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New shot could stop painful swelling attacks in kids

NCT ID NCT05819775

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called Garadacimab in 22 children aged 2 to 11 with hereditary angioedema, a condition that causes sudden, painful swelling. The drug is given as a shot under the skin to prevent attacks. The study looked at safety and how well it works. It has already been completed.

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 lab-made antibody given as a shot under the skin)
What this could lead to
If it works, this could give children with hereditary angioedema a new option to prevent painful swelling attacks.
What could go wrong
This is a small, completed study with only 22 children, so results may not apply to everyone. Side effects or lack of effectiveness 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

22 people

The number who actually took part.

Started

May 2023

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

2 to 11 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: 1. Male or female 2. Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age 3. Diagnosed with clinically confirmed C1-INH HAE 4. Experienced ≥ 2 HAE attacks during the 6 months before Screening Exclusion Criteria: 1. Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type 3 2. Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks within a minimum of 2 weeks before the Treatment Period 3. Participation in another interventional clinical study during the 30 days before the Treatment Period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer 4. Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening 5. Currently receiving a therapy not permitted during the study 6. Being pregnant or 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 (HAE)

Contacts and locations

Locations

  • AARA Research Center

    Dallas, Texas, 75231, United States

  • Barzilai University Medical Center

    Ashkelon, 7830604, Israel

  • Bernstein Clinical Research

    Cincinnati, Ohio, 45236, United States

  • Campbelltown Hospital, Western Sydney University

    Campbelltown, NSW 2560, Australia

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Donald S. Levy M.D.

    Orange, California, 92868, United States

  • HZRM Hämophilie Zentrum Rhein Main GmbH

    Frankfurt am Main, Hesse, 60596, Germany

  • Medical Research of Arizona

    Scottsdale, Arizona, 85251, United States

  • Ottawa Allergy Research Corp

    Ottawa, K1H1E4, 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

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590, Germany

More trials for these conditions

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