Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Identifieur interne : 000004 ( France/Analysis ); précédent : 000003; suivant : 000005Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Auteurs : Vincent Meininger [France] ; Angela Genge [Canada] ; Leonard H. Van Den Berg [Pays-Bas] ; Wim Robberecht [Belgique] ; Albert Ludolph [Allemagne] ; Adriano Chio [Italie] ; Seung H. Kim [Corée du Sud] ; P Nigel Leigh [Royaume-Uni] ; Matthew C. Kiernan [Australie] ; Jeremy M. Shefner [États-Unis] ; Claude Desnuelle [France] ; Karen E. Morrison [Royaume-Uni] ; Susanne Petri [Allemagne] ; Diane Boswell [Royaume-Uni] ; Jane Temple [Royaume-Uni] ; Rajat Mohindra [Royaume-Uni] ; Matt Davies [Royaume-Uni] ; Jonathan Bullman [Royaume-Uni] ; Paul Rees [Royaume-Uni] ; Arseniy Lavrov [Royaume-Uni]Source :
- The Lancet. Neurology [ 1474-4465 ] ; 2017.
Abstract
Neurite outgrowth inhibitor A (Nogo-A) is thought to have a role in the pathophysiology of amyotrophic lateral sclerosis (ALS). A monoclonal antibody against Nogo-A showed a positive effect in the SOD1(G93A) mouse model of ALS, and a humanised form of this antibody (ozanezumab) was well tolerated in a first-in-human trial. Therefore, we aimed to assess the safety and efficacy of ozanezumab in patients with ALS.
DOI: 10.1016/S1474-4422(16)30399-4
PubMed: 28139349
Affiliations:
- Allemagne, Australie, Belgique, Canada, Corée du Sud, France, Italie, Pays-Bas, Royaume-Uni, États-Unis
- Angleterre, Arizona, Bade-Wurtemberg, Basse-Saxe, District de Tübingen, Midlands de l'Ouest, Piémont, Provence-Alpes-Côte d'Azur, Sussex de l'Est, Utrecht (province), Île-de-France
- Birmingham, Brighton, Falmer, Hanovre, Nice, Paris, Séoul, Turin, Ulm, Utrecht
- Université d'Ulm, Université de Birmingham, Université du Sussex
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pubmed:28139349Le document en format XML
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</author>
<author><name sortKey="Boswell, Diane" sort="Boswell, Diane" uniqKey="Boswell D" first="Diane" last="Boswell">Diane Boswell</name>
<affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea>
<wicri:noRegion>Uxbridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name>
<affiliation wicri:level="1"><nlm:affiliation>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>R&D Projects Clinical Platforms and Sciences, Quantitative Sciences, Clinical Statistics, GlaxoSmithKline, Uxbridge</wicri:regionArea>
<wicri:noRegion>Uxbridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mohindra, Rajat" sort="Mohindra, Rajat" uniqKey="Mohindra R" first="Rajat" last="Mohindra">Rajat Mohindra</name>
<affiliation wicri:level="1"><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge</wicri:regionArea>
<wicri:noRegion>Uxbridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Davies, Matt" sort="Davies, Matt" uniqKey="Davies M" first="Matt" last="Davies">Matt Davies</name>
<affiliation wicri:level="1"><nlm:affiliation>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Uxbridge</wicri:regionArea>
<wicri:noRegion>Uxbridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bullman, Jonathan" sort="Bullman, Jonathan" uniqKey="Bullman J" first="Jonathan" last="Bullman">Jonathan Bullman</name>
<affiliation wicri:level="1"><nlm:affiliation>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage</wicri:regionArea>
<wicri:noRegion>Stevenage</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name>
<affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea>
<wicri:noRegion>Uxbridge</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lavrov, Arseniy" sort="Lavrov, Arseniy" uniqKey="Lavrov A" first="Arseniy" last="Lavrov">Arseniy Lavrov</name>
<affiliation wicri:level="1"><nlm:affiliation>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge, UK. Electronic address: arseniy.j.lavrov@gsk.com.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Neurosciences Therapy Area Unit, GlaxoSmithKline, Uxbridge</wicri:regionArea>
<wicri:noRegion>Uxbridge</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">The Lancet. Neurology</title>
<idno type="eISSN">1474-4465</idno>
