Abstract Details

Title Study Design of TAK-341-2001: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-341 in Subjects With Multiple System Atrophy

Topic Neuromuscular and Clinical Neurophysiology (EMG)

Presentation(s) P9 - Poster Session 9 (5:30 PM-6:30 PM)

Poster/Presentation
Number 4-003

Objective

To describe the design of a clinical trial that will evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered TAK-341 in participants with multiple system atrophy (MSA).

Background

MSA is a rapidly progressing and fatal neurological disorder, with no treatments that can slow its progression. TAK-341 (MEDI1341) is a monoclonal antibody that binds to the C-terminal region of human alpha-synuclein. In a mouse model, TAK-341 attenuated cell-to-cell spreading of alpha-synuclein pathology in the brain. Single ascending dose (NCT03272165) and multiple ascending dose (NCT04449484) studies in healthy participants and participants with Parkinson disease, respectively, have recently completed and support continued development of TAK-341.

Design/Methods This randomized, double-blind, placebo-controlled, Ph2 study (NCT05526391) will enroll approximately 138 participants globally who are ≥40 years of age, with probable or possible MSA according to modified Gilman 2008 criteria. Participants’ onset of MSA symptoms must have occurred ≤4 years before screening as demonstrated by MSA symptoms measured with the Unified MSA Rating Scale (UMSARS).

Participants will receive 13 intravenous infusions of either TAK-341 or placebo, approximately every 4 weeks. The study comprises a ≤42-day screening period, a 52-week double-blind treatment period, and a follow-up safety visit.

The study’s primary objective is to evaluate the efficacy of TAK-341 versus placebo, as measured by the change from baseline after 52 weeks on a modified UMSARS Part I. Secondary objectives are to evaluate the efficacy of TAK-341 versus placebo, as measured by change from baseline after 52 weeks on the following: UMSARS Part I, Part II, and total scores, an 11-item selection of UMSARS Part I and II items, CGI-S, SCOPA-AUT, and overall survival. Secondary objectives also include evaluation of pharmacokinetic parameters. Safety endpoints will also be evaluated.

Results Recruiting

Conclusions Trial results will yield insight into the role of alpha-synuclein in MSA disease progression, and further inform TAK-341’s risk-benefit profile.

Authors/Disclosures
Jaya Padmanabhan PRESENTER	Jaya Padmanabhan has received personal compensation for serving as an employee of Takeda Pharmaceuticals. Jaya Padmanabhan has stock in Takeda Pharmaceuticals.
Elena Ratti, MD (Takeda)	Dr. Ratti has received personal compensation for serving as an employee of Takeda. Dr. Ratti has received personal compensation for serving as an employee of Biogen. Dr. Ratti has stock in Takeda. Dr. Ratti has stock in Biogen.
	No disclosure on file
Wei Yin	Wei Yin has received personal compensation for serving as an employee of Takeda. Wei Yin has stock in Takeda.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Brian Harel, PhD	Brian Harel, PhD has received personal compensation for serving as an employee of Takeda. An immediate family member of Brian Harel, PhD has received personal compensation for serving as an employee of Astra Zeneca. Brian Harel, PhD has or had stock in Takeda, Merck, Day One Biopharmaceuticals. An immediate family member of Brian Harel, PhD has or had stock in Eli Lilly, Pfizer, Astra Zeneca.Brian Harel, PhD has or had stock in Cogstate.
	No disclosure on file
	No disclosure on file
Craig Shering, Other (AstraZeneca)	Dr. Shering has received personal compensation for serving as an employee of AstraZeneca. An immediate family member of Dr. Shering has received personal compensation for serving as an employee of eResearch Technology Inc. Dr. Shering has stock in AstraZeneca. Dr. Shering has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
Antonio Laurenza, MD (Takeda Pharmacautcals)	Dr. Laurenza has received personal compensation for serving as an employee of Takeda. Dr. Laurenza has stock in Takeda.
Arthur Simen	Arthur Simen has received personal compensation for serving as an employee of Takeda.

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