Recruiting

Lanadelumab

Sponsor:

Bernstein Clinical Research Center

Code:

NCT06818474

Conditions

Angioedema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lanadelumab 300 mg

Study Details

Brief summary:

use of lanadelumab in patients with acquired angioedema

Conditions

Angioedema

Study ID

NCT06818474

Start date

Jun 1, 2024

Status verified date

Feb, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: open-label administration

all subjects receive open-label lanadelumab

Interventions

Lanadelumab 300 mg

no other intervention

Primary outcome measure

  • Primary Objective [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Karen Berendts

513-354-1746kberendts@bernsteincrc.com

Jonathan Bernstein, MD

bernstja@ucmail.uc.edu

Locations

Bernstein Clinical Research Center, LLC

Recruiting

Cincinnati, Ohio, United States, 45236

Contacts

Karen Berendts

513-354-1746kberendts@bernsteincrc.com

Principal Investigator:

Jonathan Bernstein, MD

More Information

Sponsor

Bernstein Clinical Research Center

Last update posted

Feb 25, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bernstein Clinical Research Center on 2025-02-25.