Phase 3 Completed N=446 Other

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

Asthma

Source: ClinicalTrials.gov NCT02808819 ↗

Enrolled (actual)

446

Serious AEs

20.4%

Results posted

Apr 2021

Primary outcomePrimary: Change From Baseline in Basophils, Full Analysis Set — 0.014; 0.012; 0.013 10^9 cells/L

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Basophils, Full Analysis Set	0.014; 0.012; 0.013	—
PRIMARY Change From Baseline in Leukocytes, Full Analysis Set	-0.254; -0.498; -0.377	—
PRIMARY Change From Baseline in Lymphocytes, Full Analysis Set	-0.098; -0.142; -0.121	—
PRIMARY Change From Baseline in Neutrophils, Full Analysis Set	-0.237; -0.392; -0.315	—
PRIMARY Change From Baseline in Monocytes, Full Analysis Set	0.055; 0.056; 0.055	—
PRIMARY Change From Baseline in Platelets, Full Analysis Set	9.1; 11.9; 10.5	—
PRIMARY Change From Baseline in Hematocrit, Full Analysis Set	-0.002; -0.003; -0.003	—
PRIMARY Change From Baseline in Erythrocytes, Full Analysis Set	-0.008; -0.054; -0.031	—
PRIMARY Change From Baseline in Hemoglobin, Full Analysis Set	2.6; 1.2; 1.9	—
PRIMARY Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set	0.007; 0.004; 0.005	—
PRIMARY Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set	-0.021; -0.018; -0.020	—
PRIMARY Change From Baseline in Bilirubin, Full Analysis Set	-0.451; -0.297; -0.374	—
SECONDARY Number of Participants With Asthma Exacerbations During Study Period	96; 97; 193	—
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	25; 28; 53	—
SECONDARY Change of Blood Eosinophils Count	12.3; -12.9; -0.5	—
SECONDARY Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study	19; 28; 47; 11; 17; 28	—
SECONDARY Duration of Exposure	26.35; 25.36; 25.85	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02808819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.