<imprint><date when="2017" type="published">2017</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Neurite outgrowth inhibitor A (Nogo-A) is thought to have a role in the pathophysiology of amyotrophic lateral sclerosis (ALS). A monoclonal antibody against Nogo-A showed a positive effect in the SOD1(G93A) mouse model of ALS, and a humanised form of this antibody (ozanezumab) was well tolerated in a first-in-human trial. Therefore, we aimed to assess the safety and efficacy of ozanezumab in patients with ALS.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>Corée du Sud</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Arizona</li>
<li>Bade-Wurtemberg</li>
<li>Basse-Saxe</li>
<li>District de Tübingen</li>
<li>Midlands de l'Ouest</li>
<li>Piémont</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Sussex de l'Est</li>
<li>Utrecht (province)</li>
<li>Île-de-France</li>
</region>
<settlement><li>Birmingham</li>
<li>Brighton</li>
<li>Falmer</li>
<li>Hanovre</li>
<li>Nice</li>
<li>Paris</li>
<li>Séoul</li>
<li>Turin</li>
<li>Ulm</li>
<li>Utrecht</li>
</settlement>
<orgName><li>Université d'Ulm</li>
<li>Université de Birmingham</li>
<li>Université du Sussex</li>
</orgName>
</list>
<tree><country name="France"><region name="Île-de-France"><name sortKey="Meininger, Vincent" sort="Meininger, Vincent" uniqKey="Meininger V" first="Vincent" last="Meininger">Vincent Meininger</name>
</region>
<name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name>
</country>
<country name="Canada"><noRegion><name sortKey="Genge, Angela" sort="Genge, Angela" uniqKey="Genge A" first="Angela" last="Genge">Angela Genge</name>
</noRegion>
</country>
<country name="Pays-Bas"><region name="Utrecht (province)"><name sortKey="Van Den Berg, Leonard H" sort="Van Den Berg, Leonard H" uniqKey="Van Den Berg L" first="Leonard H" last="Van Den Berg">Leonard H. Van Den Berg</name>
</region>
</country>
<country name="Belgique"><noRegion><name sortKey="Robberecht, Wim" sort="Robberecht, Wim" uniqKey="Robberecht W" first="Wim" last="Robberecht">Wim Robberecht</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Ludolph, Albert" sort="Ludolph, Albert" uniqKey="Ludolph A" first="Albert" last="Ludolph">Albert Ludolph</name>
</region>
<name sortKey="Petri, Susanne" sort="Petri, Susanne" uniqKey="Petri S" first="Susanne" last="Petri">Susanne Petri</name>
</country>
<country name="Italie"><region name="Piémont"><name sortKey="Chio, Adriano" sort="Chio, Adriano" uniqKey="Chio A" first="Adriano" last="Chio">Adriano Chio</name>
</region>
</country>
<country name="Corée du Sud"><noRegion><name sortKey="Kim, Seung H" sort="Kim, Seung H" uniqKey="Kim S" first="Seung H" last="Kim">Seung H. Kim</name>
</noRegion>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Leigh, P Nigel" sort="Leigh, P Nigel" uniqKey="Leigh P" first="P Nigel" last="Leigh">P Nigel Leigh</name>
</region>
<name sortKey="Boswell, Diane" sort="Boswell, Diane" uniqKey="Boswell D" first="Diane" last="Boswell">Diane Boswell</name>
<name sortKey="Bullman, Jonathan" sort="Bullman, Jonathan" uniqKey="Bullman J" first="Jonathan" last="Bullman">Jonathan Bullman</name>
<name sortKey="Davies, Matt" sort="Davies, Matt" uniqKey="Davies M" first="Matt" last="Davies">Matt Davies</name>
<name sortKey="Lavrov, Arseniy" sort="Lavrov, Arseniy" uniqKey="Lavrov A" first="Arseniy" last="Lavrov">Arseniy Lavrov</name>
<name sortKey="Mohindra, Rajat" sort="Mohindra, Rajat" uniqKey="Mohindra R" first="Rajat" last="Mohindra">Rajat Mohindra</name>
<name sortKey="Morrison, Karen E" sort="Morrison, Karen E" uniqKey="Morrison K" first="Karen E" last="Morrison">Karen E. Morrison</name>
<name sortKey="Rees, Paul" sort="Rees, Paul" uniqKey="Rees P" first="Paul" last="Rees">Paul Rees</name>
<name sortKey="Temple, Jane" sort="Temple, Jane" uniqKey="Temple J" first="Jane" last="Temple">Jane Temple</name>
</country>
<country name="Australie"><noRegion><name sortKey="Kiernan, Matthew C" sort="Kiernan, Matthew C" uniqKey="Kiernan M" first="Matthew C" last="Kiernan">Matthew C. Kiernan</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Arizona"><name sortKey="Shefner, Jeremy M" sort="Shefner, Jeremy M" uniqKey="Shefner J" first="Jeremy M" last="Shefner">Jeremy M. Shefner</name>
</region>
</country>
</tree>
</affiliations>
</record>
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