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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03010436
Date of registration: 11/12/2016
Prospective Registration: Yes
Primary sponsor: National Jewish Health
Public title: Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study BITE
Scientific title: The Efficacy and Safety of Benralizumab In the Treatment of Eosinophilic Grandulomatosis With Polyangiitis (EGPA) Study: BITE
Date of first enrolment: April 15, 2017
Target sample size: 10
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03010436
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Mary Gill, RN
Address: 
Telephone: 303-398-1443
Email: gillm@njhealth.org
Affiliation: 
Name:     Michael Wechsler, MD
Address: 
Telephone: 303-398-1443
Email: wechslerm@njhealth.org
Affiliation: 
Name:     Michael Wechsler, MD
Address: 
Telephone:
Email:
Affiliation:  National Jewish Health
Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed Consent: Able to give written informed consent prior to participation in the
study, which will include the ability to comply with the requirements and restrictions
listed in the consent form. Subjects must be able to read, comprehend, and write at a
level sufficient to complete study related materials.

- Gender and Age: Male or female subjects >18 years old

- EGPA diagnosis: subjects who have been diagnosed with EGPA for at least 6 months based
on the history or presence of: asthma plus eosinophilia (>1.0x109/L and/or >10% of
leucocytes) plus at least two of the following additional features of EGPA

1. A biopsy showing histopathological evidence of eosinophilic vasculitis, or
perivascular eosinophilic infiltration, or eosinophil-rich granulomatous
inflammation;

2. Neuropathy, mono or poly (motor deficit or nerve conduction abnormality);

3. Pulmonary infiltrates, non-fixed;

4. Sino-nasal abnormality;

5. Cardiomyopathy (established by echocardiography or MRI);

6. Glomerulonephritis (haematuria, red cell casts, proteinuria);

7. Alveolar haemorrhage (by bronchoalveolar lavage);

8. Palpable purpura;

9. ANCA positive (MPO or PR3).

- Subjects who have received cyclophosphamide can be included after a 4-week washout
prior to visit 0 (first injection).

- Subjects who have received a methotrexate, azathioprine, or mycophenolate mofetil
induction regimen may be included if on a stable dose for at least 4 weeks prior to
visit 0.

- Corticosteroid therapy: Subject must be on a stable dose of oral prednisolone or
prednisone of =5 mg/day for at least 4 weeks prior to visit 0.

- Immunosuppressive therapy: If receiving immunosuppressive therapy (including
methotrexate, azathioprine, or mycophenolate mofetil, but excluding restricted
medications below) the dosage must be stable for the 4 weeks prior to visit 0 and
during the study (dose reductions for safety reasons will be permitted).

- Female subjects: Women of childbearing potential (WOCBP) must use an effective form of
birth control (confirmed by the Investigator). Effective forms of birth control
include: true sexual abstinence, a vasectomized sexual partner, Implanon, female
sterilization by tubal occlusion, any effective IUD intrauterine device/IUS
levonogestrel Intrauterine system, Depo-Provera(tm) injections, oral contraceptive,
and Evra Patch(tm) or Nuvaring(tm). WOCBP must agree to use effective method of birth
control, as defined above, from enrolment, throughout the study duration and within 16
weeks after last dose of IP, and have negative serum pregnancy test result on Visit 0.

- Women not of childbearing potential are defined as women who are either permanently
sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who
are postmenopausal. Women will be considered postmenopausal if they have been
amenorrheic for 12 months prior to the planned date of visit -1 without an alternative
medical cause. The following age-specific requirements apply:

- Women <50 years old would be considered postmenopausal if they have been amenorrheic
for 12 months or more following cessation of exogenous hormonal treatment and follicle
stimulating hormone (FSH) levels in the postmenopausal range.

- Women =50 years old would be considered postmenopausal if they have been amenorrheic
for 12 months or more following cessation of all exogenous hormonal treatment.

- All male subjects who are sexually active must agree to use an acceptable method of
contraception (condom with or without spermicide, vasectomy) from Visit 0 until 16
weeks after their last dose.

Exclusion Criteria:

- Hypereosinophilic Syndrome

- Wegener's Granulomatosis

- History of cancer: Subjects who have had basal cell carcinoma, localized squamous cell
carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that
the subject is in remission and curative therapy was completed at least 12 months
prior to the date informed consent, and assent when applicable was obtained. Subjects
who have had other malignancies are eligible provided that the subject is in remission
and curative therapy was completed at least 5 years prior to the date informed
consent, and assent when applicable, was obtained.

- 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.

- Pregnant or nursing

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =2.5 times
the upper limit of normal (ULN) confirmed during screening period.

- If female and of child-bearing potential, must have negative pregnancy test and must
adhere to acceptable method of contraception (with <1% failure rate) during the study
and for four months after the study.

- Receipt of any investigational non biologic within 30 days or 5 half-lives prior to
visit 0, whichever is longer.

- A history of known immunodeficiency disorder including a positive human
immunodeficiency virus (HIV) test.

- Any other medical illness that precludes study involvement

- Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a
positive medical history for hepatitis B or C. Subjects with a history of hepatitis B
vaccination without history of hepatitis B are allowed to be enrolled.

- Patients who are currently receiving or have previously received benralizumab or any
other type of anti-interleukin therapy (i.e. mepolizumab, reslizumab, lebrikizumab
etc.) within the last 4 months or 5 half-lives whichever is longer.

- History of anaphylaxis to any biologic therapy or vaccine.

- Receipt of immunoglobulin or blood products within 30 days prior to the date informed
consent is obtained.

- Taking cyclophosphamide



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All
Health Condition(s) or Problem(s) studied
Asthma
Intervention(s)
Drug: Benralizumab
Primary Outcome(s)
All adverse events will be reported by count of events (safety and tolerability ) [Time Frame: Up to 12 months]
Secondary Outcome(s)
Change in corticosteroid dosage [Time Frame: Up to 12 months]
Change in the rate of EGPA exacerbations during the study period. [Time Frame: Up to 12 months]
Secondary ID(s)
HS-3010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
AstraZeneca
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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