{"id":13664,"date":"2026-05-03T14:18:31","date_gmt":"2026-05-03T12:18:31","guid":{"rendered":"https:\/\/www.afaf.asso.fr\/?p=13664"},"modified":"2026-05-03T14:18:33","modified_gmt":"2026-05-03T12:18:33","slug":"actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone","status":"publish","type":"post","link":"https:\/\/www.afaf.asso.fr\/2026\/05\/03\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\/","title":{"rendered":"Actualit\u00e9s relatives au programme de d\u00e9veloppement clinique de l\u2019omaveloxolone"},"content":{"rendered":"\n

Vous trouverez ci-dessous les derni\u00e8res informations communiqu\u00e9es par le groupe Biogen.<\/em><\/p>\n\n\n\n

\u00c9tude de phase 3 BRAVE (p\u00e9diatrie) \u2013 Une \u00e9tape atteinte en mati\u00e8re d\u2019inclusion<\/mark><\/strong><\/p>\n\n\n\n

L\u2019\u00e9tude BRAVE a atteint 50% de son objectif d\u2019inclusion, avec 128 participants recrut\u00e9s \u00e0 ce jour. Pour rappel, l\u2019\u00e9tude pr\u00e9voit d\u2019inclure jusqu\u2019\u00e0 255 participants.<\/p>\n\n\n\n

L\u2019\u00e9tude inclut d\u00e9sormais des enfants \u00e2g\u00e9s de 2 \u00e0 moins de 7 ans, en plus de ceux \u00e2g\u00e9s de 7 \u00e0 15 ans. Cette \u00e9tape importante nous permet de tenter de r\u00e9pondre aux besoins non couverts d\u2019une population p\u00e9diatrique plus large, quels que soient l\u2019\u00e2ge et la capacit\u00e9 de marche des patients (ambulatoires et non ambulatoires).<\/p>\n\n\n\n

Pour rappel, l\u2019\u00e9tude BRAVE est un essai clinique international de phase 3 \u00e9valuant l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 de l\u2019omaveloxolone chez des enfants atteints d\u2019ataxie de Friedreich et \u00e2g\u00e9s de 2 \u00e0 15 ans. Le recrutement pour l\u2019\u00e9tude BRAVE a d\u00e9but\u00e9 au mois de mai 2025 et se poursuit actuellement dans plusieurs centres cliniques \u00e0 travers le monde.<\/p>\n\n\n\n

Les centres actuellement actifs en France sont les suivants :<\/p>\n\n\n\n

\u2022 Paris : AP-HP \u2013 H\u00f4pital Armand Trousseau<\/p>\n\n\n\n

\u2022 Montpellier : CHU de Montpellier \u2013 H\u00f4pital Gui de Chauliac<\/p>\n\n\n\n

Les informations les plus r\u00e9centes concernant l\u2019\u00e9tude de phase 3 BRAVE sont publi\u00e9es sur clinicaltrials.gov (NCT06953583). Les personnes int\u00e9ress\u00e9es par cette \u00e9tude sont invit\u00e9es \u00e0 en discuter avec leur professionnel de sant\u00e9.<\/p>\n\n\n\n

Pour rappel, l\u2019omaveloxolone n\u2019est \u00e0 ce jour pas autoris\u00e9 dans le traitement des patients \u00e2g\u00e9s de 2 \u00e0 15 ans. L\u2019omaveloxolone est indiqu\u00e9 dans le traitement de l\u2019ataxie de Friedreich chez les personnes \u00e2g\u00e9es de 16 ans et plus.<\/p>\n\n\n\n

<\/p>\n\n\n\n

Fin de l\u2019\u00e9tude d\u2019extension en ouvert (OLE) MOXIe<\/mark><\/strong><\/p>\n\n\n\n

Le dernier participant a d\u00e9sormais termin\u00e9 l\u2019\u00e9tude d\u2019extension en ouvert (OLE) MOXIe.<\/p>\n\n\n\n

L\u2019\u00e9tude MOXIe \u00e9tait un essai international multicentrique, randomis\u00e9, en double aveugle et contr\u00f4l\u00e9 par placebo, suivi d\u2019une phase d\u2019extension en ouvert. Elle visait \u00e0 mieux comprendre la s\u00e9curit\u00e9 de l\u2019omaveloxolone ainsi que son impact sur l\u2019effort physique, le mouvement, la coordination et la qualit\u00e9 de vie des personnes atteintes vivant avec l\u2019ataxie de Friedreich.<\/p>\n\n\n\n

L\u2019\u00e9tude MOXIe a jou\u00e9 un r\u00f4le cl\u00e9 dans les autorisations r\u00e9glementaires de l\u2019omaveloxolone pour le traitement de l\u2019ataxie de Friedreich chez les patients \u00e2g\u00e9s de 16 ans et plus. La phase d\u2019extension en ouvert a permis d\u2019\u00e9valuer la s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 du traitement sur une dur\u00e9e allant jusqu\u2019\u00e0 trois ans.<\/p>\n\n\n\n

La finalisation de cette \u00e9tude constitue une \u00e9tape importante rendue possible gr\u00e2ce \u00e0 l\u2019implication des participants, de leurs familles, des investigateurs, des \u00e9quipes des centres et de l\u2019ensemble de la communaut\u00e9 de l\u2019ataxie de Friedreich.<\/p>\n\n\n\n

Nous esp\u00e9rons partager prochainement les donn\u00e9es finales de l\u2019\u00e9tude MOXIe lors d\u2019un congr\u00e8s scientifique.<\/p>\n\n\n\n

<\/p>\n\n\n\n

Exploration d\u2019une forme de comprim\u00e9 pour suspension buvable comme mode d\u2019administration alternatif de l\u2019omaveloxolone<\/mark><\/strong><\/p>\n\n\n\n

