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New monthly HAE shot tested for safety after switching from current meds

NCT ID NCT06806657

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 2 times

Summary

This study looks at whether it is safe for people aged 12 and older with hereditary angioedema (HAE) to switch from their current preventive medicine to a new monthly injection called garadacimab. Researchers will monitor for side effects over about 3 months. The goal is to see if the switch is well-tolerated.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

18 people

The number who actually took part.

Started

Apr 2025

Finished

Jun 2026

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: * Aged \>= 12 years at the time of providing written informed consent / assent. * Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks. * Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2: * Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria), * C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or * C4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record. * For HAE-nC1INH: Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria); an HAE-associated FXII gene mutation (eg, FXII point mutation Thr328Lys or Thr328Arg, or deletion of 72 base pairs \[c.971\_1018 + 24del72\], or duplication of 18 base pairs \[c.892-909dup\]), as documented in the participant's medical record, OR an HAE-associated plasminogen gene mutation (PLG) gene mutation (eg, PLG point mutation Lys330Glu), as documented in the participant's medical record; C1INH antigen concentration or functional activity 70 to 120% of the normal level, as documented in the participant's medical record. * Use of lanadelumab, berotralstat, or pdC1INH for the prophylactic treatment of HAE and be on a stable (consistent) dose / regimen of such medication for at least 3 months prior to Screening. Exclusion Criteria: * Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria. * Use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against HAE attacks. * Known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.

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Conditions

The condition(s) this trial relates to.

hereditary angioedema

As listed by the trial registrant

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

Hereditary angioedema

Contacts and locations

Locations

  • Allergy and Asthma Clinic of Northwest Arkansas

    Bentonville, Arkansas, 72712, United States

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio, 45236, United States

  • Chronicle Bio

    West Valley City, Utah, 84119, United States

  • Clinique Spécialisée en Allergie de la Capitale

    Québec, G1V 4W2, Canada

  • Donald Levy M.D.

    Orange, California, 92868, United States

  • HZRM Hämophilie Zentrum Rhein Main GmbH

    Frankfurt, 60596, Germany

  • Hautklinik und Poliklinik der Universitätsklinik Mainz

    Mainz, 55131, Germany

  • McMaster University-Hamilton

    Hamilton, Ontario, ON L8N3Z5, Canada

  • Montreal Clinical Research Institute

    Montreal, Quebec, QC H2W 1R7, Canada

  • Raffi Tachdjian MD, Inc.

    Santa Monica, California, 90404, United States

  • Research Solutions of Arizona

    Litchfield Park, Arizona, 85340, United States

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