Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Last updated: February 24, 2025
Sponsor: Bernstein Clinical Research Center
Overall Status: Active - Recruiting

Phase

4

Condition

Hives (Urticaria)

Allergy

Allergies & Asthma

Treatment

Lanadelumab 300 mg

Clinical Study ID

NCT06818474
Tak-02
  • Ages > 18
  • All Genders

Study Summary

use of lanadelumab in patients with acquired angioedema

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INHfunctional, quantitative levels, decreased C4 and decreased C1q levels, no familyhistory 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

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

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Lanadelumab 300 mg
Phase: 4
Study Start date:
June 01, 2024
Estimated Completion Date:
December 01, 2027

Connect with a study center

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

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