Using lanadelumab to prevent acquired angioedema attacks
Official title: Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
Run by Bernstein Clinical Research Center · NCT06818474 · Data updated 2026-11-12
This study is testing if a new medication called lanadelumab can help people with acquired angioedema have fewer attacks.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Bernstein Clinical Research Center Academic / other |
| Drugs / interventions | lanadelumab |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | September 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT06818474 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with acquired angioedema who experience recurrent attacks and meet specific laboratory criteria.
✕Probably not a fit
Patients with hereditary angioedema types 1 or 2 or those with well-controlled major systemic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of lanadelumab, a monoclonal antibody, for the long-term prevention of recurrent attacks in patients diagnosed with acquired angioedema (AAE). Participants will receive a dose of 300 mg of lanadelumab to assess its efficacy in reducing the frequency of angioedema episodes. The study focuses on patients with specific diagnostic criteria, including decreased C1INH levels and the presence of anti-C1INH antibodies. The goal is to provide a new therapeutic option for managing this condition.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of angioedema attacks for patients suffering from AAE.
How similar studies have gone: While this approach is focused on acquired angioedema, similar studies using monoclonal antibodies for other types of angioedema have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Jonathan Bernstein, MD — 5139314181
- Study coordinator: Karen Berendts
- Email: kberendts@bernsteincrc.com
- Phone: 513-354-1746
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Oral deucrictibant to prevent and treat hereditary angioedema attacks
This trial tests whether daily oral deucrictibant XR can prevent angioedema attacks and whether deucrictibant capsules can quickly relieve acute attacks in adults with bradykinin-mediated hereditary angioedema.
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Angioedema biomarker tests to help diagnose recurrent swelling
This study tests multiple blood-based diagnostic tests to see if they can better identify the cause of recurrent angioedema in patients compared with current tests.
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Creating a database for patients with immune-mediated inflammatory diseases
This study is creating a database and biobank for patients with immune-related diseases to see if new information can help improve treatments and understand their conditions better.
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Registry for patients with angioedema
This study is gathering information from patients with recurring angioedema to better understand the condition and improve treatment options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.