Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.
Identifieur interne : 000401 ( Main/Exploration ); précédent : 000400; suivant : 000402Safety 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.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Analyse de survie, Anticorps monoclonaux humanisés (usage thérapeutique), Coopération internationale, Facteurs de l'âge, Facteurs immunologiques (usage thérapeutique), Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Protéines Nogo (immunologie), Résultat thérapeutique, Sclérose latérale amyotrophique (mortalité), Sclérose latérale amyotrophique (traitement médicamenteux), Sujet âgé, Sujet âgé de 80 ans ou plus, Électrocardiographie.
- MESH :
- immunologie : Protéines Nogo.
- mortalité : Sclérose latérale amyotrophique.
- traitement médicamenteux : Sclérose latérale amyotrophique.
- usage thérapeutique : Anticorps monoclonaux humanisés, Facteurs immunologiques.
- Adolescent, Adulte, Adulte d'âge moyen, Analyse de survie, Coopération internationale, Facteurs de l'âge, Femelle, Humains, Jeune adulte, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Électrocardiographie.
English descriptors
- KwdEn :
- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Amyotrophic Lateral Sclerosis (drug therapy), Amyotrophic Lateral Sclerosis (mortality), Antibodies, Monoclonal, Humanized (therapeutic use), Double-Blind Method, Electrocardiography, Female, Humans, Immunologic Factors (therapeutic use), International Cooperation, Male, Middle Aged, Nogo Proteins (immunology), Survival Analysis, Treatment Outcome, Young Adult.
- MESH :
- chemical , immunology : Nogo Proteins.
- chemical , therapeutic use : Antibodies, Monoclonal, Humanized, Immunologic Factors.
- drug therapy : Amyotrophic Lateral Sclerosis.
- mortality : Amyotrophic Lateral Sclerosis.
- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Double-Blind Method, Electrocardiography, Female, Humans, International Cooperation, Male, Middle Aged, Survival Analysis, Treatment Outcome, Young Adult.
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, Nouvelle-Galles du Sud, Piémont, Provence-Alpes-Côte d'Azur, Région capitale de Séoul, Sussex de l'Est, Utrecht (province), Île-de-France
- Birmingham, Brighton, Falmer, Hanovre, Nice, Paris, Sydney, Séoul, Turin, Ulm, Utrecht
- Université d'Ulm, Université de Birmingham, Université de Sydney, Université du Sussex
Links toward previous steps (curation, corpus...)
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Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial.</title>
<author><name sortKey="Meininger, Vincent" sort="Meininger, Vincent" uniqKey="Meininger V" first="Vincent" last="Meininger">Vincent Meininger</name>
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<author><name sortKey="Genge, Angela" sort="Genge, Angela" uniqKey="Genge A" first="Angela" last="Genge">Angela Genge</name>
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<author><name sortKey="Chio, Adriano" sort="Chio, Adriano" uniqKey="Chio A" first="Adriano" last="Chio">Adriano Chio</name>
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<author><name sortKey="Kim, Seung H" sort="Kim, Seung H" uniqKey="Kim S" first="Seung H" last="Kim">Seung H. Kim</name>
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<author><name sortKey="Leigh, P Nigel" sort="Leigh, P Nigel" uniqKey="Leigh P" first="P Nigel" last="Leigh">P Nigel Leigh</name>
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<region type="état">Nouvelle-Galles du Sud</region>
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<author><name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Neurology, University Hospital of Nice, Nice</wicri:regionArea>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Nice</settlement>
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</author>
<author><name sortKey="Morrison, Karen E" sort="Morrison, Karen E" uniqKey="Morrison K" first="Karen E" last="Morrison">Karen E. Morrison</name>
<affiliation wicri:level="4"><nlm:affiliation>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Institute of Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Medicine, University of Southampton, University Hospital Southampton, Southampton</wicri:regionArea>
<orgName type="university">Université de Birmingham</orgName>
<placeName><settlement type="city">Birmingham</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Midlands de l'Ouest</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Petri, Susanne" sort="Petri, Susanne" uniqKey="Petri S" first="Susanne" last="Petri">Susanne Petri</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Neurology, Hannover Medical School, Hannover, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, Hannover Medical School, Hannover</wicri:regionArea>
<placeName><region type="land" nuts="2">Basse-Saxe</region>
<settlement type="city">Hanovre</settlement>
</placeName>
</affiliation>
</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>
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</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><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Age Factors</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Amyotrophic Lateral Sclerosis (drug therapy)</term>
<term>Amyotrophic Lateral Sclerosis (mortality)</term>
<term>Antibodies, Monoclonal, Humanized (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Electrocardiography</term>
<term>Female</term>
<term>Humans</term>
<term>Immunologic Factors (therapeutic use)</term>
<term>International Cooperation</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Nogo Proteins (immunology)</term>
<term>Survival Analysis</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Analyse de survie</term>
<term>Anticorps monoclonaux humanisés (usage thérapeutique)</term>
<term>Coopération internationale</term>
<term>Facteurs de l'âge</term>
<term>Facteurs immunologiques (usage thérapeutique)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Protéines Nogo (immunologie)</term>
<term>Résultat thérapeutique</term>
<term>Sclérose latérale amyotrophique (mortalité)</term>
<term>Sclérose latérale amyotrophique (traitement médicamenteux)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Électrocardiographie</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Nogo Proteins</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term>
<term>Immunologic Factors</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Amyotrophic Lateral Sclerosis</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Protéines Nogo</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Amyotrophic Lateral Sclerosis</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Sclérose latérale amyotrophique</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Sclérose latérale amyotrophique</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Anticorps monoclonaux humanisés</term>
<term>Facteurs immunologiques</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Age Factors</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Double-Blind Method</term>
<term>Electrocardiography</term>
<term>Female</term>
<term>Humans</term>
<term>International Cooperation</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Survival Analysis</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Analyse de survie</term>
<term>Coopération internationale</term>
<term>Facteurs de l'âge</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Électrocardiographie</term>
</keywords>
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<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>
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<orgName><li>Université d'Ulm</li>
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<li>Université de Sydney</li>
<li>Université du Sussex</li>
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</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>
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<name sortKey="Desnuelle, Claude" sort="Desnuelle, Claude" uniqKey="Desnuelle C" first="Claude" last="Desnuelle">Claude Desnuelle</name>
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</noRegion>
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<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"><region name="Région capitale de Séoul"><name sortKey="Kim, Seung H" sort="Kim, Seung H" uniqKey="Kim S" first="Seung H" last="Kim">Seung H. Kim</name>
</region>
</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"><region name="Nouvelle-Galles du Sud"><name sortKey="Kiernan, Matthew C" sort="Kiernan, Matthew C" uniqKey="Kiernan M" first="Matthew C" last="Kiernan">Matthew C. Kiernan</name>
</region>
</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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