Lundbeck announces completion of patient randomization in the Phase 3 MASCOT trial evaluating amlenetug, a potential first-in-class therapy targeting α-synuclein in multiple system atrophy (MSA).
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Lundbeck A/S has announced the completion of patient randomization in the global Phase 3 MASCOT trial (NCT06706622), evaluating the investigational monoclonal antibody amlenetug in people with multiple system atrophy (MSA), a rare and rapidly progressing neurodegenerative disorder with no approved disease-modifying treatments.
The final patient was randomized earlier than expected, reflecting strong engagement from the global MSA community and accelerating progress in the development of potential therapies for this high unmet medical need.
The multicenter study is currently being conducted across North America, Europe, Asia, and Australia to assess whether amlenetug can slow clinical disease progression in patients with MSA.
Professor Günter Höglinger, lead investigator of the MASCOT trial, described the milestone as an important step for the field, noting that advancing a potential treatment for this underserved disease addresses a critical gap for patients living with MSA.
Amlenetug is designed to target α-synuclein, a protein believed to play a central role in the development of MSA. By binding to extracellular α-synuclein and inhibiting its spread between brain cells, the therapy aims to interfere with a key disease mechanism and could potentially become a first-in-class treatment for the condition.
According to Johan Luthman, Executive Vice President and Head of Research and Development at Lundbeck, the completion of randomization positions the program to continue advancing toward a potential new treatment option for patients affected by this devastating disease.
The investigational therapy has received Orphan Drug Designation in the United States, European Union, and Japan, as well as Fast Track designation in the U.S. and SAKIGAKE designation in Japan, highlighting regulatory support for its development in this rare condition.
With enrollment now complete, participants in the MASCOT trial will continue through the 72-week double-blind treatment phase, where they receive either high-dose amlenetug, low-dose amlenetug, or placebo. This period will be followed by an optional open-label extension, allowing all participants to receive the investigational therapy.
Amlenetug remains an investigational drug and has not been approved by any regulatory authority worldwide.
References
Lundbeck announces last patient randomized ahead-of-schedule in Phase 3 MASCOT trial, 09 March 2026, Lundbeck announces last patient randomized ahead-of-schedule in Phase 3 MASCOT trial – H. Lundbeck A/S
A Trial of Amlenetug (Lu AF82422) in Participants with Multiple System Atrophy (MSA) (MASCOT), ClinicalTrials.gov ID NCT06706622, https://clinicaltrials.gov/study/NCT06706622
About the Writer
Chikkula Pavan Kumar, Pharm.D.
He is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.