Interventional, randomized, double-blind, placebo-controlled, optional open-label extension trial of Lu AF82422 in participants with Multiple System Atrophy

Multiple System Atrophy

Please refer Protocol for information related to primary end points as considered company confidential information by the sponsor, Please refer Protocol for information related to primary end points as considered company confidential information by the sponsor

Non-EU regional-specific : slowing in clinical progression, as assessed by changes from baseline up to Week 72 in UMSARS TS, Non-EU regional-specific : Change from baseline to Week 72 in UMSARS TS, EU regional-specific: Change from baseline to Week 72 in UMSARS TS, Global Endpoints: slowing in clinical progression, as assessed by changes from baseline up to Week 72 in UMSARS Part I score, Global Endpoints: slowing in clinical progression, as assessed by changes from baseline up to Week 72 in UMSARS Part II score, Global Endpoints: change from baseline to Week 72 in mUMSARS, UMSARS Part I and UMSARS Part II, Global Clinical Impression: change from baseline to Week 72 in CGI-S score, Global Clinical Impression: change from baseline to Week 72 in PGI-S score, Global Clinical Impression: change from baseline to Week 72 in OGI-S score, Global Disability: change from baseline to Week 72 in UMSARS Part IV score, Functionality: change from baseline to Week 72 in SE-ADL score, Disease Milestones: change from baseline to Week 72 in UMSARS Part I item 1: Speech, Health-related Quality of Life: change from baseline to Week 72 in EQ-5D-5L domain and VAS scores, Health-related Quality of Life: change from baseline to Week 72 in MSA-QoL domain scores, Overall survival: combined clinical progression and survival: joint-rank score based on change from baseline in mUMSARS at Week 72 or time-to-death, whichever comes first, Overall survival: time from baseline to death (any cause), Clinical meaningfulness: response, defined as an absolute increase in mUMSARS score of <5, <7, and <9 points at Week 72, Clinical meaningfulness: response, defined as an absolute increase in UMSARS TS of <16, <21, and <26 points at Week 72, MRI biomarkers: percentage change from baseline to Week 72 in brain volume in brain ROIs; primary ROIs: pons and cerebellum; secondary ROIs: caudate nucleus, putamen, brain stem and total grey matter, as measured using vMRI, Pharmacokinetics: exposure to Lu AF82422 (expressed as plasma concentrations, AUC, and Cmax), Safety placebo-controlled period: TEAEs (treatment-emergent adverse events), Safety placebo-controlled period: actual values and changes from baseline and Week 72 to Week 144 in clinical safety laboratory test values, and vital signs, Safety placebo-controlled period: PCS clinical safety laboratory test values, vital signs, and weight changes, Safety placebo-controlled period: suicidal ideation and behaviour based on the C-SSRS, Safety OLE period: TEAEs (treatment-emergent adverse events), Safety OLE period: actual values and changes from baseline and Week 72 to Week 144 in clinical safety laboratory test values, and vital signs, Safety OLE period: PCS clinical safety laboratory test values, and vital signs, Safety OLE period: suicidal ideation and behaviour based on the C-SSRS, Immunogenicity: development of anti-Lu AF82422 antibodies (ADAs) and titration of ADA-positive samples during the placebo-controlled period and OLE

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