RECRUITING

A Phase 2 in Adult Subjects With Hereditary Angioedema

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 2 in Adult Subjects with Hereditary Angioedema

Official Title

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

Quick Facts

Study Start:2025-02-28

Study Completion:2028-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06846398

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Ying N/A Zhang, Master

CONTACT

+8618806137286

YingZhang@argobiopharma.com

Principal Investigator

Markus Magerl, Doctor

PRINCIPAL_INVESTIGATOR

Charite-Universitaetsmedizin Berlin - Klinik fuer Dermatologie Venerologie und Allergologie

Study Locations (Sites)

Raffi Tachdjian, MD Inc

Santa Monica, California, 90404

United States

Institute for Asthma and Allergy - Wheaton

Silver Spring, Maryland, 20902

United States

Washington University School of Medicine

St. Louis, Missouri, 63141

United States

Duke University Medicine Center

Durham, North Carolina, 27705

United States

Penn State Milton S. Hershey MC - Penn State

Hershey, Pennsylvania, 17033

United States

Inova Clinical Trials and Research Center

Falls Church, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28

Study Completion Date2028-03-30

Study Record Updates

Study Start Date2025-02-28

Study Completion Date2028-03-30

Terms related to this study

Additional Relevant MeSH Terms

Hereditary Angioedema (HAE)