A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) (MASCOT)

June 3, 2026 updated by: H. Lundbeck A/S

Interventional, Randomized, Double-blind, Placebo-controlled, Optional Open-label Extension Trial of Lu AF82422 in Participants With Multiple System Atrophy

The main goal of this trial is to evaluate the efficacy and safety of amlenetug for the treatment of participants with Multiple System Atrophy (MSA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will consist of a screening period of 10 days up to 6 weeks, a 72-week placebo-controlled period (PCP), and will include a 72-week optional open-label treatment extension (OLE) period. Participants in the PCP will be randomized to amlenetug or placebo. All participants entering the OLE will receive amlenetug during the OLE. Participants will receive intravenous infusions approximately every 4 weeks during both the PCP and OLE.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
401

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital - South Western Sydney Local Health District
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Gold Coast Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Research Institute
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital (TWH)
  • France
      • Bordeaux, France, 33076
        • Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin
      • Lille, France, 59037
        • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
      • Marseille, France, 13385
        • CHU - Hospital de la Timone
      • Montpellier, France, 34295
        • Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac
      • Paris, France, 75651
        • Chu De La Pitie-Salpetriere
      • Rennes, France, 35033
        • Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Germany
      • Beelitz-Heilstätten, Germany, 14547
        • Movement Disorders Clinic
      • Erlangen, Germany, 91054
        • Universitaetsklinikum Erlangen
      • Haag in Oberbayern, Germany, 83527
        • Curiositas-ad-Sanum GmbH
      • München, Germany, 81377
        • Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Tübingen, Germany, 72076
        • University Hospital Tuebingen
  • Italy
      • Bologna, Italy, 40139
        • IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta
      • Milan, Italy, 20122
        • Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico
      • Naples, Italy, 80138
        • AOU Universita della Campania Luigi Vanvitelli
      • Pisa, Italy, 56126
        • A.O.U. Pisana-Ospedale S. Chiara
      • Salerno, Italy, 84100
        • Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona
  • Japan
      • Iruma-gun, Japan, 350-0495
        • Saitama Medical University Hospital
      • Niigata, Japan, 9518520
        • Niigata University Medical and Dental Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 465-8620
        • National Hospital Organization Higashinagoya National Hospital
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Gifu University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 982-8555
        • National Hospital Organization Sendai Nishitaga Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Kodaira-shi, Tokyo, Japan, 187-8551
        • National Center Hospital, National Center of Neurology and Psychiatry
    • Tottori
      • Yonago-shi, Tottori, Japan, 683-8504
        • Tottori University Hospital
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 02447
        • Kyung Hee University Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)
      • Barcelona (Spain), Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Madrid, Spain, 28006
        • Hospital Universitario de la Princesa
      • Seville, Spain, 41015
        • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
      • Valencia, Spain, 46026
        • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...
  • United Kingdom
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust
      • London, United Kingdom, WC1N 3BG
        • The National Hospital for Neurology and Neurosurgery
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 5LP
        • Clinical Ageing Reseach Unit
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco Neurosciences Clinical Research Unit
    • Colorado
      • Englewood, Colorado, United States, 80113
        • CenExel Rocky Mountain Clinical Research, LLC
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Yale New Haven Health
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease And Movement Disorder Center Of Boca Raton
      • Gainesville, Florida, United States, 32608
        • University of Florida Norman Fixel Institute for Neurological Diseases
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Health University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • QUEST Research Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198-8440
        • University Nebraska Medical Center
    • New York
      • New York, New York, United States, 10016
        • NYU Medical Center - Dysautonomia center
      • New York, New York, United States, 10032-3726
        • Columbia University Medical Center - The Neurological Institute of New York
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Neurological Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center-Cognitive and Movement Disorders Group
    • Texas
      • Dallas, Texas, United States, 75390-8565
        • University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Spokane, Washington, United States, 99202
        • Inland Northwest Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • The participant has a diagnosis of clinically established multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C), or clinically probable MSA-P or MSA-C, according to the 2022 Movement Disorders Society (MDS) criteria for the diagnosis of MSA at the Screening Visit.
  • The participant had onset of motor MSA symptoms (that is, parkinsonian and/or cerebellar) within 5 years prior to the Screening Visit in the judgement of the investigator.
  • The participant has an anticipated survival of >3 years, in the opinion of the investigator, at the Screening Visit.
  • The participant has suitable peripheral venous access for investigational medicinal product (IMP) administration and blood sampling.
  • The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit.

