Angioedema
Conditions
Brief summary
use of lanadelumab in patients with acquired angioedema
Interventions
BIOLOGICALLanadelumab 300 mg
no other intervention
Sponsors
Bernstein Clinical Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
all subjects will receive active treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance) * historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA)
Exclusion criteria
* History of anaphylaxis or hypersensitivity to biologics * History of major systemic disease not well controlled in opinion of the PI * Women who are pregnant or breast feeding * Concurrent participation in other clinical trials * HAE Type 1 or 2 and normal complement HAE
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Objective | 12 months | Rate of investigator confirmed AAE attacks during study period, as measured by the ACT. AAE attack will be defined as a unique event during which the study subject will progress from no angioedema to symptoms of angioedema and no further angioedema for 24 hours after resolution of the event with rescu therapy |
Countries
United States
Contacts
Primary ContactKaren Berendts
Backup ContactJonathan Bernstein, MD
Outcome results
None listed