Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Study identifier:D3250C00018

ClinicalTrials.gov identifier:NCT01914757

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

2508

Study type

Interventional

Age

12 Years - 75 Years

Date

Study Start Date: 01 Aug 2013

Primary Completion Date: 01 Mar 2016

Study Completion Date: 01 Mar 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Female and male aged 12 to 75 years, inclusively, at the time of Visit 1
3. History of physician-diagnosed asthma requiring treatment with medium-to-high
dose ICS (>250µg fluticasone dry powder formulation equivalents total daily dose)
and a LABA, for at least 12 months prior to Visit 1.
4. Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 μg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.

Exclusion Criteria

1. Clinically important pulmonary disease other than asthma (e.g. 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 (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-
Strauss syndrome, hypereosinophilic syndrome)
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic,
renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
haematological, 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 studies or their interpretations
- Impede the patient’s ability to complete the entire duration of study
3. 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
4. Any clinically significant abnormal findings in physical examination, vital signs,
haematology, clinical chemistry, or urinalysis during screening/run-in 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

No locations available

Arms	Assigned Interventions
Experimental: Benralizumab 30 mg q.4 weeks Benralizumab administered subcutaneously every 4 weeks	Biological/Vaccine: Benralizumab Benralizumab subcutaneously on study week 0 until study week 52 inclusive. Other Name: Benralizumab
Experimental: Benralizumab 30 mg q.8 weeks Benralizumab administered subcutaneously every 8 weeks	Biological/Vaccine: Benralizumab Benralizumab subcutaneously on study week 0 until study week 52 inclusive. Other Name: Benralizumab
Placebo Comparator: Placebo Placebo administered subcutaneously	Biological/Vaccine: Placebo Placebo subcutaneously on study week 0 until study week 52 inclusive. Other Name: Placebo

Documents available

D3250C00018CSP3redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AstraZeneca Clinical Study Information

+1 800-236-9933