A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ß2 Agonist

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02808819
• Date of registration: 07/06/2016
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting ß2 Agonist MELTEMI
• 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)
• Date of first enrolment: June 30, 2016
• Target sample size: 447
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02808819
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Biological: Benralizumab

Primary Outcome(s)

Number of subjects with Adverse Events or Serious Adverse Events (AEs/SAEs) [Time Frame: From week 0 to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Shift from baseline to maximum post-baseline in standard chemistry lab parameters [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Shift from baseline to minimum post-baseline in standard chemistry lab parameters [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Shift from baseline to maximum post-baseline in standard hematology lab parameters [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Shift from baseline to minimum post-baseline in standard hematology lab parameters [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Secondary Outcome(s)

Absolute eosinophil counts [Time Frame: Every 16 weeks for the first year and every 24 weeks after first year up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Anti-drug antibodies (ADA) as a measure of immunogenicity [Time Frame: Every 16 weeks for the first year and every 24 weeks after first year up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Number of exacerbations requiring hospitalization [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Number of asthma exacerbations [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Number of exacerbations requiring emergency room visit [Time Frame: Up to week 130 in the study treatment period and through the follow up period (12 weeks after last dose)]

Secondary ID(s)

D3250C00037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors