A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects With Hereditary Angioedema
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A Phase 2 in Adult Subjects with Hereditary Angioedema
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Maryland
Institute for Asthma and Allergy - Wheaton
RECRUITING
Silver Spring
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke University Medicine Center
RECRUITING
Durham
Pennsylvania
Penn State Milton S. Hershey MC - Penn State
RECRUITING
Hershey
Virginia
Inova Clinical Trials and Research Center
RECRUITING
Falls Church
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
West China Hospital, Sichuan University
RECRUITING
Chengdu
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The First Hospital of Lanzhou University
RECRUITING
Lanzhou
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Yantai Yuhuangding Hospital
RECRUITING
Yantai
Germany
Charité - Universitätsmedizin Berlin
RECRUITING
Berlin
Universitätsmedizin der Johannes Gutenberg
RECRUITING
Mainz
Italy
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco
RECRUITING
Catania
Azienda Ospedaliero-Universitaria Careggi
RECRUITING
Florence
Azienda Ospedale - Universita di Padova
NOT_YET_RECRUITING
Padua
Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
NOT_YET_RECRUITING
Krakow
Spain
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Contact Information
Primary
Ying N/A Zhang, Master
YingZhang@argobiopharma.com
+8618806137286
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 24
Treatments
Experimental: Cohort 1
BW-20805 600 mg Q24W\*2
Experimental: Cohort 2
BW-20805 300 mg Q24W\*2
Experimental: Cohort 3
BW-20805 300 mg Q12W\*2
Related Therapeutic Areas
Sponsors
Leads: Shanghai Argo Biopharmaceutical Co., Ltd.