Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

use of lanadelumab in patients with acquired angioedema

Study Overview

• Status: Recruiting
• Conditions: Angioedema
• Intervention / Treatment: Biological: Lanadelumab 300 mg

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karen Berendts; Phone Number: 513-354-1746; Email: kberendts@bernsteincrc.com
• Study Contact Backup: Name: Jonathan Bernstein, MD; Email: bernstja@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Recruiting
      • Bernstein Clinical Research Center, LLC
      • Contact: Karen Berendts; Phone Number: 513-354-1746; Email: kberendts@bernsteincrc.com
      • Contact: Jonathan Bernstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: open-label administration; all subjects receive open-label lanadelumab	Biological: Lanadelumab 300 mg; no other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	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	12 months

Collaborators and Investigators

• Sponsor: Bernstein Clinical Research Center
• Investigators: Principal Investigator: Jonathan Bernstein, MD, 5139314181

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Angioedema
• Other Study ID Numbers: Tak-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No