Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02322775
• Date of registration: 19/12/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
• Scientific title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma.
• Date of first enrolment: February 2, 2015
• Target sample size: 211
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02322775
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Canada, Germany, Hungary, Poland, Slovakia, United States

Contacts

• Name: Gary T. Ferguson, M.D.,P.C.
• Affiliation: Pulmonary Research Institute of Southeast Michigan

Key inclusion & exclusion criteria

Inclusion Criteria:

Written 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 (EU) guidelines.

- Female and male aged 18 to 75 years, inclusively, at the time of Visit 1.

- Weight of =40 kg.

- Evidence of asthma as documented by post-bronchodilator (post-BD) reversibility in
FEV1 of = 12% demonstrated at Visit 2.

- Documented use of 1 of the following types of asthma therapy at time of informed
consent: Low- to medium-dose ICS (ie, 100 to 500 µg fluticasone dry powder formulation
equivalents total daily dose) with or without other controller medications, eg, an
LTRA and/or theophylline or Low-dose ICS/LABA fixed combination therapy (eg, the
lowest regular maintenance dose approved in the local country will meet this
criterion)

- Morning pre-bronchodilator (pre-BD) FEV1 of > 50% to = 90% predicted at Visit 2.

Exclusion Criteria:

- Clinically important pulmonary disease other than asthma (eg, active lung infection,
COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome
associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary
ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other
than asthma, that are associated with elevated peripheral eosinophil counts (eg,
allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome,
hypereosinophilic syndrome).

- 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

- nfluence the findings of the studies or their interpretations,- Impede the patient's
ability to complete the entire duration of study.

- Known history of allergy or reaction to the investigational product formulation.

- History of anaphylaxis to any biologic therapy.- History of Guillain-Barré syndrome.

- A helminth parasitic infection diagnosed within 24 weeks prior to the date informed
consent is obtained that has not been treated with, or has failed to respond to
standard of care therapy.- Acute upper or lower respiratory infections requiring
antibiotics or antiviral medication within 30 days prior to the date informed consent
is obtained or during the screening/run-in period.

- Any clinically significant abnormal findings in physical examination, vital signs,
hematology, clinical chemistry, or urinalysis during screening period, 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 the
patient's ability to complete entire duration of the study.

- Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a
positive medical history for hepatitis B or C. Patients with a history of hepatitis B
vaccination without history of hepatitis B are allowed to enroll.

- A history of known immunodeficiency disorder including a positive human
immunodeficiency virus (HIV) test.

- History of cancer:

- Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the
skin or in situ carcinoma of the cervix are eligible provided that the patient is in
remission and curative therapy was completed at least 12 months prior to the date
informed consent was obtained.

- Patients who have had other malignancies are eligible provided that the patient is in
remission and curative therapy was completed at least 5 years prior to the date
informed consent was obtained



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Biological: Benralizumab

Biological: Placebo

Primary Outcome(s)

Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 [Time Frame: Baseline, Week 4, Week 8 and Week 12]

Secondary Outcome(s)

Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 [Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12]

Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12 [Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12]

Peripheral Blood Eosinophil Levels [Time Frame: Baseline, Week 12 and Week 20]

Change From Baseline in Total Asthma Symptom Score at Week 12 [Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12]

Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12 [Time Frame: Baseline and Week 12]

Asthma Exacerbations [Time Frame: Up to Week 12]

Change From Baseline in Mean ACQ-6 Score at Week 12 [Time Frame: Baseline, Week 4, Week 8 and Week 12]

Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12 [Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12]

Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12 [Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12]

Serum Concentrations (ng/mL) [Time Frame: Baseline, Week 12 and Week 20]

Secondary ID(s)

2014-004427-40

D3250C00032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02322775