HAELO: A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Status: Active_not_recruiting
Location: See all (30) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:
• Age ≥16 years
• Clinical history consistent with HAE-C1INH-Type 1 or -Type 2
• Ability to provide evidence of HAE attacks (confirmed by the Investigator) to meet the screening requirement
• Must agree to refrain from the use of long-term prophylactic therapies from the start of the screening period through the end of the Primary Observation Period. PI must be in agreement that it is medically acceptable for the participant to do so.
• Must have access to, and the ability to use, on-demand medication(s) to treat potential angioedema attacks
• Adequate chemistry and hematology measures at screening
• Must agree not to participate in another interventional study for the duration of this trial.
• Must be capable of providing signed informed consent. Participants 16 to \< 18 years of age, whose legal guardian provides informed consent, must provide assent.
• Must agree to follow contraception requirements
Locations
United States
Arizona
Medical Research of Arizona
Scottsdale
California
University of California, San Diego (UCSD)
San Diego
Raffi Tachdjian MD, Inc
Santa Monica
Allergy & Asthma Clinical Research
Walnut Creek
Colorado
IMMUNOe International Research Centers
Centennial
Asthma & Allergy Associates
Colorado Springs
Florida
University of South Florida
Tampa
Massachusetts
Massachusetts General Hospital
Boston
Michigan
Henry Ford Health System
Detriot
Missouri
Washington University in St. Louis
St Louis
New York
NYU Langone Health - Long Island
Mineola
Icahn School of Medicine at Mount Sinai
New York
Ohio
Bernstein Clinical Research Center, LLC
Cincinnati
Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey
Texas
AARA Research Center
Dallas
Other Locations
Australia
Campbelltown Hospital
Campbelltown
The Alfred Hospital
Melbourne
Royal Melbourne Hospital
Parkville
Canada
University of Alberta
Edmonton
Ottawa Allergy Research Corporation
Ottawa
France
CHU Grenoble-Alpes - Hopital Michallon
Grenoble
CHU de Lille - Hopital Claude Huriez
Lille
AP-HM - Hopital de la Timone
Marseille
Germany
Charite Universitaetsmedizin Berlin
Berlin
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt
Medizinische Hochschule Hannover (MHH)
Hanover
Netherlands
Amsterdam UMC - Locatie AMC
Amsterdam
New Zealand
New Zealand Clinical Research (NZCR)
Auckland
South Africa
University of Cape Town - Lung Institute - Lung Clinical Research Unit
Cape Town
United Kingdom
Cambridge University Hospitals NHS Foundation Trust