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Purpose

The main goal of this trial is to evaluate the efficacy and safety of Lu AF82422 for the treatment of participants with Multiple System Atrophy (MSA).

Condition

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 (i.e., 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 Lu AF82422. - The participant has taken any IMP <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' 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lu AF82422 Low Dose 		Participants will receive Lu AF82422 by intravenous infusion
  • Drug: Lu AF82422
    Solution for infusion
    Other names:
    • amlenetug
Experimental
Lu AF82422 High Dose 		Participants will receive Lu AF82422 by intravenous infusion
  • Drug: Lu AF82422
    Solution for infusion
    Other names:
    • amlenetug
Placebo Comparator
Placebo 		Participants will receive commercially available saline solution for infusion
  • Drug: Placebo
    Commercially available saline solution

Recruiting Locations

Mayo Clinic
Scottsdale 5313457, Arizona 5551752 85259

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205

University of California, San Francisco Neurosciences Clinical Research Unit
San Francisco 5391959, California 5332921 94158

CenExel Rocky Mountain Clinical Research, LLC
Englewood 5421250, Colorado 5417618 80113

Yale New Haven Health
North Haven 4839704, Connecticut 4831725 06473

Parkinson's Disease And Movement Disorder Center Of Boca Raton
Boca Raton 4148411, Florida 4155751 33486

University of Florida Norman Fixel Institute for Neurological Diseases
Gainesville 4156404, Florida 4155751 32608

Indiana Health University
Indianapolis 4259418, Indiana 4921868 46202

QUEST Research Institute
Farmington Hills 4992523, Michigan 5001836 48334

Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905

University Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198-8440

Columbia University Medical Center - The Neurological Institute of New York
New York 5128581, New York 5128638 10032-3726

Cleveland Clinic - Neurological Institute
Cleveland 5150529, Ohio 5165418 44195

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19107

University Of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15213

Vanderbilt University Medical Center-Cognitive and Movement Disorders Group
Nashville 4644585, Tennessee 4662168 37232

Baylor College Of Medicine
Houston 4699066, Texas 4736286 77030

Inland Northwest Research
Spokane 5811696, Washington 5815135 99202

More Details

NCT ID
NCT06706622
Status
Recruiting
Sponsor
H. Lundbeck A/S

Study Contact

Email contact via H. Lundbeck A/S
+45 36301311
LundbeckClinicalTrials@Lundbeck.com

Detailed Description

This study will consist of a 3-6-week screening period, a 72-week placebo-controlled period (PCP), and will include a 72-week optional dose-blinded open-label treatment extension (OLE) period. Participants in the PCP will be randomized to Lu AF82422 high dose, Lu AF82422 low dose or placebo (1:1:1). All participants entering the OLE will receive Lu AF82422 during the OLE. Participants will receive intravenous infusions approximately every 4 weeks during both the PCP and OLE.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.