesthacht
Germany	Research Site	Grosshansdorf
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Mainz
Germany	Research Site	Marburg
Germany	Research Site	Rüdersdorf
Poland	Research Site	Aleksandrów Lódzki
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Dobre Miasto
Poland	Research Site	Gdansk
Poland	Research Site	Gorzów Wlkp
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Koscian
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Lódz
Poland	Research Site	Lubin
Poland	Research Site	Lublin
Poland	Research Site	Ostrów Wielkopolski
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Proszowice
Poland	Research Site	Ruda Slaska
Poland	Research Site	Rzeszów
Poland	Research Site	Skierniewice
Poland	Research Site	Sosnowiec
Poland	Research Site	Tarnów
Poland	Research Site	Trzebnica
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wielun
Poland	Research Site	Wolomin
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Znin
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Vladikavkaz
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Yekaterinburg
Spain	Research Site	Málaga
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Sagunto(Valencia)
Spain	Research Site	Salamanca
Spain	Research Site	Valencia
Spain	Research Site	Valencia
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Bursa
Turkey	Research Site	Istanbul
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Ivano-Frankivsk
Ukraine	Research Site	Kharkiv Region
Ukraine	Research Site	Kharkiv Region
Ukraine	Research Site	Kharkiv Region
Ukraine	Research Site	Kharkiv Region
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lutsk
Ukraine	Research Site	Vinnytsia
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Chertsey
United Kingdom	Research Site	Cottingham
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Stevenage
United States	Research Site	Abingdon	Virginia
United States	Research Site	Bakersfield	California
United States	Research Site	Bangor	Maine
United States	Research Site	Bronx	New York
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Doral	Florida
United States	Research Site	Durham	North Carolina
United States	Research Site	Falls Church	Virginia
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Flint	Michigan
United States	Research Site	Glendale	Arizona
United States	Research Site	Hialeah	Florida
United States	Research Site	Hodges	South Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jefferson Hills	Pennsylvania
United States	Research Site	Madison	Wisconsin
United States	Research Site	McKinney	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Middleburg Heights	Ohio
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Quincy	Massachusetts
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Redondo Beach	California
United States	Research Site	Roseville	California
United States	Research Site	Sacramento	California
United States	Research Site	San Jose	California
United States	Research Site	Scottsboro	Alabama
United States	Research Site	Stockton	California
United States	Research Site	Traverse City	Michigan
United States	Research Site	Westminster	California
United States	Research Site	Wheat Ridge	Colorado
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida
United States	Research Site	Woodland	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Chile,  Czechia,  France,  Germany,  Poland,  Russian Federation,  Spain,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Basophils, Full Analysis Set	Change from baseline in hematologic lab parameter of Basophils.	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	Change From Baseline in Leukocytes, Full Analysis Set	Change from baseline in hematologic lab parameter of Leukocytes.	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	Change From Baseline in Lymphocytes, Full Analysis Set	Change from baseline in hematologic lab parameter of Lymphocytes.	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	Change From Baseline in Neutrophils, Full Analysis Set	Change from baseline in hematologic lab parameter of Neutrophils.	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	Change From Baseline in Monocytes, Full Analysis Set	Change from baseline in hematologic lab parameter of Monocytes.	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	Change From Baseline in Platelets, Full Analysis Set	Change from baseline in hematologic lab parameter of Platelets.	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	Change From Baseline in Hematocrit, Full Analysis Set	Change from baseline in hematologic lab parameter of Hematocrit.	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	Change From Baseline in Erythrocytes, Full Analysis Set	Change from baseline in hematologic lab parameter of Erythrocytes.	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	Change From Baseline in Hemoglobin, Full Analysis Set	Change from baseline in hematologic lab parameter of Hemoglobin.	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	Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set	Change from baseline in chemistry test ALT.	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	Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set	Change from baseline in chemistry test AST.	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	Change From Baseline in Bilirubin, Full Analysis Set	Change from baseline in chemistry test Bilirubin.	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	Number of Participants With Asthma Exacerbations During Study Period	Asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit	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	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	Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma	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	Change of Blood Eosinophils Count	Change from Baseline to End of Treatment in blood eosinophils count.	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	Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study	Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study	From week 0 to week 184 in study treatment period and plus 12 weeks follow up period
Secondary	Duration of Exposure	Duration of exposure	From week 0 to week 184 in study treatment period

External Links

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