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Study of Amlenetug for Patients with Multiple System Atrophy

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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 a condition known as Multiple System Atrophy (MSA), a rare neurological disorder that affects the body's involuntary functions, such as blood pressure, breathing, and motor control. The trial will investigate the effects of a treatment called Lu AF82422, also known as Amlenetug, which is a type of protein designed to target specific proteins in the brain. This treatment is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective Lu AF82422 is in slowing down the progression of MSA. Participants in the trial will receive either the treatment or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results. The trial will also include an optional open-label extension, where all participants may have the opportunity to receive the actual treatment after the initial phase.

Throughout the study, participants will be monitored for changes in their condition over a period of time, with assessments taking place up to 72 weeks. These assessments will include various tests and evaluations to measure the impact of the treatment on the symptoms and progression of MSA. The trial aims to provide valuable insights into the potential benefits of Lu AF82422 for individuals living with this challenging condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the participant will be informed about the study's purpose and procedures. The participant will be required to sign an informed consent form, confirming understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes evaluating the participant's medical history, current health status, and specific criteria related to Multiple System Atrophy (MSA).

  3. Step 3

    Randomization and treatment allocation

    Participants will be randomly assigned to receive either the investigational medication, Lu AF82422, or a placebo. This process is double-blind, meaning neither the participant nor the study staff will know which treatment is being administered.

  4. Step 4

    Treatment administration

    The treatment involves the administration of Amlenetug 53 mg/ml solution for infusion through intravenous use. The frequency and duration of administration will be determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    Participants will undergo regular monitoring to assess the treatment's effects and any potential side effects. This includes clinical evaluations, laboratory tests, and imaging studies as specified in the study protocol.

  6. Step 6

    Optional open-label extension

    Participants may have the option to continue in an open-label extension phase, where all participants receive the investigational medication, Lu AF82422, regardless of their initial group assignment.

  7. Step 7

    Completion and final assessment

    Upon completion of the study period, a final assessment will be conducted to evaluate the overall impact of the treatment on the participant's condition. This includes a comprehensive review of all collected data.

Who can join the trial?

16 criteria

  • The participant must be able to communicate with the study staff.
  • The participant must have started experiencing movement-related symptoms of **Multiple System Atrophy (MSA)**, such as **parkinsonian** (related to Parkinson's disease) or **cerebellar** (related to the part of the brain that controls movement) symptoms, within the last 5 years.
  • The participant must be expected to live for more than 3 years, according to the study doctor's opinion.
  • The participant must have a score of 16 or less on a specific part of a test called **UMSARS Part I**, which assesses the severity of MSA symptoms, excluding questions about sexual function.
  • The participant must score 22 or higher on a cognitive test called **MoCA** (Montreal Cognitive Assessment), which checks thinking abilities. If the participant has 12 years or less of formal education, one point can be added to their score.
  • The participant must have good veins for receiving the study medication and for taking blood samples.
  • For male participants, they must either be surgically sterilized, remain sexually abstinent, engage only in same-sex relationships, or have a partner who cannot become pregnant. If their partner can become pregnant, they must use contraception and not donate sperm during the study and for 5 months after the last dose of the study medication.
  • For female participants who can become pregnant, they must remain sexually abstinent, engage only in same-sex relationships, have a sterilized male partner, or use a highly effective method of contraception during the study and for 5 months after the last dose of the study medication. They must also not donate eggs during this time.
  • The participant must be able to read and understand the **Informed Consent Form (ICF)**, which explains the study details.
  • The participant must have signed the study-specific ICF.
  • The participant's caregiver must be able to read and understand the **Caregiver's Informed Consent Form**.
  • The participant's caregiver must have signed the Caregiver's Informed Consent Form.
  • The participant must be between 40 and 75 years old at the time of the screening visit.
  • The participant must have a reliable caregiver who can spend at least 3 hours a week with them and help with study-related tasks.
  • The participant and their caregiver must be willing and able to attend study appointments as scheduled.
  • The participant must have a diagnosis of either **MSA-P** (Multiple System Atrophy with parkinsonian features) or **MSA-C** (Multiple System Atrophy with cerebellar features), according to specific criteria set in 2022.

Who cannot join the trial?

10 criteria

  • Participants who do not have a diagnosis of Multiple System Atrophy cannot join the study. Multiple System Atrophy is a rare condition that affects the nervous system.
  • Individuals who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Participants who are not able to follow the study procedures or attend required visits may be excluded.
  • Individuals with other medical conditions that might interfere with the study or its results may not be eligible.
  • Participants who are currently involved in another clinical trial may not be allowed to join this study.
  • Women who are pregnant or breastfeeding may not be eligible to participate.
  • Individuals who have a history of allergic reactions to the study medication or similar drugs may be excluded.
  • Participants who have a history of substance abuse or dependency may not be eligible.
  • Individuals who have had recent major surgery or are planning to have surgery during the study period may be excluded.
  • Participants who have certain abnormal laboratory test results that could affect the study may not be eligible.
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Investigated drugs

Lu AF82422 is an investigational medication being studied for its potential to slow down the progression of Multiple System Atrophy (MSA). MSA is a rare neurodegenerative disorder that affects the body's involuntary functions, such as blood pressure, breathing, and motor control. This medication is being tested to see if it can help manage the symptoms and improve the quality of life for people with MSA.

What is already known about the treatment

Lu AF82422 – This medication is administered through injection and is currently being studied in clinical trials for its potential use in treating Multiple System Atrophy (MSA). It is not yet widely available in medical practice, as it is still under investigation to determine its effectiveness and safety. The main therapeutic indication for Lu AF82422 is to slow down the clinical progression of MSA, a rare neurodegenerative disorder. At the molecular level, Lu AF82422 is believed to work by targeting specific proteins involved in the disease process, although the exact mechanism is still being researched. It is classified pharmacologically as a monoclonal antibody, which is a type of protein designed to interact with specific targets in the body.

Investigated diseases

Multiple System Atrophy – This is a rare neurological disorder that affects the body's involuntary functions, including blood pressure, breathing, bladder function, and motor control. It is characterized by a combination of symptoms that can resemble Parkinson's disease, such as slow movement, muscle rigidity, and poor balance. As the disease progresses, individuals may experience increasing difficulty with movement and coordination, as well as problems with autonomic functions like blood pressure regulation and bladder control. The progression of symptoms can vary, but they generally worsen over time, leading to significant impairment in daily activities.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517169-18-00Protocol code20432AEstimated enrolment426 patientsSponsorH. Lundbeck A/S

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