Exclusion Criteria:

  • The participant has previously been dosed with amlenetug.
  • The participant has taken any active IMP within 3 months or 5 half lives of that product, whichever is longer, prior to the first dose of IMP.
  • The participant has 2 or more first degree relatives with a history of MSA.
  • The participant, if of MSA-P subtype, has unexplained anosmia (not explained by other common causes such as allergic rhinitis or smoking, nasal structural lesions, or nasal surgery) on olfactory testing at the Screening Visit.
  • The participant has evidence (clinically or on magnetic resonance imaging (MRI)) and/or history of any clinically significant disease or condition other than MSA, that is, in the investigator's opinion, likely to affect CNS functioning, e.g., serious neurological disorder, other intracranial or systemic disease.
  • The participant has a current diagnosis of movement disorders that could mimic MSA, e.g., Parkinson's disease, dementia with Lewy bodies, essential tremor, progressive supranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasal degeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, per investigator discretion. Participants who have previously been incorrectly diagnosed with Parkinson's disease will not be excluded.

Other protocol-defined inclusion and exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Participants will receive commercially available saline solution for infusion
Drug: Placebo
Commercially available saline solution
Experimental: Amlenetug
Participants will receive amlenetug by intravenous infusion
Drug: Amlenetug
Solution for infusion
Other Names:
  • Lu AF82422

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rest of the World (RoW; All Countries Except European Union [EU] and Japan [JP]) Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression
Time Frame: Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint modified Unified Multiple System Atrophy Rating Scale (mUMSARS) score and time-to-death (any cause).
Baseline up to Week 72
EU and JP Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression
Time Frame: Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint Unified Multiple System Atrophy Rating Scale (UMSARS) Total Score (TS) and time-to-death (any cause).
Baseline up to Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Patient Global Impression - Severity of Illness (PGI-S) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Observer-reported Global Impression-Severity of Illness (OGI-S) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in UMSARS Part IV Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in UMSARS Part I Item 1: Speech Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in EuroQol 5-dimensions, 5-levels (EQ-5D-5L) Domain Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Questionnaire Domain Scores
Time Frame: Baseline, Week 72
Baseline, Week 72
Combined Clinical Progression and Survival Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Time from Baseline to Death (Any Cause)
Time Frame: Baseline up to Week 72
Baseline up to Week 72
Percentage Change from Baseline in Brain Volume in Brain Regions of Interest (ROIs)
Time Frame: Baseline, Week 72
Baseline, Week 72
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to Week 144
Day 1 up to Week 144
RoW Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression
Time Frame: Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint UMSARS TS and time-to-death (any cause).
Baseline up to Week 72
EU and JP Regional-specific Outcome Measure: Change from Baseline in UMSARS TS
Time Frame: Baseline, Week 72
Baseline, Week 72
RoW Regional-specific Outcome Measure: Change from Baseline in UMSARS TS
Time Frame: Baseline, Week 72
Baseline, Week 72
Mortality-adjusted Clinical Progression
Time Frame: Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint UMSARS Part I and time-to-death (any cause).
Baseline up to Week 72
Mortality-adjusted Clinical Progression
Time Frame: Baseline up to Week 72
Mortality-adjusted clinical progression will be assessed by the composite endpoint UMSARS Part II and time-to-death (any cause).
Baseline up to Week 72
Change from Baseline in mUMSARS Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in UMSARS Part I Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in UMSARS Part II Score
Time Frame: Baseline, Week 72
Baseline, Week 72
Time to Disability
Time Frame: Baseline up to Week 72
Baseline up to Week 72
Number of Participants with an Absolute Increase in mUMSARS Score of <5, <7, and <9 points
Time Frame: Baseline to Week 72
Baseline to Week 72
Number of Participants with an Absolute Increase in UMSARS TS of <16, <21, and <26 Points
Time Frame: Baseline to Week 72
Baseline to Week 72
Area Under the Curve (AUC) of amlenetug
Time Frame: Baseline up to Week 72
Baseline up to Week 72
Maximum Observed Concentration (Cmax) of Amlenetug
Time Frame: Baseline up to Week 72
Baseline up to Week 72
Number of Participants with Anti-amlenetug Antibodies (ADAs)
Time Frame: Baseline up to Week 144
Baseline up to Week 144

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lundbeck A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 3, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20432A
  • 2024-517169-18-00 (Registry Identifier: EU CT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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