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New injection shows promise for long-term prevention of rare swelling disorder

NCT ID NCT04739059

Disease control Sponsor: CSL Behring 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the long-term safety and effectiveness of garadacimab, a monthly injection, for preventing attacks of hereditary angioedema (HAE) — a rare condition causing severe swelling. 171 people aged 12 and older who had frequent HAE attacks took part. The goal was to see if the drug could safely reduce attack rates over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
garadacimab (a monoclonal antibody injection)
What this could lead to
If successful, this could provide a long-term preventive option to reduce swelling attacks in people with hereditary angioedema.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. Side effects or lack of lasting benefit are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

171 people

The number who actually took part.

Started

Mar 2021

Finished

Nov 2025

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

12 years and older

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: * Males and females aged ≥ 12 years * Diagnosed with clinically confirmed C1-INH HAE * Experienced ≥ 3 HAE attacks during the 3 months before Screening * Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only) * Experienced at least an average of 1 HAE attack per month during the Run-in Period Exclusion Criteria: * Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria * Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period * Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period. * Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening * Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312 * Pregnant, breastfeeding, or not willing to cease breastfeeding

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Conditions

The condition(s) this trial relates to.

hereditary angioedema hereditary angioedema with C1Inh deficiency

As listed by the trial registrant

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

Hereditary angioedema

Contacts and locations

Locations

  • AARA Research Center

    Dallas, Texas, 75231, United States

  • Allergy & Asthma Clinical Research

    Walnut Creek, California, 94598, United States

  • Amsterdam UMC, location AMC

    Amsterdam, 1105, Netherlands

  • Auckland City Hospital

    Grafton, Auckland, 1023, New Zealand

  • Barzilai University Medical Center

    Ashkelon, 7830604, Israel

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Campbelltown Hospital / Western Sydney University

    Campbelltown, New South Wales, 2560, Australia

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Clinical Research Center of Alabama

    Birmingham, Alabama, 35209, United States

  • Clover Hospital

    Kanagawa, Kugenumaishigami, Fujisawa-shi, 251-0025, Japan

  • Donald S. Levy M.D.

    Orange, California, 92868, United States

  • Fiona Stanley Hospital, Department of Clinical Immunology

    Murdoch, Western Australia, 6150, Australia

  • Gordon Sussman Clinical Research

    Toronto, Ontario, M3B 3S6, Canada

  • HZRM Haemophilie Zentrum Rhein Main GmbH

    Mörfelden-Walldorf, 64546, Germany

  • Hospital Gregorio Marañón, Servicio de Alergia

    Madrid, 28007, Spain

  • Hospital Universitari General de La Vall d'Hebron

    Barcelona, 8035, Spain

  • Institute for Asthma and Allergy PC

    Chevy Chase, Maryland, 20815, United States

  • Johannes Gutenberg-Universität KöR, Hautklinik und Poliklinik der Universitätsmedizin, Clinical Research Center

    Mainz, 55131, Germany

  • Juntendo University Hospital

    Tokyo, Hongo Bunkyo-ku, 113-8431, Japan

  • Koga Community Hospital

    Shizuoka, Daikakuji Yaizu-shi, 425-0088, Japan

  • Little Rock Allergy & Asthma Clinic

    Little Rock, Arkansas, 72205, United States

  • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital

    Miyakojima-ku, Osaka-shi, 534-0021, Japan

  • McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251, United States

  • Mie University Hospital

    Mie, Edobashi, Tsu-shi, Edobashi, Tsu-shi, Japan

  • Montreal Clinical Research Institute

    Montreal, Quebec, H2W 1R7, Canada

  • NRC Institute of Immunology FMBA Russia

    Moscow, 115522, Russia

  • National Hospital Organization Disaster Medical Center

    Tokyo, Midoricho, Tachikawa-shi, 190-0014, Japan

  • Ottawa Allergy Research Corp

    Ottawa, Ontario, K1H 1E4, Canada

  • PennState Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Raffi Tachdjian MD, Inc.

    Santa Monica, California, 90404, United States

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340, United States

  • Saga University Hospital

    Saga, Nebeshima, Saga-shi, 849-8501, Japan

  • Saitama Medical Center

    Saitama, Kamoda Kawagoe-shi, 350-8550, Japan

  • Saiyu Soka Hospital

    Saitama, Matsubara Soka-shi, 340-0041, Japan

  • Semmelweis Egyetem Altalanos Orvostudományi Kar Belgyógyászati és Hematológiai Klinika

    Budapest, 1088, Hungary

  • St. Marianna University School of Medicine Hospital

    Kanagawa, Kawasaki-shi, 216-8511, Japan

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The University of Hong Kong, Queen Mary Hospital

    Hong Kong, Hong Kong

  • University Hospital Motol

    Prague, 150 06, Czechia

  • University hospital St. Anna Ustav klinicke imunologie a alergologie, Fakultní nemocnice u sv. Anny v Brně

    Brno, 65691, Czechia

  • University of Alberta - Research Transition Facility

    Edmonton, Alberta, T6G 2B7, Canada

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

More trials for these conditions

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