A Phase 2 in Adult Subjects With Hereditary Angioedema

NCT06846398 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: BW-20805-2001
• Study Type: interventional
• Target: 25
• Locations: 6 countries
• Sites: 18

Brief Summary

A Phase 2 in Adult Subjects with Hereditary Angioedema

Conditions

Hereditary Angioedema (HAE)

Outcome Measures

Primary Outcomes (1)

• To determine the prophylactic effect of in HAE attack rate.

  Change in time-normalized monthly (per 4 weeks) HAE attack rate from baseline to Day169

  from baseline to Day169

Secondary Outcomes (1)

• To evaluate the safety and tolerability of multiple doses of BW-20805.

  up to 96 weeks

Study Arms (3)

Cohort 1

EXPERIMENTAL

BW-20805 600 mg Q24W\*2

Drug: BW-20805

Cohort 2

EXPERIMENTAL

BW-20805 300 mg Q24W\*2

Drug: BW-20805

Cohort 3

EXPERIMENTAL

BW-20805 300 mg Q12W\*2

Drug: BW-20805

Interventions

BW-20805 DRUG

SC administrations of BW-20805 600 mg on Day1 to Day673

Cohort 1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Argo Biopharmaceutical Co., Ltd.: lead

Study Sites (18)

Institute for Asthma and Allergy - Wheaton

Silver Spring, Maryland, 20902, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63141, United States

Location

Duke University Medicine Center

Durham, North Carolina, 27705, United States

Location

Penn State Milton S. Hershey MC - Penn State

Hershey, Pennsylvania, 17033, United States

Location

Inova Clinical Trials and Research Center

Falls Church, Virginia, 22031, United States

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 130030, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichaun, 610041, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Universitätsmedizin der Johannes Gutenberg

Mainz, Rhineland-Palatinate, 55101, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 12200, Germany

Location

Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco

Catania, Catania, 95125, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Florence, 50134, Italy

Location

Azienda Ospedale - Universita di Padova

Padova, PD, 35128, Italy

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, 31-066, Poland

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Markus Magerl, Doctor

  Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 26, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); DE (2); PL (1); US (5); CN (6); ES (1)