BW-20805: SC administrations of BW-20805 600 mg on Day1 to Day673
BW-20805: SC administrations of BW-20805 300 mg every 24 weeks on Day1 to Day169;Day337 to Day673
BW-20805: SC administrations of BW-20805 300 mg every 12 weeks on Day 1 to Day 589
Study summary
A Phase 2 in Adult Subjects with Hereditary Angioedema
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Must have given written informed consent and be able to comply with all study requirements.
* 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 an investigator 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 surgically sterile
Exclusion Criteria:
* Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
* Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
* History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
* Have undergone major surgery within 3 months prior to screening.
* History of clinically significant arterial or venous thrombosis, or current clinically 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 12 months if multiple doses prior to screening.
* Exposure to another investigational drug or biological agent within 30 days or within at least 5 half-lives prior to screening.
* With ANY of the abnormalities in clinical laboratory tests at screening and run-in period
* Clinically significant findings on 12-lead electrocardiogram that would place the patient at risk or interfere with participation in the study at screening.
* Positive for Human immunodeficiency virus (HIV), HBsAg, Hepatitis C or syphilis infection
* Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to dosing.
Primary outcome measure(s)
To determine the prophylactic effect of in HAE attack rate. — from baseline to Day169 Change in time-normalized monthly (per 4 weeks) HAE attack rate from baseline to Day169
Trial sites (18)
Facility
City
Region
Status
Institute for Asthma and Allergy - Wheaton
Silver Spring
Maryland
Washington University School of Medicine
St Louis
Missouri
Duke University Medicine Center
Durham
North Carolina
Penn State Milton S. Hershey MC - Penn State
Hershey
Pennsylvania
Inova Clinical Trials and Research Center
Falls Church
Virginia
Peking Union Medical College Hospital
Beijing
Beijing Municipality
The First Hospital of Lanzhou University
Lanzhou
Gansu
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Hubei
Yantai Yuhuangding Hospital
Yantai
Shandong
West China Hospital, Sichuan University
Chengdu
Sichaun
First Affiliated Hospital of Kunming Medical University
Kunming
Yunnan
Universitätsmedizin der Johannes Gutenberg
Mainz
Rhineland-Palatinate
Charité - Universitätsmedizin Berlin
Berlin
State of Berlin
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
Catania
Catania
Azienda Ospedaliero-Universitaria Careggi
Florence
Florence
Azienda Ospedale - Universita di Padova
Padova
PD
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow
Lesser Poland Voivodeship
Hospital Universitario Virgen del Rocío
Seville
Sevilla
More Shanghai Argo Biopharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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