Biogen a lanc\u00e9 r\u00e9cemment une \u00e9tude de phase 1 visant \u00e0 \u00e9valuer la bio\u00e9quivalence d\u2019une forme \u00ab comprim\u00e9 \u00bb d\u2019omaveloxolone, destin\u00e9e \u00e0 \u00eatre administr\u00e9e sous forme de suspension buvable, comparativement \u00e0 la g\u00e9lule orale actuellement disponible.<\/p>\n\n\n\n

\u00c0 ce jour, l\u2019omaveloxolone est administr\u00e9 par voie orale sous forme de g\u00e9lules, ou avec le contenu des g\u00e9lules saupoudr\u00e9 sur de la compote de pommes. L\u2019objectif principal de cette \u00e9tude est d\u2019\u00e9valuer si l\u2019omaveloxolone est absorb\u00e9 et m\u00e9tabolis\u00e9 de mani\u00e8re comparable chez des adultes en bonne sant\u00e9 lorsqu\u2019il est administr\u00e9 sous forme de suspension buvable par rapport aux g\u00e9lules.<\/p>\n\n\n\n

Biogen est conscient que certaines personnes peuvent rencontrer des difficult\u00e9s \u00e0 avaler des g\u00e9lules et souhaite explorer des options suppl\u00e9mentaires d\u2019administration de l\u2019omaveloxolone. Si cette \u00e9tude est concluante et que cette nouvelle formulation est approuv\u00e9e par les autorit\u00e9s r\u00e9glementaires, elle pourrait permettre une administration du traitement sous forme liquide. Les informations les plus r\u00e9centes concernant cette \u00e9tude sont et seront publi\u00e9es sur ClinicalTrials.gov (NCT07297199).<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Vous trouverez ci-dessous les derni\u00e8res informations communiqu\u00e9es par le groupe Biogen. \u00c9tude de phase 3 BRAVE (p\u00e9diatrie) \u2013 Une \u00e9tape atteinte en mati\u00e8re d\u2019inclusion L\u2019\u00e9tude BRAVE a atteint 50% de son objectif d\u2019inclusion, avec 128 participants recrut\u00e9s \u00e0 ce jour. Pour rappel, l\u2019\u00e9tude pr\u00e9voit d\u2019inclure jusqu\u2019\u00e0 255 participants. L\u2019\u00e9tude inclut d\u00e9sormais des enfants \u00e2g\u00e9s de […]<\/p>\n","protected":false},"author":8,"featured_media":13665,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"ocean_front_end_style_editor":"no","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"on","ocean_gallery_id":[],"footnotes":""},"categories":[43],"tags":[],"class_list":["post-13664","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-informations_recherche","entry","has-media","owp-thumbs-layout-horizontal","owp-btn-normal","owp-tabs-layout-section","has-no-thumbnails"],"yoast_head":"\nActualit\u00e9s relatives au programme de d\u00e9veloppement clinique de l\u2019omaveloxolone - Association Fran\u00e7aise Ataxie de Friedreich<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.afaf.asso.fr\/2026\/05\/03\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Actualit\u00e9s relatives au programme de d\u00e9veloppement clinique de l\u2019omaveloxolone - Association Fran\u00e7aise Ataxie de Friedreich\" \/>\n<meta property=\"og:description\" content=\"Vous trouverez ci-dessous les derni\u00e8res informations communiqu\u00e9es par le groupe Biogen. \u00c9tude de phase 3 BRAVE (p\u00e9diatrie) \u2013 Une \u00e9tape atteinte en mati\u00e8re d\u2019inclusion L\u2019\u00e9tude BRAVE a atteint 50% de son objectif d\u2019inclusion, avec 128 participants recrut\u00e9s \u00e0 ce jour. Pour rappel, l\u2019\u00e9tude pr\u00e9voit d\u2019inclure jusqu\u2019\u00e0 255 participants. L\u2019\u00e9tude inclut d\u00e9sormais des enfants \u00e2g\u00e9s de […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.afaf.asso.fr\/2026\/05\/03\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\/\" \/>\n<meta property=\"og:site_name\" content=\"Association Fran\u00e7aise Ataxie de Friedreich\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-03T12:18:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-03T12:18:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.afaf.asso.fr\/wp-content\/uploads\/2026\/05\/logo-Biogen-scaled.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"856\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Caroline Gaboriau\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Caroline Gaboriau\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/2026\\\/05\\\/03\\\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/2026\\\/05\\\/03\\\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\\\/\"},\"author\":{\"name\":\"Caroline Gaboriau\",\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/#\\\/schema\\\/person\\\/7366aa03c1779ab28140e42231ed7b28\"},\"headline\":\"Actualit\u00e9s relatives au programme de d\u00e9veloppement clinique de l\u2019omaveloxolone\",\"datePublished\":\"2026-05-03T12:18:31+00:00\",\"dateModified\":\"2026-05-03T12:18:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/2026\\\/05\\\/03\\\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\\\/\"},\"wordCount\":683,\"publisher\":{\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/2026\\\/05\\\/03\\\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.afaf.asso.fr\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/logo-Biogen-scaled.png\",\"articleSection\":[\"Informations sur la recherche\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.afaf.asso.fr\\\/2026\\\/05\\\/03\\\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\\\/\",\"url\":\"https:\\\/\\\/www.afaf.asso.fr\\\/2026\\\/05\\\/03\\\/actualites-relatives-au-programme-de-developpement-clinique-de-lomaveloxolone\\\/\",\"name\":\"Actualit\u00e9s relatives au programme de d\u00e9veloppement clinique de l\u2019omaveloxolone - 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