APRIL : A double-blind, placebo-controlled, randomized, Phase Ib/IIa clinical study of ApTOLL for the treatment of acute ischemic stroke
Hernández-Jiménez, Macarena (AptaTargets (Madrid))
Abad-Santos, Francisco (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas)
Cotgreave, Ian (Research Institutes of Sweden)
Gallego, Jaime (Neurological Center of Navarra)
Jilma, Bernd (Medical University of Vienna)
Flores, Alan (Hospital Universitari Joan XXIII de Tarragona)
Jovin, Tudor G. (Cooper Neurological Institute)
Vivancos, José (Hospital Universitario de la Princesa (Madrid))
Molina, Carlos A. (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Montaner, Joan (Hospital Universitario Virgen Macarena (Sevilla, Andalusia))
Casariego, Joaquín (Aldebaran Health Intelligence (Madrid))
Dalsgaard, Mads (Cureteq AG)
Hernández-Pérez, María (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Liebeskind, David S. (UCLA Stroke Center)
Cobo, Erik (Universitat Politècnica de Catalunya. BarcelonaTech)
Ribo, Marc (Hospital Universitari Vall d'Hebron)
Universitat Autònoma de Barcelona

Date:	2023
Abstract:	In the reperfusion era, a new paradigm of treating patients with endovascular treatment (EVT) and neuroprotective drugs is emerging as a promising therapeutic option for patients with acute ischemic stroke (AIS). In this context, ApTOLL, a Toll-like receptor 4 (TLR4) antagonist with proven neuroprotective effect in preclinical models of stroke and a very good pharmacokinetic and safety profile in healthy volunteers, is a promising first-in-class aptamer with the potential to address this huge unmet need. This protocol establishes the clinical trial procedures to conduct a Phase Ib/IIa clinical study (APRIL) to assess ApTOLL tolerability, safety, pharmacokinetics, and biological effect in patients with AIS who are eligible for EVT. This will be a multicenter, double-blind, randomized, placebo-controlled, Phase Ib/IIa clinical study to evaluate the administration of ApTOLL together with EVT in patients with AIS. The study population will be composed of men and non-pregnant women with confirmed AIS with a <6h window from symptoms onset to ApTOLL/placebo administration. The trial is currently being conducted and is divided into two parts: Phase Ib and Phase IIa. In Phase Ib, 32 patients will be allocated to four dose ascending levels to select, based on safety criteria, the best two doses to be administered in the following Phase IIa in which 119 patients will be randomized to three arms of treatment (dose A, dose B, and placebo).
Grants:	Ministerio de Ciencia, Innovación y Universidades RTC-2017-6651-1 Ministerio de Ciencia, Innovación y Universidades RTC-2019-006795-1
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Clinical trial ; Stroke ; Aptamer ; Inflammation ; Neuroprotection ; ApTOLL ; TLR4
Published in:	Frontiers in neurology, Vol. 14 (february 2023) , ISSN 1664-2295

DOI: 10.3389/fneur.2023.1127585
PMID: 36908619

11 p, 946.8 KB

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