Phase
Condition
Allergy
Urticaria
Allergies & Asthma
Treatment
BW-20805
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have given written informed consent and be able to comply with all studyrequirements.
Males or females 18 to 70 years of age at the time of informed consent.
Documented diagnosis of HAE-1/HAE-2.
At least 2 HAE attacks within the 8-week run-in period, as confirmed by aninvestigator based on the protocol-specified definition
Access to and ability to use ≥ 1 acute medication(s)
Female subjects must be non-pregnant;non-lactating, and either surgically sterile
Male subjects with WOCBP partners, dual contraception is required if no surgicallysterile
Exclusion
Exclusion Criteria:
Any clinically significant medical or psychiatric condition or medical history that,in the opinion of the Investigator, makes the subject unsuitable for participationin the study
Any concomitant diagnosis of another form of chronic angioedema, such as acquiredangioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedemaassociated with urticaria
History or presence of carcinoma within 5 years prior to screening, except for basalor squamous cell carcinoma of the skin or carcinoma in situ of the cervix that hasbeen successfully treated.
Have undergone major surgery within 3 months prior to screening.
History of clinically significant arterial or venous thrombosis, or currentclinically significant prothrombotic or bleeding risk
History of allergic reaction to an oligonucleotide or N-acetylgalactosamine
Prior treatment with any oligonucleotides within 6 months if single dose or 12months if multiple doses prior to screening.
Exposure to another investigational drug or biological agent within 30 days orwithin at least 5 half-lives prior to screening.
With ANY of the abnormalities in clinical laboratory tests at screening and run-inperiod
Clinically significant findings on 12-lead electrocardiogram that would place thepatient at risk or interfere with participation in the study at screening.
Positive for Human immunodeficiency virus (HIV), HBsAg, Hepatitis C or syphilisinfection
Active infection requiring systemic antiviral or antimicrobial therapy that will notbe completed prior to dosing.
Study Design
Study Description
Connect with a study center
Peking Union Medical College Hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu 730000
ChinaActive - Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong 264000
ChinaActive - Recruiting
West China Hospital, Sichuan University
Chengdu, Sichaun 610041
ChinaActive - Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
ChinaActive - Recruiting
University Hospital Frankfurt
Frankfurt, HE 60590
GermanyActive - Recruiting
Medizinische Hochschule Hannover (MHH)
Hannover, Lower Saxony 30625
GermanyActive - Recruiting
Universitätsmedizin der Johannes Gutenberg
Mainz, Rhineland-Palatinate 55101
GermanyActive - Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12200
GermanyActive - Recruiting
Azienda Ospedaliero-Universitaria Careggi
Firenze, Florence 50134
ItalyActive - Recruiting
Azienda Ospedale - Universita di Padova
Padova, PD 35128
ItalySite Not Available
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
Catania, 95125
ItalyActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Raffi Tachdjian, MD Inc
Santa Monica, California 90404
United StatesActive - Recruiting
Institute for Asthma and Allergy - Wheaton
Silver Spring, Maryland 20902
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Washington University School of Medicine
St. Louis, Missouri 63141
United StatesSite Not Available
Duke University Medicine Center
Durham, North Carolina 27705
United StatesActive - Recruiting
Penn State Milton S. Hershey MC - Penn State
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Inova Clinical Trials and Research Center
Falls Church, Virginia 22031
United StatesActive - Recruiting
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