Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
Reslizumab is a type of medicine called a monoclonal antibody that is made in the research
 clinic; it works by blocking a specific protein in the body called interleukin-5. The study
 medicine, reslizumab, is not yet approved for doctors to treat patients with EGPA. It is
 considered an experimental drug in this study.
This study is open-label which means that all subjects will receive the study medication. The
 study medicine - reslizumab - will be given to the participants in addition to the medicines
 they are already taking to treat their EGPA such as oral steroids (e.g. prednisone) and
 medicines that reduce the activity of their immune system (the study doctor will tell the
 participants which medications these are) - this is what is meant by 'standard of care' and
 can vary in different countries. Drugs that are sometimes used (i.e., 'standard of care') to
 reduce the activity of the immune system in EGPA (in addition to oral steroids) include
 azathioprine, methotrexate, mycophenolate mofetil and cyclophosphamide. Information about how
 the study drug affects the human body and health will be collected through a number of tests,
 procedures and questions.

 The study medicine, reslizumab, will be given to the participants at a dose of 3mg/kg
 intravenously (within a vein) every four weeks for 28 weeks for a total of 7 treatments.
 During the treatment phase of this study, a study staff member will call the participants
 every two weeks to see how they are doing, what medications they are taking, and if they are
 able to decrease their steroid use. The study is a total of 11 study visits in a 44 week time
 period. Everyone who takes part in the study will continue to receive his/her existing
 treatments for EGPA (although the dose of oral steroids may be reduced during the study).
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:

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

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

 -  Pulmonary infiltrates, non-fixed;

 -  Sino-nasal abnormality;

 -  Cardiomyopathy (established by echocardiography or MRI);

 -  Glomerulonephritis (haematuria, red cell casts, proteinuria);

 -  Alveolar haemorrhage (by bronchoalveolar lavage);

 -  Palpable purpura;

 -  ANCA positive (MPO or PR3).

 -  Subjects who have received a cyclophosphamide (CYC) induction regimen may be included
 a minimum of 2 weeks after the last dose of daily oral CYC, or 3 weeks after the last
 dose of pulsed IV CYC prior to visit 1, if their total WBC is ≥4x109/L prior to visit
 1.

 -  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 1.

 -  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 1.

 -  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 1 and
 during the study (dose reductions for safety reasons will be permitted).

 -  Female subjects: To be eligible for entry into the study, females of childbearing
 potential (FCBP) must commit to consistent and correct use of an acceptable method of
 birth control beginning with consent, for the duration of the trial.

 Exclusion Criteria:

 -  Hypereosinophilic Syndrome

 -  Wegener's Granulomatosis

 -  Malignancy

 -  Parasitic disease

 -  Pregnant or nursing

 -  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.

 -  Any other medical illness that precludes study involvement

 -  Patients who are currently receiving or have previously received reslizumab or any
 other type of anti-interleukin therapy (i.e. mepolizumab, lebrikizumab etc.) within
 the last three months.

 -  Taking cyclophosphamide

 -  Any patients with a known hypersensitivity to reslizumab or any of its excipients