Evaluating the effects of lanadelumab on bradykinin angioedema
Evaluation of the Efficacy of Kallikrein Inhibition by Lanadelumab for Patients With Bradykinin Angioedema: a Cohort Study
This study is testing if a new medication called lanadelumab can help people with bradykinin angioedema by reducing their swelling episodes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Drugs / interventions | lanadelumab |
| Locations | 2 sites (Grenoble and 1 other locations) |
| Trial ID | NCT04597944 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to assess the efficacy of lanadelumab, a monoclonal antibody that inhibits plasma kallikrein, in patients suffering from bradykinin angioedema. The study focuses on measuring levels of cleaved high molecular-weight kininogen and the immunogenicity of lanadelumab. By targeting the kallikrein-kinin cascade, the study seeks to provide insights into a potential prophylactic treatment for this debilitating condition characterized by unpredictable swelling episodes. Participants will be monitored for their response to treatment and any associated biological changes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with hereditary or acquired angioedema who are currently being treated with lanadelumab.
Not a fit: Patients who are pregnant, nursing, or unable to provide biological samples will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and prevention of life-threatening episodes in patients with bradykinin angioedema.
How similar studies have performed: While the approach of using kallikrein inhibitors is promising, this specific observational study is novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Grenoble and 1 other locations
- Chu Grenoble Alpes — Grenoble, France (Recruiting)
- CHU Rouen — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Federica DEFENDI — Grenoble Alpes University Hospital
- Study coordinator: Federica Defendi, PhD
- Email: fdefendi@chu-grenoble.fr
- Phone: +330476765416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.