Severe Eosinophilic AsthmaPhase 4NCT03652376
Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma
A Phase 4 study testing Benralizumab in people with Severe Eosinophilic Asthma, run by University of Rostock at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Eosinophilic Asthma
- What is being tested?
- Benralizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057
Marek Lommatzsch, Prof., +49-381-494-0 ext. 7461, marek.lommatzsch@med.uni-rostock.de
About this study
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.
Read the detailed description
Phase III clinical trials demonstrated that benralizumab treatment results in a significant decrease in exacerbations and a significant increase in lung function and quality of life in patients with severe eosinophilic asthma. However, the precise underlying mechanisms leading to this clinical benefit of benralizumab treatment are not completely understood. Dendritic cells are key regulators of the adaptive and innate immune system. There is evidence that eosinophils have a direct influence on the function of dendritic cells. In addition, there are multiple indirect interactions between eosinophils and dendritic cells in asthma. However, there is currently no information on the impact of benralizumab treatment and a complete removal of circulating eosinophils on the number and phenotype of human dendritic cells. Benralizumab is chosen for this study because it is the only anti-IL-5 biologic which results in a complete removal of eosinophils from peripheral blood.
- Conditions
- Severe Eosinophilic Asthma
- Being tested
- Benralizumab
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenralizumabDrug
Treatment with Benralizumab 30 mg s.c. every 4 weeks (three times)
| Study group | Role | What they receive |
|---|---|---|
| Benralizumab | Experimental | Patients will be treated with Benralizumab 30 mg s.c. every 4 weeks (three times). Receives: Drug: Benralizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dendritic cell concentrations and phenotypes
Dendritic cell concentrations and phenotypes
Measured: 5 months
Secondary outcomes (1)
T-cell concentrations and phenotypes
T-cell concentrations and phenotypes
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Eosinophilic AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Lommatzsch, University of Rostock
- Investigators
- Marek Lommatzsch, MD, Principal investigator, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652376
- Sponsor's protocol ID
- Rostock-Benralizumab-2018-1
- Status last verified
- Aug 2018
- First submitted
- 26 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32762056
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma
- ClinicalTrials.gov ID
- NCT03652376
- Acronym / sponsor ID
- Rostock-Benralizumab-2018-1
- Conditions
- Severe Eosinophilic Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase III clinical trials demonstrated that benralizumab treatment results in a significant decrease in exacerbations and a significant increase in lung function and quality of life in patients with severe eosinophilic asthma. However, the precise underlying mechanisms leading to this clinical benefit of benralizumab treatment are not completely understood. Dendritic cells are key regulators of the adaptive and innate immune system. There is evidence that eosinophils have a direct influence on the function of dendritic cells. In addition, there are multiple indirect interactions between eosinophils and dendritic cells in asthma. However, there is currently no information on the impact of benralizumab treatment and a complete removal of circulating eosinophils on the number and phenotype of human dendritic cells. Benralizumab is chosen for this study because it is the only anti-IL-5 biologic which results in a complete removal of eosinophils from peripheral blood.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Benralizumab | Experimental | Drug: BenralizumabPatients will be treated with Benralizumab 30 mg s.c. every 4 weeks (three times). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenralizumabTreatment with Benralizumab 30 mg s.c. every 4 weeks (three times) | Drug | Benralizumab |
Primary outcome
Dendritic cell concentrations and phenotypes
Time frame: 5 months
Dendritic cell concentrations and phenotypes
1 secondary outcome
T-cell concentrations and phenotypes
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Derived from this study: PubMed 32762056Lommatzsch 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.
- Individual participant dataSharing planned: No
Related trials for Severe Eosinophilic Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
RecruitingPhase 2
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Eosinophilic Asthma
Active, not recruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Asthma
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
Allergic Bronchopulmonary Aspergillosis, ABPA
RecruitingObservational study
A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
Severe Eosinophilic Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Lommatzsch, MD principal investigator
University of Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benralizumab in people with Severe Eosinophilic Asthma, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Lommatzsch, MD (+49-381-494-0 ext. 7461, marek.lommatzsch@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dendritic cell concentrations and phenotypes (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03652376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.