Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial.

Aged Antibodies, Monoclonal, Humanized / adverse effects Double-Blind Method Female Humans Male Pneumonia / etiology Supranuclear Palsy, Progressive / drug therapy Treatment Outcome tau Proteins / immunology

Journal

Nature medicine

ISSN: 1546-170X

Titre abrégé: Nat Med

Pays: United States

ID NLM: 9502015

Informations de publication

Date de publication:
08 2021

Historique:

received: 19 12 2020

accepted: 28 06 2021

pubmed: 14 8 2021

medline: 18 9 2021

entrez: 13 8 2021

Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1038/s41591-021-01455-x PMID: 34385707

pubmed: 34385707

doi: 10.1038/s41591-021-01455-x

pii: 10.1038/s41591-021-01455-x

doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0

MAPT protein, human 0

tau Proteins 0

gosuranemab 09FZ7Q0PQZ

Banques de données

ClinicalTrials.gov

['NCT03068468']

Types de publication

Clinical Trial, Phase II Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1451-1457

Commentaires et corrections

Type : CommentIn

Type : ErratumIn

Informations de copyright

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