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Search / Trial NCT06818474

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Launched by BERNSTEIN CLINICAL RESEARCH CENTER · Feb 5, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called lanadelumab to see how well it works for preventing attacks in patients with a condition known as acquired angioedema (AAE). AAE is a type of swelling that can happen suddenly and without an obvious cause. The trial is currently recruiting participants aged 65 to 74, and it is open to both men and women. To be eligible, participants need to have a specific diagnosis of AAE and have experienced at least one attack per month before starting a different treatment called tranexamic acid.

If you decide to take part in this trial, you can expect to receive lanadelumab as part of the study. You'll be closely monitored by the research team to track how the medication affects your condition. It's important to know that if you have had severe allergic reactions to similar medications, are currently pregnant or breastfeeding, or have certain other health issues, you may not be able to join this study. This trial aims to improve the understanding of long-term treatment options for patients with AAE, which could lead to better management of this condition in the future.

Gender

ALL

Eligibility 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

About Bernstein Clinical Research Center

Bernstein Clinical Research Center is a leading organization dedicated to advancing medical science through innovative clinical trials. With a commitment to improving patient outcomes, the center specializes in conducting Phase I-IV clinical studies across various therapeutic areas, including cardiology, endocrinology, and dermatology. Leveraging state-of-the-art facilities and a team of experienced professionals, Bernstein Clinical Research Center ensures rigorous compliance with regulatory standards while prioritizing patient safety and well-being. Their collaborative approach with pharmaceutical companies and healthcare providers fosters the development of groundbreaking therapies, ultimately contributing to the enhancement of public health.

Locations

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Jonathan Bernstein, MD

Principal Investigator

5139314181

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported