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

Last updated: January 8, 2025
Sponsor: H. Lundbeck A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Multiple System Atrophy

Treatment

Placebo

Lu AF82422

Clinical Study ID

NCT06706622
20432A
2024-517169-18-00
  • Ages 40-75
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • The participant has a diagnosis of clinically established multiple system atrophyparkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C), orclinically 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/orcerebellar) within 5 years prior to the Screening Visit in the judgement of theinvestigator.

  • The participant has an anticipated survival of >3 years, in the opinion of theinvestigator, at the Screening Visit.

  • The participant has suitable peripheral venous access for investigational medicinalproduct (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

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 byother 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, progressivesupranuclear palsy, spinocerebellar ataxia, spastic paraparesis, corticobasaldegeneration, or vascular, pharmacological, or post-encephalitic parkinsonism, perinvestigator discretion. Participants who have previously been incorrectly diagnosedwith Parkinson's disease will not be excluded.

Other protocol-defined inclusion and exclusion criteria apply.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
December 03, 2024
Estimated Completion Date:
October 25, 2029

Study 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.

Connect with a study center

  • CenExel Rocky Mountain Clinical Research, LLC

    Englewood, Colorado 80113
    United States

    Active - Recruiting

  • Parkinson's Disease And Movement Disorder Center Of Boca Raton

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Inland Northwest Research

    Spokane, Washington 99202
    United States

    Active - Recruiting

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