Safety Study of Switching from Current Treatment to Garadacimab in Patients Age 12 and Older with Hereditary Angioedema

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What is this study about?

This study focuses on Hereditary Angioedema (HAE), a rare genetic condition that causes sudden episodes of swelling in various parts of the body. The study will evaluate a medication called garadacimab (also known as CSL312), which is given as an injection under the skin. The research aims to assess the safety of switching to garadacimab from other currently used preventive treatments for HAE.

The medication will be administered as a subcutaneous injection with doses up to 400 milligrams per day. The study will involve people who are currently using other preventive treatments for HAE and will monitor how their body responds when switching to garadacimab. The treatment period will last for approximately 3 months.

During the study, participants will receive regular doses of garadacimab, and their health will be closely monitored for any side effects or reactions to the medication. The study will also measure how much of the medication remains in the blood and whether the body produces antibodies against it. Additionally, participants will have the opportunity to share their experience with the new medication compared to their previous treatment.

1 Initial qualification

If you are 12 years or older and have been diagnosed with Hereditary Angioedema (HAE), you may be eligible for this study.

You must have been using lanadelumab, berotralstat, or pdC1INH for HAE prevention at a stable dose for at least 3 months.

Your medical records must confirm your HAE diagnosis through specific laboratory tests.

2 Treatment transition

You will switch from your current HAE prevention medication to garadacimab.

Garadacimab will be administered as an injection under the skin (subcutaneous injection).

3 Monitoring period

Your response to garadacimab will be monitored throughout the study.

Medical staff will track any side effects or reactions that may occur.

Blood samples will be collected to measure garadacimab levels in your body.

The study will check for antibodies your body might develop against garadacimab.

4 Study duration

The study is scheduled to run from August 2025 to June 2026.

During this time, you will be monitored for any changes in your condition and any side effects.

5 Study completion

At the end of the study, you will be asked about your preference regarding garadacimab treatment.

The medical team will evaluate all collected data about your response to the treatment and any side effects.

Who Can Join the Study?

  • Must be at least 12 years old when giving consent to participate in the study
  • Must have previously responded well to treatments for sudden HAE attacks (episodes of swelling)
  • Must have documented medical records showing one of these conditions:
    • A history of swelling episodes without itching or hives
    • Low levels of C1INH (a blood protein) – less than 50% of normal
    • Low levels of C4 protein in blood tests
    • For specific genetic types of HAE: must have confirmed genetic mutations in either FXII or PLG genes, with normal C1INH levels
  • Must be currently using one of these preventive treatments for at least 3 months before screening:
    • Lanadelumab
    • Berotralstat
    • pdC1INH (plasma-derived C1 inhibitor)
  • Must be taking a stable and consistent dose of their current preventive treatment

Who Cannot Join the Study?

  • Persons younger than 12 years old cannot participate in the study
  • Individuals who are not currently using approved treatments for hereditary angioedema (HAE)
  • Patients who are not currently using either KK inhibitor (a type of medication that helps prevent swelling) or pdC1INH (a protein replacement therapy) for HAE prevention
  • Pregnant women or those planning to become pregnant during the study period
  • People with severe allergic reactions to similar medications in the past
  • Individuals participating in other clinical trials
  • Patients with uncontrolled medical conditions that could interfere with the study
  • People unable to follow study procedures or attend scheduled visits
  • Individuals with known substance abuse problems
  • Patients who have received experimental treatments within the past 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
HZRM Haemophilie-Zentrum Rhein Main GmbH Mörfelden-Walldorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.08.2025

Trial locations

Investigated drugs:

Garadacimab (also known as CSL312) is a medication being studied for the treatment of Hereditary Angioedema (HAE). It is designed to prevent HAE attacks in patients who are currently using other preventive treatments. This medication works by targeting specific proteins in the body that are involved in causing swelling episodes in HAE patients.

Plasma-derived C1 inhibitor (pdC1INH) is a medication made from human blood plasma that helps prevent swelling attacks in people with HAE. It works by replacing the missing or malfunctioning C1 inhibitor protein in patients with HAE.

Kallikrein inhibitors (KK inhibitors) are medications that work by blocking a specific protein called kallikrein, which is involved in causing swelling in HAE patients. These medications help prevent HAE attacks by reducing the activity of this protein in the body.

Hereditary Angioedema (HAE) – A rare genetic condition that causes sudden episodes of swelling in various parts of the body, including the hands, feet, face, intestinal walls, and airways. The swelling occurs because of a problem with a blood protein called C1 inhibitor, which normally helps regulate blood vessel function. Episodes of swelling can happen spontaneously or be triggered by stress, injury, or certain medications. The swelling typically develops slowly over several hours and can last for a few days. During an attack, the affected area may feel stretched, painful, and warm to the touch. Between episodes, people with HAE typically have no visible signs of the condition.

Trial ID:
2024-517757-27-00
Protocol code:
CSL312_4002
NCT ID:
NCT06806657
Trial Phase:
Therapeutic confirmatory (Phase III)

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