Journal Article

DZNE-2021-01399

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.

Dam, T. ; Boxer, A. L. ; Golbe, L. I. ; Höglinger, G.DZNE* ; Morris, H. R. ; Litvan, I. ; Lang, A. E. ; Corvol, J.-C. ; Aiba, I. ; Grundman, M. ; Yang, L. ; Tidemann-Miller, B. ; Kupferman, J. ; Harper, K. ; Kamisoglu, K. ; Wald, M. J. ; Graham, D. L. ; Gedney, L. ; O'Gorman, J. ; Haeberlein, S. B. ; Group, P. S. (Collaboration Author)

2021
Nature America Inc. New York, NY

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Please use a persistent id in citations: doi:10.1038/s41591-021-01455-x

Abstract: A randomized, double-blind, placebo-controlled, 52-week study (no. NCT03068468) evaluated gosuranemab, an anti-tau monoclonal antibody, in the treatment of progressive supranuclear palsy (PSP). In total, 486 participants dosed were assigned to either gosuranemab (n = 321) or placebo (n = 165). Efficacy was not demonstrated on adjusted mean change of PSP Rating Scale score at week 52 between gosuranemab and placebo (10.4 versus 10.6, P = 0.85, primary endpoint), or at secondary endpoints, resulting in discontinuation of the open-label, long-term extension. Unbound N-terminal tau in cerebrospinal fluid decreased by 98% with gosuranemab and increased by 11% with placebo (P < 0.0001). Incidences of adverse events and deaths were similar between groups. This well-powered study suggests that N-terminal tau neutralization does not translate into clinical efficacy.

Keyword(s): Aged (MeSH) ; Antibodies, Monoclonal, Humanized: adverse effects (MeSH) ; Antibodies, Monoclonal, Humanized: therapeutic use (MeSH) ; Double-Blind Method (MeSH) ; Female (MeSH) ; Humans (MeSH) ; Male (MeSH) ; Pneumonia: etiology (MeSH) ; Supranuclear Palsy, Progressive: drug therapy (MeSH) ; Treatment Outcome (MeSH) ; tau Proteins: immunology (MeSH) ; Antibodies, Monoclonal, Humanized ; MAPT protein, human ; tau Proteins ; gosuranemab

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Contributing Institute(s):

1. Clinical Research (Munich) (Clinical Research (Munich))

Research Program(s):

1. 353 - Clinical and Health Care Research (POF4-353) (POF4-353)

Appears in the scientific report 2021

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Clinical Medicine ; Current Contents - Life Sciences ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 80 ; JCR ; Nationallizenz ; SCOPUS ; Science Citation Index Expanded ; Web of Science Core Collection

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Linked articles:

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Journal Article (Erratum/Correction) Dam, T. ; Boxer, A. L. ; Golbe, L. I. ; et al
Author Correction: Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.
Nature medicine 29(11), 2955 - 2956 (2023) [10.1038/s41591-022-02076-8]2023   Files  Fulltext BibTeX | EndNote: XML, Text | RIS

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