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

NCT ID: NCT02808819

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-06-18

Brief 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).

Detailed 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.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Benralizumab Arm A

Benralizumab administered subcutaneously every 4 weeks

Group Type: OTHER

Benralizumab

Intervention Type: BIOLOGICAL

Benralizumab administered subcutaneously every 4 weeks

Benralizumab Arm B

Benralizumab administered subcutaneously every 8 weeks

Group Type: OTHER

Benralizumab

Intervention Type: BIOLOGICAL

Benralizumab administered subcutaneously every 8 weeks

Interventions

Benralizumab

Benralizumab administered subcutaneously every 4 weeks

Intervention Type: BIOLOGICAL

Benralizumab

Benralizumab administered subcutaneously every 8 weeks

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Scottsboro, Alabama, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Bakersfield, California, United States

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Newport Beach, California, United States

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Redondo Beach, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Jose, California, United States

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Stockton, California, United States

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Westminster, California, United States

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Woodland, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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New Haven, Connecticut, United States

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Clearwater, Florida, United States

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Doral, Florida, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Iowa City, Iowa, United States

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Bangor, Maine, United States

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Quincy, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Flint, Michigan, United States

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Traverse City, Michigan, United States

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New York, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Middleburg Heights, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Jefferson Hills, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Hodges, South Carolina, United States

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Rapid City, South Dakota, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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Abingdon, Virginia, United States

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Falls Church, Virginia, United States

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Madison, Wisconsin, United States

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Buenos Aires, , Argentina

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Ciudad de Buenos Aire, , Argentina

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La Plata, , Argentina

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Mendoza, , Argentina

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Mendoza, , Argentina

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Frankston, , Australia

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Nedlands, , Australia

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Parkville, , Australia

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Randwick, , Australia

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Woolloongabba, , Australia

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Pazardzhik, , Bulgaria

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Pernik, , Bulgaria

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Petrich, , Bulgaria

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Rousse, , Bulgaria

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Sliven, , Bulgaria

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Vratsa, , Bulgaria

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Calgary, Alberta, Canada

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Sherwood Park, Alberta, Canada

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Vancouver, British Columbia, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Quillota, , Chile

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Talcahuano, , Chile

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Valparaíso, , Chile

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Karlovy Vary, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Rokycany, , Czechia

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Brest, , France

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Dijon, , France

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Le Kremlin-Bicêtre, , France

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Le Mans, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Pringy, , France

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Saint-Pierre, , France

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Strasbourg, , France

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Toulouse, , France

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Aschaffenburg, , Germany

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Bamberg, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Frankfurt am Main, , Germany

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Geesthacht, , Germany

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Großhansdorf, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Marburg, , Germany

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Rüdersdorf, , Germany

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Aleksandrów Łódzki, , Poland

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Dobre Miasto, , Poland

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Gdansk, , Poland

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Gorzów Wlkp, , Poland

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Grodzisk Mazowiecki, , Poland

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Kościan, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lubin, , Poland

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Lublin, , Poland

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Ostrów Wielkopolski, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Proszowice, , Poland

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Ruda Śląska, , Poland

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Rzeszów, , Poland

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Skierniewice, , Poland

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Sosnowiec, , Poland

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Tarnów, , Poland

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Trzebnica, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wieluń, , Poland

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Wołomin, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Żnin, , Poland

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Vladikavkaz, , Russia

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Volgograd, , Russia

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Volgograd, , Russia

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Yekaterinburg, , Russia

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Yekaterinburg, , Russia

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Sagunto(Valencia), , Spain

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Salamanca, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv Region, , Ukraine

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Kharkiv Region, , Ukraine

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Kharkiv Region, , Ukraine

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Kharkiv Region, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lutsk, , Ukraine

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Vinnytsia, , Ukraine

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Birmingham, , United Kingdom

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Cambridge, , United Kingdom

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Chertsey, , United Kingdom

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Cottingham, , United Kingdom

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Nottingham, , United Kingdom

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Stevenage, , United Kingdom

Countries

United States; Argentina; Australia; Bulgaria; Canada; Chile; Czechia; France; Germany; Poland; Russia; Spain; Turkey (Türkiye); Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250C00037&attachmentIdentifier=c52ffe9a-53b4-40d3-935b-1b8ecf80bc07&fileName=d3250c00037-revised-csp-2-redacted.pdf&versionIdentifier=

CSP redacted.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250C00037&attachmentIdentifier=d7b2554d-b014-4ffa-adec-c930fc06f4f5&fileName=d3250c00037-sap-ed-2-redacted.pdf&versionIdentifier=

SAP redacted.

Other Identifiers

D3250C00037

Identifier Type: -

Identifier Source: org_study_id