Lu AF82422 for Multiple System Atrophy

(AMULET Trial)

Recruiting at 25 trial locations

Overseen By Email contact via H. Lundbeck A/S

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lundbeck A/S

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called Lu AF82422 to see if it can slow down the progression of multiple system atrophy (MSA). MSA is a rare and worsening neurological condition, and current treatments may not be effective. The study will compare the new drug to determine its effectiveness.

Research Team

Email contact via H. Lundbeck A/S

Principal Investigator

H. Lundbeck A/S

Eligibility Criteria

This trial is for individuals with multiple system atrophy (MSA) diagnosed within the last 5 years, having motor or autonomic symptoms. They should have a UMSARS Part I score ≤16 and a MoCA score ≥22, indicating certain levels of physical and cognitive function. Participants must be likely to follow the study protocol and not have used other investigational products recently.

Inclusion Criteria

Your UMSARS Part I score is less than or equal to 16, excluding the item about sexual function.

The participant has not received any other Investigational product since the EOoTDBP Visit.

The participant is, in the Investigator's opinion, likely to comply with the protocol.

Exclusion Criteria

I have not been treated with specific Parkinson's disease therapies in the last year.

I have been diagnosed with a movement disorder other than MSA.

I have no significant health issues other than MSA.

Treatment Details

Interventions

• Lu AF82422
• Placebo

Trial Overview The study tests Lu AF82422's effect on disease progression in MSA patients against a placebo. It aims to understand if this drug can slow down the worsening of symptoms associated with MSA, which includes both parkinsonian (MSA-P) and cerebellar types (MSA-C).

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

Participants in the DBP will receive Lu AF82422 matching placebo IV infusion Q4W from Baseline for a minimum 48 weeks up to a maximum 72 weeks.

Group II: Lu AF82422 Experimental Treatment 1 Intervention

Participants in the DBP will receive Lu AF82422 intravenous (IV) infusion every 4 weeks (Q4W) from Baseline for a minimum 48 weeks up to a maximum 72 weeks. In the optional OLE, all participants will receive Lu AF82422 IV infusion starting on Day 1 of the OLE up to week 92.

Lu AF82422 is already approved in United States, European Union, Japan, China for the following indications:

Approved in United States as Lu AF82422 for:

• None approved yet; in Phase III trials for Multiple System Atrophy

Approved in European Union as Lu AF82422 for:

• None approved yet; granted Orphan Drug Designation for Multiple System Atrophy

Approved in Japan as Lu AF82422 for:

• None approved yet; in Phase III trials for Multiple System Atrophy

Approved in China as Lu AF82422 for:

• None approved yet; in Phase I trials for Multiple System Atrophy

Who Is Running the Clinical Trial?

H. Lundbeck A/S

Lead Sponsor

Trials

332

Recruited

78,300+

Charl van Zyl

H. Lundbeck A/S

Chief Executive Officer since 2023

Degree in Medical Biochemistry from the University of Cape Town, South Africa

Johan Luthman

H. Lundbeck A/S

Chief Medical Officer since 2019

MD from the University of Gothenburg, Sweden