Lanadelumab in Bradykinin Angioedema (KALAN)

March 18, 2024 updated by: University Hospital, Grenoble

Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study

A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema

Study Overview

Status

Recruiting

Conditions

Detailed Description

The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.

The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).

Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.

The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hereditary or Acquired Angiodema

Description

Inclusion Criteria:

  • Male/female >18 years old
  • Patient with hereditary or acquired angioedema
  • Patient treated by lanadelumab
  • Patient whose the biological explorations have been carried out or will be carried out at Laboratory of Immunology of CHUGA
  • Informed consent is obtained from the participant

Exclusion Criteria:

  • Absence of biological material at T0 and M3 (stored for routine analysis)
  • Person under guardianship or curatorship
  • Female who is pregnant, nursing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants with Hereditary or Acquired Angioedema
Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
Time Frame: 3 months
Levels of cleaved HK measured by Western Blot
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits
Time Frame: Day 7; 6, 12 and if possible 24 months

Levels of cleaved HK as measured by Western Blot Ratio Day 7/ Day 0, Ratio Month 6/ Day 0, Ratio Month 12/ Day (and if possible Month 24/ Day 0) of the levels of cleaved HK as measured by Western Blot

- SE2: antidrug antibodies in the sera of patients at Months 3, 6, 12 (and if possible Month 24).
Day 7; 6, 12 and if possible 24 months
Immunogenicity of lanadelumab
Time Frame: Months 3, 6, 12 (and 24 if possible)
Levels of antidrug antibodies in the sera of patients
Months 3, 6, 12 (and 24 if possible)
Evaluation of therapeutic escape
Time Frame: Months 3, 6, 12 and if possible 24
Increase/absence of decrease of the number of attacks during lanadelumab administration
Months 3, 6, 12 and if possible 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Federica DEFENDI, Grenoble Alpes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2020

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC20.187
  • 2020-A01528-31 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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