Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
1 other identifier
interventional
5
1 country
1
Brief Summary
use of lanadelumab in patients with acquired angioedema
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2024
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 5, 2025
CompletedFirst Posted
Study publicly available on registry
February 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
February 25, 2025
February 1, 2025
3.3 years
February 5, 2025
February 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Objective
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
12 months
Study Arms (1)
open-label administration
OTHERall subjects receive open-label lanadelumab
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Bernstein, MD
5139314181
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI/ Owner
Study Record Dates
First Submitted
February 5, 2025
First Posted
February 10, 2025
Study Start
June 1, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
February 25, 2025
Record last verified: 2025-02