Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Jewish Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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);
Disqualifiers
Hypereosinophilic Syndrome
Wegener's Granulomatosis
Malignancy
Parasitic disease
Trial design
Design model
Single group
Treatments tested in this trial
Reslizumab
DrugAll subjects will receive Reslizumab
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Open-LabelOther 1 intervention
Trial outcomes
Primary outcomes
1
Document the safety of reslizumab therapy in patients with EGPA
All adverse events will be reported to the sponsor and the IRB in accordance with the policy of National Jewish Health and the FDA. Adverse events will be recorded on Case Report Forms as non-serious or serious events (DAEs). Serious adverse events, whether or not considered related to the investigational drug, will be recorded on the Serious Adverse Event form and faxed to the IRB and the sponsor as soon as site personnel are aware of the event. Every attempt will be made to collect discharge summaries for each hospitalization should they occur to provide further details.
Time frame
up to 12 monthsSecondary outcomes
1
Demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage
Goal is to demonstrate the steroid sparing effect of reslizumab therapy by titrating corticosteroid dosage while using this anti-IL-5 therapy or to reduce the rate of EGPA exacerbations during the study period. Change in steroid dose will be assessed by comparing the corticosteroid dose of subjects at the end of the steroid stable phase and compare to steroid dose at the end of the treatment period. Change in the rate of exacerbations will be assessed by comparing the rate of exacerbations during the study period with the rate during the washout and safety-monitoring period as well as with the self-reported rate of exacerbations from the year prior to the study.
Time frame
up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Jewish Health
Lead sponsor
Teva Pharmaceuticals USA
Collaborator
Source ClinicalTrials.gov