Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Phase 4

Recruiting

• Conditions: Angioedema
• Interventions: Biological: Lanadelumab 300 mg

• Registration Number: NCT06818474
• Lead Sponsor: Bernstein Clinical Research Center

Brief Summary

use of lanadelumab in patients with acquired angioedema

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-10
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open-label administration	Lanadelumab 300 mg	all subjects receive open-label lanadelumab

Primary Outcome Measures

Name	Time	Method
Primary Objective	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

Trial Locations

Locations (1)

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States