Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
Open-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 11 visits
- Time periods mentioned: 28 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "The study is a total of 11 study visits in a 44 week time period."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility 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: * 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
Study sites (1)
CO
- National Jewish Health · Denver, CO 80206Michael Wechsler, MD · Study contact · 303-398-1085 · wechslerm@njhealth.orgMore trials in Denver