Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma

NCT03652376 | Unknown Phase 4 FDA Drug

• 1 other identifier: Rostock-Benralizumab-2018-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of removing eosinophils from peripheral blood (using treatment with Benralizumab, which is approved for the treatment of severe eosoniphilic asthma) on circulating dendritic cells in patients with severe eosinophilic asthma.

Conditions

Severe Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• Dendritic cell concentrations and phenotypes

  Dendritic cell concentrations and phenotypes

  5 months

Secondary Outcomes (1)

• T-cell concentrations and phenotypes

  5 months

Study Arms (1)

Benralizumab

EXPERIMENTAL

Patients will be treated with Benralizumab 30 mg s.c. every 4 weeks (three times).

Drug: Benralizumab

Interventions

Benralizumab DRUG

Treatment with Benralizumab 30 mg s.c. every 4 weeks (three times)

Benralizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rostock: lead

Study Sites (1)

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Related Publications (1)

• Lommatzsch M, Marchewski H, Schwefel G, Stoll P, Virchow JC, Bratke K. Benralizumab strongly reduces blood basophils in severe eosinophilic asthma. Clin Exp Allergy. 2020 Nov;50(11):1267-1269. doi: 10.1111/cea.13720. Epub 2020 Aug 26. No abstract available.

  PMID: 32762056 DERIVED

MeSH Terms

Conditions

Pulmonary Eosinophilia

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Marek Lommatzsch, MD

  University of Rostock

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marek Lommatzsch, MD

CONTACT

+49-381-494-0; marek.lommatzsch@med.uni-rostock.de

Johann C. Virchow, MD

CONTACT

+49-381-494-0; j.c.virchow@med.uni-rostock.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Marek Lommatzsch

Model Details: Patients with severe eosinophilic asthma (n=20) will be treated with benralizumab 3 times every 4 weeks, and the effect of this treatment on dendritic cell concentrations and dendritic cell characteristics will be investigated 4 weeks after the last benralizumab dose and after a follow-up of 3 months. There will be a separate control group of subjects (not a treatment or placebo arm) without asthma not treated with benralizumab (to study dendritic cell concentrations and dendritic cell characteristics in patients without asthma and without benralizumab treatment).

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: August 29, 2018
• Study Start: September 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 31, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)