Using lanadelumab to prevent acquired angioedema attacks
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
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 |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bernstein Clinical Research Center Academic / other |
| Drugs / interventions | lanadelumab |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06818474 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with acquired angioedema who experience recurrent attacks and meet specific laboratory criteria.
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.
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 performed: While this approach is focused on acquired angioedema, similar studies using monoclonal antibodies for other types of angioedema have shown promising results.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.