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AMLENETUG

Clinical trials are investigating AMLENETUG in people with Multiple System Atrophy (MSA). These studies are looking at whether AMLENETUG can affect clinical progression and how it performs in a Phase 3 setting. The main target population is adults with MSA.

Table of Contents

Trial overview

The available trial is titled “A trial of Lu AF82422 in Participants with Multiple System Atrophy (MSA)” and it studies AMLENETUG in people with Multiple System Atrophy.[1]

The trial is listed as Authorised and is designed to evaluate the efficacy of AMLENETUG on clinical progression in participants with MSA.[1]

Condition and study population

The only condition named in the trial data is Multiple System Atrophy (MSA).[1]

The target population is participants with MSA, which means the study is focused on people who already have this condition.[1]

Study design and phase

This is an interventional study, which means participants receive a study treatment so researchers can observe the effects.[1]

The study is in Phase 3, which is a later stage of testing and usually involves a larger group of participants than early-phase studies.[1]

The planned enrollment is 385 participants, showing that this is a sizable study for a single condition group.[1]

What the trial is measuring

The brief summary says the study is meant to evaluate the efficacy of AMLENETUG on clinical progression.[1]

Efficacy means how well a treatment works in the study setting.[1]

The primary outcome details are not publicly listed because they are described as company confidential information in the source data.[1]

What this means for patients

For patients, this trial means researchers are trying to learn whether AMLENETUG can change how MSA progresses over time.[1]

The study includes a placebo-like comparison treatment listed as commercially available saline solution for infusion, which is an inactive fluid used for comparison in some trials.[1]

Because the public summary is limited, the exact eligibility rules and full outcome plan are only available in the protocol.[1]

Trial ID Phase Condition studied Status Enrollment
2024-517169-18-00 Phase 3 Multiple System Atrophy Authorised 385

FAQ

  • What is being studied in the AMLENETUG trials? The trials are studying AMLENETUG in people with Multiple System Atrophy. The main goal is to evaluate whether it can affect clinical progression.
  • Who can take part in these trials? The trial data show that the target population is participants with Multiple System Atrophy. The exact eligibility rules are in the study protocol.
  • What phase is the AMLENETUG trial? The listed trial is a Phase 3 study. Phase 3 trials are larger studies that help evaluate how well a treatment works in a specific patient group.
  • What condition is AMLENETUG being tested for? AMLENETUG is being tested for Multiple System Atrophy, also called MSA. This is the only condition listed in the trial data.
  • What outcomes are being measured? The primary outcomes are not shared in the public summary because they are marked as company confidential information. The brief summary says the study is focused on clinical progression.

Ongoing Clinical Trials on AMLENETUG

  • Study of Amlenetug for Patients with Multiple System Atrophy

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

Glossary

  • Multiple System Atrophy (MSA): A serious brain and nerve condition that affects movement and body functions. The trial is studying AMLENETUG in people with this condition.
  • Clinical progression: How a disease changes over time, such as getting better, staying the same, or getting worse.
  • Phase 3: A later stage of clinical research. These studies are usually larger and are used to learn more about how well a treatment works and how safe it is in the target group.
  • Interventional study: A study in which participants receive a treatment or intervention so researchers can measure its effects.
  • Enrollment: The number of people planned to join a study.
  • Primary outcome: The main result the researchers want to measure in a trial.
  • Protocol: The detailed study plan that explains how the trial will be run.
  • Authorised: The trial has been approved to start or continue by the relevant authority.
  • Intravenous use: Given through a vein, usually by infusion.
  • Infusion: A treatment given slowly through a needle or tube into a vein.

References

  1. https://clinicaltrials.gov/study/2024-517169-18-00