Actively Recruiting
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
Led by Bernstein Clinical Research Center · Updated on 2025-02-25
5
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of lanadelumab for long-term prevention of attacks in patients with acquired angioedema (AAE). This phase 4 study focuses on patients who experience recurrent angioedema attacks without urticaria and have specific blood markers such as decreased C1 inhibitor levels and presence of anti-C1INH antibody or paraproteinemia. The goal is to assess lanadelumab's role in reducing attack frequency over time. All participants in the study will receive open-label lanadelumab at a dose of 300 mg. This means everyone enrolled will be treated with lanadelumab without a comparison group or placebo. The treatment is administered to evaluate its effect on attack prevention in this patient population. During the study, participants will be monitored for at least 12 months to observe the primary outcome related to attack frequency and treatment impact. Researchers will collect data on attacks and overall health status to assess the long-term effects of lanadelumab. Participants will have regular study visits and assessments to track their condition and treatment response.
CONDITIONS
Brief Title
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acquired angioedema with recurrent attacks without urticaria
- Decreased C1 inhibitor functional and quantitative levels, decreased C4 and C1q levels
- Presence of anti-C1INH antibody and/or paraproteinemia (e.g., monoclonal gammopathy of unknown significance)
- Historical attack rate of at least one attack per month before starting tranexamic acid
You will not qualify if you...
- History of anaphylaxis or hypersensitivity to biologics
- History of major systemic disease not well controlled as judged by the principal investigator
- Women who are pregnant or breastfeeding
- Concurrent participation in other clinical trials
- Diagnosis of hereditary angioedema Type 1 or 2 with normal complement levels
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive open-label Lanadelumab 300 mg as long-term prophylaxis for acquired angioedema.
Regular visits during treatment period as determined by study protocol
Trial Site Locations
Total: 1 location
1
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States, 45236
Actively Recruiting
Research Team
K
Karen Berendts
J
Jonathan Bernstein, MD
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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