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

NCT06706622 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 20432A2024-517169-18-00
• Study Type: interventional
• Target: 401
• Locations: 10 countries
• Sites: 74

Brief 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).

Conditions

Multiple System Atrophy

Keywords

Lu AF82422; MSA; Neurodegenerative Disorder

Outcome Measures

Primary Outcomes (2)

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

  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

  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 Outcomes (27)

• RoW Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression

  Baseline up to Week 72

• EU and JP Regional-specific Outcome Measure: Change from Baseline in UMSARS TS

  Baseline, Week 72

• RoW Regional-specific Outcome Measure: Change from Baseline in UMSARS TS

  Baseline, Week 72

• Mortality-adjusted Clinical Progression

  Baseline up to Week 72

• Mortality-adjusted Clinical Progression

  Baseline up to Week 72

Study Arms (2)

Amlenetug

EXPERIMENTAL

Participants will receive amlenetug by intravenous infusion

Drug: Amlenetug

Placebo

PLACEBO COMPARATOR

Participants will receive commercially available saline solution for infusion

Drug: Placebo

Interventions

Amlenetug DRUG

Solution for infusion

Also known as: Lu AF82422

Amlenetug

Placebo DRUG

Commercially available saline solution

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (74)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

University of California, San Francisco Neurosciences Clinical Research Unit

San Francisco, California, 94158, United States

Location

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, 80113, United States

Location

Yale New Haven Health

North Haven, Connecticut, 06473, United States

Location

Parkinson's Disease And Movement Disorder Center Of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Florida Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location

Indiana Health University

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Nebraska Medical Center

Omaha, Nebraska, 68198-8440, United States

Location

NYU Medical Center - Dysautonomia center

New York, New York, 10016, United States

Location

Columbia University Medical Center - The Neurological Institute of New York

New York, New York, 10032-3726, United States

Location

Cleveland Clinic - Neurological Institute

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University Of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center-Cognitive and Movement Disorders Group

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center ¿ Multiple System Atrophy Clinic

Dallas, Texas, 75390-8565, United States

Location

Baylor College Of Medicine

Houston, Texas, 77030, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Liverpool Hospital - South Western Sydney Local Health District

Liverpool, New South Wales, 2170, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Gold Coast Hospital

Southport, Queensland, 4215, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Western Hospital (TWH)

Toronto, Ontario, M5T 2S8, Canada

Location

Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

Lille, 59037, France

Location

CHU - Hospital de la Timone

Marseille, 13385, France

Location

Centre Hospitalier Regional Universitaire (CHRU) Montpellier - Hopital Saint-Eloi Guy de Chauliac

Montpellier, 34295, France

Location

Chu De La Pitie-Salpetriere

Paris, 75651, France

Location

Unite d'investigation clinique de Neurologie Rez-de-jardin-Bloc Hopital CHU Pontchaillou

Rennes, 35033, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, 31059, France

Location

Movement Disorders Clinic

Beelitz-Heilstätten, 14547, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Curiositas-ad-Sanum GmbH

Haag in Oberbayern, 83527, Germany

Location

Ludwig-Maximilians-Universitat Munchen Klinikum der Universitat - Grosshadern

München, 81377, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

IRCCS Institute of Neurological Sciences of Bologna- Universita di Bologna

Bologna, 40139, Italy

Location

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

Location

AOU Universita della Campania Luigi Vanvitelli

Naples, 80138, Italy

Location

A.O.U. Pisana-Ospedale S. Chiara

Pisa, 56126, Italy

Location

Universita Di Salerno Aou San Giovanni Di Dio E Ruggi D'Aragona

Salerno, 84100, Italy

Location

National Hospital Organization Higashinagoya National Hospital

Nagoya, Aichi-ken, 465-8620, Japan

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

National Hospital Organization Sendai Nishitaga Hospital

Sendai, Miyagi, 982-8555, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Center Hospital, National Center of Neurology and Psychiatry

Kodaira-shi, Tokyo, 187-8551, Japan

Location

Tottori University Hospital

Yonago-shi, Tottori, 683-8504, Japan

Location

Saitama Medical University Hospital

Iruma-gun, 350-0495, Japan

Location

Niigata University Medical And Dental Hospital

Niigata, 9518520, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN)

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona (Spain), 08041, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

Seville, 41015, Spain

Location

Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bu...

Valencia, 46026, Spain

Location

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

Nuffield Oxford University and Oxford University Hospital NHS Foundation Trusts-John Radcliffe Ho...

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Clinical Ageing Reseach Unit

Newcastle upon Tyne, Tyne and Wear, NE4 5LP, United Kingdom

Location

Royal Devon and Exeter Hospital - Royal Devon University Healthcare NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

The National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Multiple System Atrophy; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): February 17, 2028
• Study Completion (Estimated): October 25, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

AU (4); US (23); KR (3); GB (6); JP (11); DE (6); FR (7); CA (2); IT (6); ES (6)