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Monoclonal Antibodies
Nucala (mepolizumab) for Angioedema
Phase 2
Waitlist Available
Led By Paneez Khoury, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The subject is male or female, aged 18 years or older.
The subject has a documented diagnosis of EAE.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visits 3 and 4
Awards & highlights
Study Summary
This trial is testing if mepolizumab can help people with EAE by making their symptoms less severe and happen less often.
Eligible Conditions
- Angioedema
- Eosinophilia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visits 3 and 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visits 3 and 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in the number and severity of clinical symptoms associated with EAE after 3 doses of mepolizumab (as compared to symptoms logged in the approximately monthly cycle preceding initiation of mepolizumab).
Secondary outcome measures
A =75% reduction in peak blood eosinophil count following the first dose of mepolizumab (as compared to the peak eosinophil count in the cycle preceding initiation of mepolizumab therapy).
Sustained reduction of eosinophilia after administration of mepolizumab (at Visit 8).
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Subjects will receive mepolizumab 700 mg IV x 3 doses at approximately one month intervals, at predicted eosinophil nadir (2-3 weeks after peak), at study visits 4, 6, and 7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nucala (mepolizumab)
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,480,695 Total Patients Enrolled
1 Trials studying Angioedema
16 Patients Enrolled for Angioedema
Paneez Khoury, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
1 Previous Clinical Trials
26 Total Patients Enrolled
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