NCT06706622

A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study will consist of a screening period of 10 days up to 6 weeks, a 72-week placebo-controlled period (PCP), and will include a 72-week optional dose-blinded open-label treatment extension (OLE) period. Participants in the PCP will be randomized to amlenetug high dose, amlenetug low dose or placebo (1:1:1). All participants entering the OLE will receive amlenetug during the OLE. Participants will receive intravenous infusions approximately every 4 weeks during both the PCP and OLE.

Conditions

• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	Amlenetug	Solution for infusion
DRUG	Placebo	Commercially available saline solution

Timeline

• Start date: 2024-12-03
• Primary completion: 2028-02-17
• Completion: 2029-10-25
• First posted: 2024-11-26
• Last updated: 2026-02-17

Locations

74 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, Japan, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study