A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA) (NCT06706622) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)
United States401 participantsStarted 2024-12-03
Plain-language summary
The main goal of this trial is to evaluate the efficacy and safety of amlenetug for the treatment of participants with Multiple System Atrophy (MSA).
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (that is, 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 amlenetug.
* The participant has taken any active IMP within 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/…
What they're measuring
1
Rest of the World (RoW; All Countries Except European Union [EU] and Japan [JP]) Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression
Timeframe: Baseline up to Week 72
2
EU and JP Regional-specific Outcome Measure: Mortality-adjusted Clinical Progression