Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06818474

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

use of lanadelumab in patients with acquired angioedema

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Angioedema Cardiovascular Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236, United States

Location status: Recruiting

Location contact

Jonathan Bernstein, MD

PRINCIPAL_INVESTIGATOR

Karen Berendts

CONTACT

[email protected]

513-354-1746

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanadelumab 300 mg

Biological

no other intervention

Primary outcomes

  1. Primary Objective

    Time frame: 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Bernstein, MD

CONTACT

[email protected]

Karen Berendts

CONTACT

[email protected]

513-354-1746

Sponsors and collaborators

Lead sponsor

Bernstein Clinical Research Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.