A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT ID: NCT05104476

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2028-03-07

Brief Summary

To find out the effect of Lu AF82422 on disease progression in participants with multiple system atrophy.

Detailed Description

This study will consist of a double-blind period (DBP) and will include an optional open-label treatment extension (OLE) period. Participants in the DBP will be randomized to Lu AF82422 or placebo (2:1). All participants entering the OLE will receive Lu AF82422 during the OLE.

Conditions

Multiple System Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lu AF82422

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 188.

Group Type: EXPERIMENTAL

Lu AF82422

Intervention Type: DRUG

Solution for infusion

Placebo

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 Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Solution for infusion

Interventions

Lu AF82422

Solution for infusion

Intervention Type: DRUG

Placebo

Solution for infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant is diagnosed with possible or probable MSA of the multiple system atrophy parkinsonian type (MSA-P) or multiple system atrophy cerebellar type (MSA-C) sub-type at the Screening Visit.
• The participant had onset of motor and/or autonomic (orthostatic or urinary) MSA symptoms within 5 years prior to the Screening Visit in the judgement of the investigator.
• The participant has an UMSARS Part I score ≤16 (omitting item 11 on sexual function) at the Screening Visit.
• The participant has a cognitive performance evaluated by the Montreal Cognitive Assessment (MoCA) with a score ≥22 at the Screening Visit.

Open-label Extension Entry Criteria

• The participant has completed the EoT Visit and did not withdraw in the DBP.
• The participant has consented to participate in the OLE.
• The participant has completed the DBP within the last 5 months and will be enrolled into the OLE no later than end of Q1 2024.
• The participant is, in the Investigator's opinion, likely to comply with the protocol.
• The participant has not received any other Investigational product since the EOoTDBP Visit.

Exclusion Criteria

• The participant has been treated with an anti-α-synuclein monoclonal antibody, mesenchymal stem cells or an inhibitor of α-synuclein aggregation within the last 12 months.
• The participant has any past or current treatment with an active vaccine targeting α-synuclein.
• The participant has 2 or more blood relatives with a history of MSA.
• The participant has evidence (clinically or on MRI) and/or history of any clinically significant disease or condition other than MSA (for example, serious neurological disorder, other intracranial disease, or systemic disease).
• The participant has a current diagnosis of movement disorders that could mimic MSA (for example, 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

The Parkinsons and Movement Disorder Institute

Fountain Valley, California, United States

University of California - San Diego

La Jolla, California, United States

University of California, San Francisco Neurosciences Clinical Research Unit

San Francisco, California, United States

CenExel Rocky Mountain Clinical Research, LLC

Englewood, Colorado, United States

Parkinson's Disease And Movement Disorder Center Of Boca Raton

Boca Raton, Florida, United States

University of Florida Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

Rush University Medical Center, Rush University Cancer Center

Chicago, Illinois, United States

Endeavor Health - Glenbrook Hospital

Glenview, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

University Nebraska Medical Center

Omaha, Nebraska, United States

NYU Langone Health Medical Center

New York, New York, United States

Columbia University Medical Center - The Neurological Institute of New York

New York, New York, United States

Penn State Milton S. Hershey Medical Center - Penn State Hershey Neuroscience Institute (PSHNI)

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University Of Pittsburgh

Pittsburgh, Pennsylvania, United States

Fujita Health University Hospital

Toyoake, Aichi-ken, Japan

Gifu University Hospital

Gifu, Gifu, Japan

National Hospital Organization Sendai Nishitaga Hospital

Sendai, Miyagi, Japan

Countries

United States; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

18331A

Identifier Type: -

Identifier Source: org_study_id