A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
EMPOWER
An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)
2 other identifiers
observational
168
3 countries
29
Brief Summary
The main aim of this study is to compare the HAE attack rate before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II. Data from participants will be collected for at least 24 months. Participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2019
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2019
CompletedFirst Posted
Study publicly available on registry
February 19, 2019
CompletedStudy Start
First participant enrolled
March 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2022
CompletedMarch 30, 2023
March 1, 2023
3.6 years
February 18, 2019
March 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Hereditary Angioedema (HAE) Attacks
Number of HAE attacks before and after lanadelumab initiation will be reported.
From enrollment up to 36 months
Secondary Outcomes (14)
Dose of Lanadelumab Injections
From enrollment up to 36 months
Frequency of Lanadelumab Injections
From enrollment up to 36 months
Proportion of Injections Based on the Type of Administration of Lanadelumab
From enrollment up to 36 months
Time From Diagnosis to Lanadelumab Initiation
From enrollment up to 36 months
Proportion of Participants who Discontinue Lanadelumab
From enrollment up to 36 months
- +9 more secondary outcomes
Study Arms (1)
Type I or Type II HAE Participants
Participants with Type I or Type II HAE will be followed for 24 or 36 months depending upon enrollment date. Data collection will cease at the end of follow-up period, at the time of withdrawal, lost to follow-up, or death whichever comes first.
Eligibility Criteria
Participants with a diagnosis of Type I or Type II HAE.
You may qualify if:
- Voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study. Expression of understanding and agreement by fully informed parent(s) or legal guardian is required to permit the investigator to enroll a child in this study. The choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations.
- Diagnosis of HAE Type I or Type II.
- Ability to use a mobile device for data collection in the study.
You may not qualify if:
- Participation in any interventional clinical trial at the time of enrollment.
- Unable to provide written, signed, and dated informed consent/assent.
- Investigator believes that the participant is not a suitable candidate for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (29)
Clinical Research Center of Alabama
Birmingham, Alabama, 35209, United States
Medical Research of Arizona
Scottsdale, Arizona, 85248, United States
University of California San Diego
San Diego, California, 92122, United States
AIRE Medical of Los Angeles
Santa Monica, California, 90404, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
University of South Florida Asthma, Allergy & Immunology
Tampa, Florida, 33613, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160, United States
Institute for Asthma & Allergy - Chevy Chase
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2752, United States
University of Michigan
Ann Arbor, Michigan, 48106, United States
Mid West Immunology Clinic
Plymouth, Minnesota, 55446, United States
Washington University
St Louis, Missouri, 63141, United States
Riverside Medical Group, Belleville
Belleville, New Jersey, 07109, United States
Jay M Kashkin, MD Allergy, Asthma and Immunology
Fair Lawn, New Jersey, 07410, United States
Mount Sinai
New York, New York, 10029, United States
Clinical Research of Charlotte
Charlotte, North Carolina, 28277, United States
Duke Asthma, Allergy & Airway Center
Durham, North Carolina, 27704, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231, United States
Portland Clinical Research/AAIM Care
Happy Valley, Oregon, 97086, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
AARA Research Center
Dallas, Texas, 75231, United States
Seattle Allergy & Asthma Research Institute
Seattle, Washington, 98115, United States
University of Calgary - Heritage Medical Research Clinic
Calgary, Alberta, T2N 2T9, Canada
McMaster University Health Sciences Center
Hamilton, Ontario, L8S 4K1, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
CHUM Hôtel-Dieu
Montreal, Quebec, H2X 0A9, Canada
Clinique Specialisée en Allergie de la Capitale
Québec, G1V 4W2, Canada
Rafael H Zaragoza-Urdaz
San Juan, 00918, Puerto Rico
Related Publications (4)
Betschel SD, Chapdelaine H, Gagnon R, Goodyear MD, Keith PK, El-Zoeiby A, Khutoryansky N, Castaner DN. Long-term effectiveness and safety of lanadelumab in Canadian patients with hereditary angioedema: a subanalysis of the EMPOWER study. Allergy Asthma Clin Immunol. 2026 Jan 21. doi: 10.1186/s13223-025-01007-9. Online ahead of print.
PMID: 41566486DERIVEDZanichelli A, Wuillemin WA, Aygoren-Pursun E, Banerji A, Busse PJ, Betschel SD, Cancian M, Gagnon R, Goodyear MD, Kinaciyan T, Kessel A, Magerl M, Recke A, Wedner HJ, Estepan DN, Watt M, Andresen I, Juethner S, Khutoryansky N, Martinez-Saguer I. Lanadelumab's impact on hereditary angioedema control and quality of life across disease activity subgroups: Real-world evidence. Ann Allergy Asthma Immunol. 2025 Nov;135(5):560-569.e2. doi: 10.1016/j.anai.2025.07.025. Epub 2025 Sep 6.
PMID: 40769455DERIVEDBernstein JA, Betschel SD, Busse PJ, Banerji A, Wedner HJ, Manning M, Zaragoza-Urdaz RH, Anderson J, Gagnon R, Baptist AP, Soteres D, Lumry WR, Craig T, Petroni D, Hsu FI, Nova Estepan D, Juethner S, Watt M, Khutoryansky N, Zuraw BL; EMPOWER Investigators. Sustained Effectiveness, Tolerability, and Safety of Long-Term Prophylaxis with Lanadelumab in Hereditary Angioedema: The Prospective, Phase 4, Noninterventional EMPOWER Real-World Study. Adv Ther. 2025 Aug;42(8):3882-3901. doi: 10.1007/s12325-025-03226-3. Epub 2025 Jun 12.
PMID: 40504359DERIVEDTachdjian R, Banerji A, Busse PJ, Agmon-Levin N, Anderson J, Cancian M, Spadaro G, Enciu C, Estepan DN, Khutoryansky N, Jain S, Recke A. Effective long-term prophylaxis with lanadelumab in adolescents with hereditary angioedema: EMPOWER/ENABLE. Pediatr Allergy Immunol. 2025 Apr;36(4):e70072. doi: 10.1111/pai.70072.
PMID: 40171989DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Shire
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2019
First Posted
February 19, 2019
Study Start
March 30, 2019
Primary Completion
October 22, 2022
Study Completion
October 22, 2022
Last Updated
March 30, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.