A Phase 2 in Adult Subjects With Hereditary Angioedema

Last updated: August 3, 2025
Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Allergy

Urticaria

Allergies & Asthma

Treatment

BW-20805

Clinical Study ID

NCT06846398
BW-20805-2001
  • Ages 18-70
  • All Genders

Study Summary

A Phase 2 in Adult Subjects with Hereditary Angioedema

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

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: BW-20805
Phase: 2
Study Start date:
February 28, 2025
Estimated Completion Date:
March 30, 2028

Study Description

A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of BW-20805 in Adult Subjects with Hereditary Angioedema

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichaun 610041
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • University Hospital Frankfurt

    Frankfurt, HE 60590
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover (MHH)

    Hannover, Lower Saxony 30625
    Germany

    Active - Recruiting

  • Universitätsmedizin der Johannes Gutenberg

    Mainz, Rhineland-Palatinate 55101
    Germany

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200
    Germany

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Firenze, Florence 50134
    Italy

    Active - Recruiting

  • Azienda Ospedale - Universita di Padova

    Padova, PD 35128
    Italy

    Site Not Available

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

    Catania, 95125
    Italy

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Raffi Tachdjian, MD Inc

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Institute for Asthma and Allergy - Wheaton

    Silver Spring, Maryland 20902
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Duke University Medicine Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Penn State Milton S. Hershey MC - Penn State

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Inova Clinical Trials and Research Center

    Falls Church, Virginia 22031
    United States

    Active - Recruiting

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