Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Bernstein Clinical Research Center

Status and phase: Enrolling; Phase 4

Conditions: Angioedema

Treatments: Biological: Lanadelumab 300 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06818474

Tak-02

Details and patient eligibility

About

use of lanadelumab in patients with acquired angioedema

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

open-label administration

Other group

Description:

all subjects receive open-label lanadelumab

Treatment:

Biological: Lanadelumab 300 mg