A Study of Lu AF82422 in Participants With Multiple System Atrophy

NCT05104476 ↗

Phase 2 Active not recruiting 64 enrolled H. Lundbeck A/S

RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start: 2021-11-16
Primary completion: 2023-11-16
Completion: 2028-03-07

Outcome

Missed primary endpoint

paper the primary endpoint was not met. PMID 42044642 ↗

paper The Bayesian probability of 89·4% for a true slowing of clinical disease progression did not reach the predefined threshold of 97·5% PMID 42044642 ↗

Publications

Kjaersgaard L, Wiedemann J, Singer W, Takeda A, Berger AK, Flensburg MF, Hansen L, Kallunki P, Kompus K, Nighah K, Schmidt SN, Jorgensen MN, Svanholm Fogh B, Zanigni S, Luthman J; AMULET Trial Group. Safety and efficacy of the anti-alpha-synuclein monoclonal antibody amlenetug for the treatment of patients with multiple system atrophy (AMULET): a phase 2, randomised, double-blind, multicentre trial. Lancet Neurol. 2026 Jun;25(6):560-570. doi: 10.1016/S1474-4422(26)00100-6. Epub 2026 Apr 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlenetug	Monoclonal antibody	—	Intravenous