Evaluating Lu AF82422 for treating Multiple System Atrophy

Interventional, Randomized, Double-blind, Placebo-controlled, Optional Open-label Extension Trial of Lu AF82422 in Participants With Multiple System Atrophy

This study is testing if a new drug called Lu AF82422 can help people with Multiple System Atrophy feel better and improve their symptoms.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: H. Lundbeck A/S (Industry-sponsored)
• Locations: 17 sites (Englewood, Colorado and 16 other locations)
• Trial ID: NCT06706622 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the efficacy and safety of Lu AF82422 in participants diagnosed with Multiple System Atrophy (MSA). It involves a 3-6 week screening phase followed by a 72-week placebo-controlled period where participants are randomized to receive either a high dose, low dose of Lu AF82422, or a placebo. After this period, there is an optional 72-week open-label extension where all participants will receive Lu AF82422. The treatment is administered through intravenous infusions approximately every four weeks.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with clinically established or probable MSA-P or MSA-C who have experienced motor symptoms for less than five years.

Not a fit: Patients who have previously been treated with Lu AF82422 or those with a survival prognosis of less than three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Multiple System Atrophy.

How similar studies have performed: While this approach is novel for MSA, other studies targeting neurodegenerative disorders with similar methodologies have shown promising results.

Eligibility criteria

Key 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.

Where this trial is running

Englewood, Colorado and 16 other locations

• CenExel Rocky Mountain Clinical Research, LLC — Englewood, Colorado, United States (Recruiting)
• Parkinson's Disease And Movement Disorder Center Of Boca Raton — Boca Raton, Florida, United States (Recruiting)
• University of Florida Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States (Recruiting)
• QUEST Research Institute — Farmington Hills, Michigan, United States (Recruiting)
• University Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
• Columbia University Medical Center - The Neurological Institute of New York — New York, New York, United States (Recruiting)
• Baylor College Of Medicine — Houston, Texas, United States (Recruiting)
• Inland Northwest Research — Spokane, Washington, United States (Recruiting)
• Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
• Curiositas-ad-sanum Beratungs-und Studien GmbH — Haag in Oberbayern, Germany (Recruiting)
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (Recruiting)
• National Hospital Organization Sendai Nishitaga Hospital — Sendai, Miyagi, Japan (Recruiting)
• Tottori University Hospital — Yonago-shi, Tottori, Japan (Recruiting)
• Severance Hospital, Yonsei University Health System — Seoul, Korea, Republic of (Recruiting)
• Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
• Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital Clinic de Barcelona - Institut Clinic de Neurociencies (ICN) — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Email contact via H. Lundbeck A/S

Conditions Multiple System Atrophy; Lu AF82422; MSA; Neurodegenerative Disorder