Actively Recruiting
Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
Led by National Jewish Health · Updated on 2017-09-14
10
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
N
National Jewish Health
Lead Sponsor
T
Teva Pharmaceuticals USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent and comply with study requirements
- Male or female aged over 18 years
- Diagnosed with EGPA for at least 6 months, including asthma and eosinophilia plus at least two additional EGPA features
- Cyclophosphamide induction allowed if last dose was at least 2 weeks (oral) or 3 weeks (IV) prior and WBC 64x10^9/L before visit 1
- Stable dose of methotrexate, azathioprine, or mycophenolate mofetil for at least 4 weeks before visit 1
- Stable oral prednisolone or prednisone dose of 655 mg/day for at least 4 weeks before visit 1
- Stable immunosuppressive therapy dose for at least 4 weeks before visit 1 and during the study (dose reductions allowed for safety)
- Female participants of childbearing potential must commit to effective birth control during the trial
You will not qualify if you...
- Hypereosinophilic Syndrome
- Wegener's Granulomatosis
- Malignancy
- Parasitic disease
- Pregnant or nursing women
- Female participants of childbearing potential with positive pregnancy test or not using effective contraception
- Any other medical illness preventing study participation
- Current or recent (last 3 months) use of reslizumab or other anti-interleukin therapies
- Taking cyclophosphamide
- Known allergy to reslizumab or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
Research Team
M
Michael Wechsler, MD
CONTACT
J
Juno Pak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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