A Phase 2 in Adult Subjects With Hereditary Angioedema

Running, not enrolling · Phase 2

Conditions studied: Hereditary Angioedema (HAE)

In brief

A Phase 2 in Adult Subjects with Hereditary Angioedema

Key facts

Study ID: NCT06846398
Run by: Shanghai Argo Biopharmaceutical Co., Ltd.
People needed: 25
Starts: 2025-02-28
Expected to finish: 2028-03-30
Last updated by the study team: 2026-04-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Institute for Asthma and Allergy - Wheaton — Silver Spring, Maryland, United States
Washington University School of Medicine — St Louis, Missouri, United States
Duke University Medicine Center — Durham, North Carolina, United States
Penn State Milton S. Hershey MC - Penn State — Hershey, Pennsylvania, United States
Inova Clinical Trials and Research Center — Falls Church, Virginia, United States
Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University — Lanzhou, Gansu, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China
Yantai Yuhuangding Hospital — Yantai, Shandong, China
West China Hospital, Sichuan University — Chengdu, Sichaun, China
First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China
Universitätsmedizin der Johannes Gutenberg — Mainz, Rhineland-Palatinate, Germany
Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany
Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco — Catania, Catania, Italy
Azienda Ospedaliero-Universitaria Careggi — Florence, Florence, Italy
Azienda Ospedale - Universita di Padova — Padova, PD, Italy
SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow, Lesser Poland Voivodeship, Poland
Hospital Universitario Virgen del Rocío — Seville, Sevilla, Spain

Full record on ClinicalTrials.gov

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