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New hope for HAE patients: experimental drug aims to slash attack rate

NCT ID NCT06846398

Disease control Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called BW-20805 in 25 adults with hereditary angioedema (HAE), a condition that causes sudden, painful swelling. The goal is to see if the drug can reduce how often attacks happen over about 6 months. Participants must have had at least 2 attacks in the 8 weeks before starting the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema type 1 hereditary angioedema type 2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hereditary angioedema (HAE)

Contacts and locations

Locations

  • Azienda Ospedale - Universita di Padova

    Padova, PD, 35128, Italy

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

    Catania, Catania, 95125, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Florence, 50134, Italy

  • Charité - Universitätsmedizin Berlin

    Berlin, State of Berlin, 12200, Germany

  • Duke University Medicine Center

    Durham, North Carolina, 27705, United States

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032, China

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla, 41013, Spain

  • Inova Clinical Trials and Research Center

    Falls Church, Virginia, 22031, United States

  • Institute for Asthma and Allergy - Wheaton

    Silver Spring, Maryland, 20902, United States

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Penn State Milton S. Hershey MC - Penn State

    Hershey, Pennsylvania, 17033, United States

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship, 31-066, Poland

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000, China

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

    Wuhan, Hubei, 130030, China

  • Universitätsmedizin der Johannes Gutenberg

    Mainz, Rhineland-Palatinate, 55101, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63141, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichaun, 610041, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.