Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    20
  • sponsor
    McMaster University
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Updated on 28 January 2021
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Summary

In severe prednisone-dependent eosinophilic asthma, Benralizumab would suppress airway eosinophilia that is not suppressed by either Mepolizumab or Reslizumab and this would be associated with greater asthma control

Description

Benralizumab thus targets 'eosinophil biology', by inhibiting the interleukin (IL-5) receptor signalling, and inducing apoptosis in cells with an IL-5receptor. Hence, for patients who remain 'uncontrolled' on anti-IL-5 therapy (with detectable eosinophil activity and IL5-R+ cells in the airways), the investigators believe would benefit from a strategy that not only reduces eosinophil proliferation/recruitment/maturation, but also depletes cells capable of inducing downstream IL-5 signalling.

Details
Condition Severe Prednisone Dependent Eosinophilic Asthma
Treatment Placebo, benralizumab
Clinical Study IdentifierNCT03470311
SponsorMcMaster University
Last Modified on28 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Severe Prednisone Dependent Eosinophilic Asthma?
Do you have any of these conditions: Do you have Severe Prednisone Dependent Eosinophilic Asthma??
Do you have any of these conditions: Do you have Severe Prednisone Dependent Eosinophilic Asthma??
Do you have any of these conditions: Do you have Severe Prednisone Dependent Eosinophilic Asthma??
Informed consent Prior to the beginning of the study, patients must be willing and fully capable to provide written informed consent
Diagnosed prednisone-dependent eosinophilic asthma
Previous treatment with 100 mg mepolizumab administered subcutaneously Q4W or reslizumab 3 mg/kg IV Q4W for at least 6 months
Sputum eosinophils >3%
ACQ 1.5
Age >18
Male or eligible female subjects
To be eligible for entry into the study, females of childbearing potential
(premenopausal women who are not permanently sterilized by means of
hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) must commit
to consistent and correct use of a highly effective method of birth control
(true sexual abstinence, a vasectomized sexual partner, Implanon, female tubal
occlusion, Intrauterine device (IUD), Depo provera injections, oral
contraceptive pills or Nuvaring) for the duration of the trial and for 3
months after the last study drug administration. A serum pregnancy test is
required of all females at the initial Baseline Visit (Visit 1). In addition
a urine pregnancy test will be performed for all females prior to enrollment
during each scheduled study visit prior to the injection of investigational
product, and during the Follow-up Visit
\. Male subjects who are sexually active must agree to use a double barrier
method of contraception (condom with spermicide) from the first dose of study
drug and for 3 months after the last dose of study drug

Exclusion Criteria

Currently receiving another monoclonal antibody
Intolerance, hypersensitivity, insensitivity or neutralizing antibody to Mepolizumab and/or Reslizumab
Malignancy within the last 5 years
Any co-morbidity that the investigator believes is a contraindication. This includes but is not limited to any respiratory, cardiovascular, gastrointestinal, hematological, neurological, immunological, musculoskeletal, renal, infectious, neoplastic or inflammatory condition that may place the safety of the subject at risk during the duration of the study, influence the results of the study or their interpretation, or prevent the patient from completing the entire duration of the study
Current pregnancy or lactation
Current smoker or ex-smoker with a smoking history greater than 20 pack years
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