A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 18331A
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 19

Brief Summary

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

Conditions

Multiple System Atrophy

Keywords

Multiple System Atrophy; Neurodegenerative Disorder; Autonomic Failure

Outcome Measures

Primary Outcomes (1)

• Percentage Slowing of Clinical Progression Based on Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DB Period (DBP)

  The primary endpoint assessed disease progression by a Bayesian repeated measures model on UMSARS TS. Reported here is the estimated slowing (%) of clinical progression in participants receiving Lu AF82422 relative to those receiving placebo. UMSARS is a combined clinician and patient-reported outcome assessment developed to provide a surrogate measure of disease progression in multiple system atrophy (MSA). UMSARS TS was obtained by the sum of the items from Part I and Part II. Part I assesses historical information on symptoms and activities of daily living over the past 2 weeks and Part II consists of a clinical examination of key MSA motor signs and symptoms. UMSARS TS score was the sum of all items and ranged from 0 (no impairment) to 104 (severe impairment). A higher score indicated greater impairment.

  Baseline up to Week 72

Secondary Outcomes (18)

• Change From Baseline in the UMSARS TS at the End of Treatment (EOT) DBP

  Baseline, Weeks 48 and 72

• Change From Baseline in the Modified UMSARS Part I (mUMSARS) Score at the EOT DBP

  Baseline, Weeks 48 and 72

• Change From Baseline in the UMSARS Part I Scores at the EOT DBP

  Baseline, Weeks 48 and 72

• Change From Baseline in the UMSARS Part II Scores at the EOT DBP

  Baseline, Weeks 48 and 72

• Change From Baseline in Schwab and England Activities of Daily Living (SE-ADL) Score at Week 48 in the DBP

  Baseline, Week 48

Study Arms (2)

Lu AF82422

EXPERIMENTAL

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.

Drug: Lu AF82422

Placebo

EXPERIMENTAL

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.

Drug: Placebo

Interventions

Lu AF82422 DRUG

Solution for infusion

Lu AF82422

Placebo DRUG

Solution for infusion

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (19)

The Parkinsons and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

University of California - San Diego

La Jolla, California, 92037, 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

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

Rush University Medical Center, Rush University Cancer Center

Chicago, Illinois, 60612, United States

Location

Endeavor Health - Glenbrook Hospital

Glenview, Illinois, 60026, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Nebraska Medical Center

Omaha, Nebraska, 68198-8440, United States

Location

NYU Langone Health Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center - The Neurological Institute of New York

New York, New York, 10032, United States

Location

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

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University Of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Gifu University Hospital

Gifu, Gifu, 501-1194, Japan

Location

National Hospital Organization Sendai Nishitaga Hospital

Sendai, Miyagi, 982-8555, Japan

Location

MeSH Terms

Conditions

Multiple System Atrophy; Neurodegenerative Diseases; Pure Autonomic Failure

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 3, 2021
• Study Start: November 16, 2021
• Primary Completion: November 16, 2023
• Study Completion (Estimated): March 7, 2028
• Last Updated: April 13, 2026
• Results First Posted: December 27, 2024

Record last verified: 2026-04

Locations

US (16); JP (3)