Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Long-term safety study of garadacimab (CSL312) for prevention of hereditary angioedema attacks

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying Hereditary Angioedema, a rare genetic condition that causes severe swelling attacks in different parts of the body. The study examines a new medication called garadacimab (also known as CSL312) that is given as an injection under the skin to prevent these swelling attacks. The purpose is to evaluate how safe and effective this medication is when used for a long time in people who experience regular swelling attacks.

The medication is given as a solution for injection that is administered under the skin (subcutaneous injection). This is a long-term study where participants receive regular treatments with garadacimab to prevent swelling attacks. The study looks at how well the medication works in reducing the number and severity of swelling attacks compared to before treatment.

During the study, researchers track how many swelling attacks occur and how severe they are. They also monitor any side effects that participants may experience while using the medication. The study focuses particularly on seeing if the treatment can significantly reduce the frequency of swelling attacks and improve the quality of life for people with this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive garadacimab as a solution for injection under the skin (subcutaneous injection)

    The treatment aims to prevent hereditary angioedema attacks (sudden swelling episodes that can occur in different parts of your body)

  2. Step 2

    Treatment monitoring

    Medical staff will monitor your response to the treatment by tracking:

    The number and severity of swelling attacks you experience per month

    How often you need additional treatment for sudden attacks

    Your personal assessment of how well the treatment is working

  3. Step 3

    Safety monitoring

    Throughout the study, medical staff will monitor:

    Any side effects that may occur after injections

    Any serious health changes during treatment

    The presence of antibodies your body might develop against the medication

  4. Step 4

    Long-term evaluation

    The study continues until November 2025

    Medical staff will assess:

    The reduction in number of swelling attacks compared to before treatment

    The percentage of patients who achieve significant reduction in attacks

    The overall safety of long-term treatment

Who can join the trial?

5 criteria

  • Must be at least 12 years old (male or female)
  • Must have a confirmed diagnosis of hereditary angioedema (HAE) - a rare genetic condition that causes episodes of severe swelling
  • Must have experienced at least 3 HAE attacks in the 3 months before initial screening
  • For patients who have never used the study medication (CSL312): Must complete a run-in period (initial observation period) of at least 1 month
  • During the run-in period, must have experienced an average of at least 1 HAE attack per month

Who cannot join the trial?

15 criteria

  • Age below 12 years old
  • Known allergic reactions to CSL312 (the study medication) or similar medications
  • Currently pregnant or breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • History of severe allergic reactions or anaphylaxis (a serious, life-threatening allergic reaction)
  • Significant heart, liver, or kidney disease
  • Active cancer or ongoing cancer treatment
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Current use of medications that could interact with the study drug
  • Mental conditions that could affect the ability to follow study procedures
  • Drug or alcohol abuse within the past year
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable or unwilling to comply with study procedures and visits
  • History of serious infections in the past 3 months
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Garadacimab

    (also known as CSL312) is an experimental medication designed for preventing attacks in people with hereditary angioedema (HAE). It works by targeting a specific protein in the body that is involved in swelling episodes. The medication is given as an injection under the skin (subcutaneous injection) and is being studied as a preventive treatment to reduce the frequency of HAE attacks.

  • C1-INH

    (C1 esterase inhibitor) is a protein that helps regulate various body processes including swelling. In people with hereditary angioedema, there is either not enough C1-INH or it doesn't work properly. This trial is studying how garadacimab works in patients with this specific type of HAE related to C1-INH deficiency.

What is already known about the treatment

Garadacimab (CSL312) - A novel investigational medication administered through subcutaneous injection for the prophylactic treatment of Hereditary Angioedema (HAE). This monoclonal antibody works by targeting and inhibiting Factor XIIa, a key protein in the plasma kallikrein-kinin cascade that is responsible for angioedema attacks in HAE patients. Currently undergoing clinical trials to evaluate its long-term safety and efficacy, Garadacimab represents a new approach to HAE management by focusing on preventive treatment rather than acute attack management. The medication belongs to the class of plasma kallikrein inhibitors and is being studied as a potential regular preventive treatment option for patients with C1-inhibitor deficiency hereditary angioedema.

Investigated diseases

Hereditary Angioedema - A rare genetic condition characterized by recurrent episodes of severe swelling in various parts of the body. The swelling typically affects the hands, feet, face, digestive tract, and airways. Episodes can occur spontaneously or be triggered by stress, minor trauma, or other factors. The condition is caused by a deficiency or dysfunction of a blood protein called C1 inhibitor, which helps regulate various body processes. The swelling develops slowly over several hours and usually subsides within 2-5 days. Between episodes, patients may have no visible symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510777-18-00Protocol codeCSL312_3002Estimated enrolment161 patientsSponsorCSL Behring LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.