RECRUITING

A Phase 2 in Adult Subjects With Hereditary Angioedema

Description

A Phase 2 in Adult Subjects with Hereditary Angioedema

Study Overview

Study Details

Study overview

A Phase 2 in Adult Subjects with Hereditary Angioedema

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

A Phase 2 in Adult Subjects With Hereditary Angioedema

Condition
Hereditary Angioedema (HAE)
Intervention / Treatment

-

Contacts and Locations

Santa Monica

Raffi Tachdjian, MD Inc, Santa Monica, California, United States, 90404

Silver Spring

Institute for Asthma and Allergy - Wheaton, Silver Spring, Maryland, United States, 20902

St. Louis

Washington University School of Medicine, St. Louis, Missouri, United States, 63141

Durham

Duke University Medicine Center, Durham, North Carolina, United States, 27705

Hershey

Penn State Milton S. Hershey MC - Penn State, Hershey, Pennsylvania, United States, 17033

Falls Church

Inova Clinical Trials and Research Center, Falls Church, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shanghai Argo Biopharmaceutical Co., Ltd.,

Markus Magerl, Doctor, PRINCIPAL_INVESTIGATOR, Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie

Study Record Dates

2028-03-30