Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

NCT ID: NCT06818474

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2027-12-01

Brief Summary

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use of lanadelumab in patients with acquired angioedema

Detailed Description

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Conditions

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Angioedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all subjects will receive active treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open-label administration

all subjects receive open-label lanadelumab

Group Type OTHER

Lanadelumab 300 mg

Intervention Type BIOLOGICAL

no other intervention

Interventions

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Lanadelumab 300 mg

no other intervention

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bernstein Clinical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Jonathan A. Bernstein, MD

PI/ Owner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

5139314181

Locations

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Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karen Berendts

Role: CONTACT

513-354-1746

Jonathan Bernstein, MD

Role: CONTACT

Facility Contacts

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Karen Berendts

Role: primary

513-354-1746

Other Identifiers

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Tak-02

Identifier Type: -

Identifier Source: org_study_id

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