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Study on the Safety and Efficacy of ARGX-119 for Adults with Amyotrophic Lateral Sclerosis (ALS)

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What is this trial about?

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

This clinical trial is focused on studying Amyotrophic Lateral Sclerosis (ALS), a progressive disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and loss of muscle control. The study will evaluate a treatment called ARGX-119, which is a humanized IgG1 monoclonal antibody designed to target a specific protein involved in muscle function. This treatment is administered as a concentrate for solution for infusion, meaning it is given through a vein.

The purpose of the study is to assess the safety and tolerability of ARGX-119 in people with ALS. Participants will be randomly assigned to receive either the treatment or a placebo, which is a substance with no active medication. The study will be conducted in a double-blinded manner, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure the results are unbiased. The study will also include an active-treatment extension phase, allowing researchers to gather more information about the treatment's effects over time.

Throughout the study, participants will undergo various assessments to monitor their health and the effects of the treatment. These assessments will include checking for any adverse events, conducting clinical laboratory tests, and measuring vital signs. The study will also look at how the body processes ARGX-119 and whether the immune system produces any antibodies against it. The trial is expected to continue until 2027, providing valuable insights into the potential benefits and safety of ARGX-119 for individuals with ALS.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the investigational drug ARGX-119 or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

  2. Step 2

    Treatment administration

    The treatment involves receiving ARGX-119, a humanised igg1 monoclonal antibody, or a placebo through an intravenous infusion. The specific dosage and frequency of administration will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, participants will undergo regular monitoring to assess safety and tolerability. This includes checking for any adverse events, conducting clinical laboratory tests, and measuring vital signs and ECGs (electrocardiograms).

  4. Step 4

    Efficacy evaluations

    The study will evaluate the efficacy of ARGX-119 by measuring changes in muscle function over time. This includes assessing the rate of change in motor unit numbers using electrophysiological muscle scans.

  5. Step 5

    Pharmacokinetics and immunogenicity

    The study will also measure how the body processes ARGX-119 over time, known as pharmacokinetics. Additionally, the presence of anti-drug antibodies in the serum will be monitored to understand the immune response to the drug.

  6. Step 6

    Study duration

    The study is expected to continue until April 2027, with recruitment starting in September 2024. Participants will be involved in the study for a specified period, as outlined in the study protocol.

Who can join the trial?

4 criteria

  • The participant must be at least 18 years old and no older than 80 years.
  • The participant must have been diagnosed with **Amyotrophic Lateral Sclerosis (ALS)**, which is a disease that affects the nerve cells in the brain and spinal cord, according to specific guidelines called the Gold Coast criteria.
  • The participant must have a **TRICALS risk profile** score between -6.0 and -2.0. This is a way to measure the risk or progression of ALS.
  • The participant must have a **SVC** (Slow Vital Capacity) of at least 60% of what is expected for their age and size. SVC is a test that measures how much air a person can slowly exhale after taking a deep breath, which helps assess lung function.

Who cannot join the trial?

6 criteria

  • Individuals who do not have a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) cannot participate. ALS is a disease that affects the nerve cells in the brain and spinal cord.
  • Participants must be within a specific age range, typically adults, to be eligible.
  • Both males and females are eligible, but certain health conditions or treatments may exclude participation.
  • Individuals who are part of a vulnerable population, such as those with severe health issues or disabilities, may not be eligible.
  • Participants must not have any other medical conditions or be taking medications that could interfere with the study.
  • Individuals who are unable to comply with the study procedures or follow-up visits may be excluded.
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Investigated drugs

ARGX-119 is a medication being studied for its potential to help people with Amyotrophic Lateral Sclerosis (ALS). The trial aims to understand how safe and tolerable this medication is for patients. Researchers are also looking at how the body processes the medication and whether it triggers any immune response. This study is important because it could lead to new treatments for ALS, a condition that currently has limited options.

What is already known about the treatment

ARGX-119 – This medication is administered intravenously, meaning it is given directly into a vein. Currently, ARGX-119 is being studied in clinical trials, specifically in a Phase 2a study, to assess its safety and effectiveness for treating Amyotrophic Lateral Sclerosis (ALS). The main therapeutic indication for ARGX-119 is ALS, a progressive neurodegenerative disease. At the molecular level, ARGX-119 works by targeting specific proteins involved in the disease process, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational drug, as it is still undergoing research to determine its potential benefits and risks.

Investigated diseases

Amyotrophic Lateral Sclerosis (ALS) – ALS is a progressive neurological disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As these neurons deteriorate, the brain loses the ability to initiate and control muscle movement. This results in muscle weakness and atrophy, often starting in the limbs and eventually affecting speech, swallowing, and breathing. The progression of muscle weakness varies among individuals, but it typically spreads to other parts of the body over time. Despite the loss of muscle function, the disease does not usually affect the senses or cognitive abilities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511318-19-00Protocol codeARGX-119-2303Estimated enrolment60 patientsSponsorArgenx

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