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New treatment option for Asthma
Official title Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
ClinicalTrials.gov ID: NCT02947945
What this study is testing
What is Reslizumab?
Reslizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for asthma.
Also referred to as Cinqair.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed Consent: Able to give written informed consent prior to participation in the study, which will include the ability to comply with the...
- Gender and Age: Male or female people \>18 years old
- EGPA diagnosis: people who have been diagnosed with EGPA for at least 6 months based on the history or presence of: asthma plus eosinophilia...
- A biopsy showing histopathological evidence of eosinophilic vasculitis, or perivascular eosinophilic infiltration, or eosinophil-rich granulomatous...
- Neuropathy, mono or poly (motor deficit or nerve conduction abnormality);
You likely can't join if
- 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...
See the full eligibility 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. people must be...
- Gender and Age: Male or female people \>18 years old
- EGPA diagnosis: people 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...
- 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).
- people 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...
- people 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...
- Female people: 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.