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Active, not recruiting Phase 3

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

NCT06706622 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2024-12-03
Last updated
2026-10-14

Condition(s) studied

Multiple System Atrophy

Investigational drug(s) / intervention(s)

Amlenetug →Placebo

Amlenetug: Solution for infusion

Placebo: Commercially available saline solution

Study summary

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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Rest of the World (RoW; All Countries Except European Union [EU] and Japan [JP]) Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression — 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).
  • EU and JP Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression — 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).

Trial sites (74)

FacilityCityRegionStatus
Mayo Clinic - Vascular Center - Arizona Phoenix Arizona
University of Arkansas for Medical Sciences (UAMS) - Medical Center Little Rock Arkansas
University of California San Francisco - Sandler Neurosciences Center San Francisco California
CenExel CBH - CenExel Rocky Mountain Clinical Research (CenExel RMCR) (Rocky Mountain Movement Di... Englewood Colorado
Yale New Haven Health System New Haven Connecticut
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida
University of Florida-College of Medicine - Gainesville Gainesville Florida
Indiana University (IU) Health-Senior Health Center Indianapolis Indiana
Johns Hopkins University School of Medicine - The Johns Hopkins Multiple Sclerosis (MS) Center Baltimore Maryland
Brigham and Women's Hospital (BWH) Boston Massachusetts
Harvard Medical School - Beth Israel Deaconess Medical Center (BIDMC) - West Campus Boston Massachusetts
QUEST Research Institute Farmington Michigan
Mayo Clinic - Children's Center - Rochester Rochester Minnesota
University of Nebraska Medical Center (UNMC) - The Lied Transplant Center Omaha Nebraska
NYU Langone Health (NYU Langone Medical Center) New York New York
Columbia University Irving Medical Center - The Neurological Institute of New York New York New York
Cleveland Clinic - Neurological Institute - Cerebrovascular Center Cleveland Ohio
University of Pennsylvania - Penn Comprehensive Neuroscience Center Philadelphia Pennsylvania
University of Pittsburgh Medical Center-Magee-Womens Hospital (MWH) Pittsburgh Pennsylvania
Vanderbilt University Medical Center (VUMC) - Vanderbilt Orthopaedic Institute-Nashville Nashville Tennessee
University of Texas Southwestern Medical Center (UT Southwestern Medical Center) Dallas Texas
Baylor College of Medicine (BCM) Houston Texas
Inland Northwest Research (INWR) Spokane Washington
University of New South Wales-Liverpool Hospital - Liverpool Cancer Therapy Centre Liverpool New South Wales
Westmead Hospital Westmead New South Wales
Gold Coast University Hospital (GCUH) (Gold Coast Hospital) Southport Queensland
The Alfred Hospital Melbourne Victoria
The Ottawa Hospital - Centre for Rehabilitation Research and Development (CRRD) (The Institute fo... Ottawa Ontario
University Health Network-Toronto Western Hospital - Krembil Neuroscience Centre (KNC) Toronto Ontario
Centre Hospitalier Universitaire de Rennes-Hopital Pontchaillou Rennes Brittany Region
Centre Hospitalier Universitaire de Lille (CHU Lille) - Centre Regional de Pharmacovigilance (CRPV) Lille Hauts-de-France
Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin - Tripode Bordeaux New Aquitaine
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) Montpellier Occitanie
Centre Hospitalier Universitaire de Toulouse-Hopital Purpan Toulouse Occitanie
AP-HM- Hôpital de La Timone Marseille France
CHU de la Pitié-Salpêtrière Paris France
Universitaetsklinikum Tuebingen - Universitaetsklinik fuer Psychiatrie und Psychotherapie Tübingen Baden-Wurttemberg
Universitaetsklinikum Erlangen - Psychiatrische und Psychotherapeutische Klinik Erlangen Bavaria
Curiositas Ad Sanum - Haag In Oberbayern Haag I.Ob Bavaria
Ludwig-Maximilians-Universitaet Muenchen (LMU) - Klinik und Poliklinik fuer Frauenheilkunde und G... Munich Bavaria

+ 34 more sites — see the full list on the official registry below.

More H. Lundbeck A/S trials in Japan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06706622 on ClinicalTrials.gov ↗ ← All trials in Japan