- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652376
Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Marek Lommatzsch, MD
- Phone Number: 7461 +49-381-494-0
- Email: marek.lommatzsch@med.uni-rostock.de
Study Contact Backup
- Name: Johann C. Virchow, MD
- Phone Number: 7461 +49-381-494-0
- Email: j.c.virchow@med.uni-rostock.de
Study Locations
-
-
Mecklenburg-Vorpommern
-
Rostock, Mecklenburg-Vorpommern, Germany, 18057
- University of Rostock
-
Contact:
- Marek Lommatzsch, Prof.
- Phone Number: 7461 +49-381-494-0
- Email: marek.lommatzsch@med.uni-rostock.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 and 75 years
- Patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.
- Documented reversibility of airway obstruction (FEV1 increase ≥ 200 ml and ≥ 15 % after inhalation of a short-acting beta agonist) or bronchial hyperresponsiveness to methacholine or histamine
- Documented concentration of blood eosinophils ≥ 300 / µl blood on the day of study inclusion or in the previous 4 weeks before study inclusion
- Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months at Visit 1.
- Disease history: asthma exacerbations while on ICS plus another controller.
- ACQ-6 score ≥ 1.5 at Visit 1.
- Weight of ≥ 40 kg.
- Screening pre-bronchodilator (pre-BD) FEV1 of < 80% predicted
- Women of childbearing potential (WOCBP)(Definition: WOCBP are those women who have not been surgically sterilized or have not been free from menses for > 2 years) and male study participants have to use adequate contraception methods.
Exclusion Criteria:
- Smoking history of > 10 Pack years
- Current smoking
- Presence of other chronic pulmonary diseases including COPD
- Presence of other chronic inflammatory diseases
- Treatment with any systemic immunosuppressive drug including prednisolone or biologics
- Current pregnancy, breast feeding
- Known helminth infections
- Acute upper or lower respiratory infections within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
Any disorder, including, but not limited to, cardiovascular, gastrontestinal, hepatic, renal, neurological, musculosceletal, 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 studies or their interpretations
- impede the patient´s ability to complete the entire duration of study
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC.
- 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.
- Any clinically significant abnormal findings in physical examination, vital signs, hematology, or clinical chemistry during screening period, which in the opinion of the investigator may put the patient at risk 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.
- Any clinically significant cardiac disease or any electrocardiogram (ECG) abnormality which in the opinion of the Investigator may put the the patient at risk or interfere with study assessments.
- A history of known immunodeficiency disorder including a positive human immunodeciency virus (HIV) test.
- Current malignancy, or history of malignancy, except for: Patients who have had non-melanoma skin cancer 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 is 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 is obtained.
Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of Visit 1). Acceptable washout periods or other asthma biologics:
- Other eosinophil lowering products indicated for asthma (including reslizumab or mepolizumab): at least 4 months.
- Prior omalizumab use: 1 month.
- Any immunosuppressant systemic medication (including systemic glucocorticoids) or treatment with antibodies targeting the immune system.
- Receipt of any investigational medication as part of a research study within approximately 5 half-lives prior to randomization
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > 3 times of the upper limit of normal (ULN) confirmed during screening period.
- Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
- Receipt of live attenuated vaccines 30 days prior to the date of randomization; other types of vaccines are allowed.
- Planned surgical procedures during the conduct of the study.
- Concurrent enrolment in another interventional or post-authorization safety study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Benralizumab
Patients will be treated with Benralizumab 30 mg s.c.
every 4 weeks (three times).
|
Treatment with Benralizumab 30 mg s.c.
every 4 weeks (three times)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dendritic cell concentrations and phenotypes
Time Frame: 5 months
|
Dendritic cell concentrations and phenotypes
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
T-cell concentrations and phenotypes
Time Frame: 5 months
|
T-cell concentrations and phenotypes
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marek Lommatzsch, MD, University of Rostock
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Leukocyte Disorders
- Eosinophilia
- Hypereosinophilic Syndrome
- Asthma
- Pulmonary Eosinophilia
- Anti-Asthmatic Agents
- Respiratory System Agents
- Benralizumab
Other Study ID Numbers
- Rostock-Benralizumab-2018-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe Eosinophilic Asthma
-
AstraZenecaCompletedSevere Eosinophilic AsthmaSpain
-
Lithuanian University of Health SciencesRecruitingAllergic Asthma | Severe Eosinophilic AsthmaLithuania
-
McMaster UniversitySt. Joseph's Healthcare Hamilton; AstraZenecaCompletedSevere Prednisone Dependent Eosinophilic AsthmaCanada
-
AstraZenecaRecruiting
-
AstraZenecaActive, not recruitingSevere Eosinophilic AsthmaCanada
-
AstraZenecaCompletedSevere Eosinophilic AsthmaSwitzerland
-
AstraZenecaCompletedSevere Eosinophilic AsthmaRussian Federation
-
AstraZenecaCompletedAsthma | Severe Eosinophilic AsthmaFrance, Germany, Italy, United Kingdom
-
Attikon HospitalUnknownSevere Eosinophilic Asthma
-
Sotiria General HospitalUnknownSevere Eosinophilic AsthmaGreece
Clinical Trials on Benralizumab
-
AstraZenecaMedImmune LLCCompletedModerate to Very Severe Chronic Obstructive Pulmonary DiseaseUnited States, Denmark, France, Sweden, Thailand, Vietnam, Belgium, Brazil, Peru, Philippines, Turkey, Taiwan, Argentina, Australia, Israel, Poland, Ukraine, Slovenia, Serbia, Mexico, Bulgaria, Colombia, New Zealand, Chile, Norway, Croatia
-
AstraZenecaIqvia Pty LtdTerminatedChronic Spontaneous UrticariaUnited States, Germany, Korea, Republic of, Spain, Bulgaria, Poland, Japan
-
MedImmune LLCCompleted
-
AstraZenecaIqvia Pty LtdTerminatedAtopic DermatitisUnited States, France, Korea, Republic of, Spain, Czechia, Bulgaria, Australia, Poland
-
AstraZenecaMedImmune LLCCompletedModerate to Very Severe Chronic Obstructive Pulmonary DiseaseUnited States, Canada, Germany, Italy, Netherlands, Spain, United Kingdom, Poland, Japan, Austria, Korea, Republic of, Russian Federation, South Africa, Czechia, Hungary, Romania, Switzerland
-
MedImmune LLCMedImmune LtdCompletedAsthmaUnited States, Brazil, Bulgaria, Mexico, Peru, Poland, Russian Federation, Argentina, Canada, Colombia
-
Instituto de Investigación Sanitaria de la Fundación...CompletedAsthma; EosinophilicSpain
-
AstraZenecaCompletedNasal Polyps | Severe Eosinophilic AsthmaUnited States, France, Italy, Spain, Germany, Japan
-
Jonathan A. Bernstein, MDCompletedChronic Idiopathic UrticariaUnited States
-
AstraZenecaCompletedAsthmaUnited States, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom