NCT06818474PHASE4Recruiting
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
Bernstein Clinical Research Center
Start Date
6/1/2024
Completion Date
12/1/2027
Summary
use of lanadelumab in patients with acquired angioedema
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
BIOLOGICAL
Lanadelumab 300 mg
Conditions
Angioedema
Locations
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio 45236
United States