{"id":5479,"date":"2025-10-13T10:20:41","date_gmt":"2025-10-13T10:20:41","guid":{"rendered":"https:\/\/medical.biomarin.com\/en-us\/?page_id=5479"},"modified":"2026-01-07T19:48:58","modified_gmt":"2026-01-07T19:48:58","slug":"neuronal-ceroid-lipofuscinosis-type-2-cln2-clinical-program","status":"publish","type":"page","link":"https:\/\/medical.biomarin.com\/en-us\/neuronal-ceroid-lipofuscinosis-type-2-cln2\/neuronal-ceroid-lipofuscinosis-type-2-cln2-clinical-program\/","title":{"rendered":"Neuronal Ceroid Lipofuscinosis type 2 (CLN2) Clinical Program"},"content":{"rendered":"<div id=\"acf-block-68710d6459d61\" class=\"hero hero-no-overlay hero-large-first-para\">\n            <div class=\"hero-background-image hero-background-image-desktop\" style=\"background-image: url(https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/10\/Program-banner-DNA.png?v=1.20);\"><\/div>\n\t    <div class=\"hero-background-image hero-background-image-mobile\" style=\"background-image: url(https:\/\/medical.biomarin.com\/en-us\/wp-content\/uploads\/sites\/2\/2025\/10\/Program-banner-bones-Mobile.png?v=1.20);\"><\/div>\n    \t<div class=\"overlay\"><\/div>\n\t<div class=\"wrapper\">\n\t\t<div class=\"inner-wrapper\">\n\t\t\t<div class=\"hero-content\">\n\t\t\t    \t\t\t        <ul class=\"breadcrumb\">\n\t\t\t            \t\t\t                                                                        <li><a href=\"https:\/\/medical.biomarin.com\/en-us\/neuronal-ceroid-lipofuscinosis-type-2-cln2\/\">Neuronal Ceroid Lipofuscinosis type 2 (CLN2)<\/a><\/li>\n                            \t\t\t                                                                        <li>Neuronal Ceroid Lipofuscinosis type 2 (CLN2) Clinical Program<\/li>\n                            \t\t\t            \t\t\t        <\/ul>\n\t\t\t    \t\t\t\t\t\t\t\t\t\t\t\t    <h1>Clinical Program\n<\/h1>\n\t\t\t\t\t\t\t\t\t\t\t\t    <p>Learn about Neuronal Ceroid Lipofuscinosis type 2 (CLN2) clinical trials and research at BioMarin<\/p>\n\t\t\t\t\t\t\t\t\n                <p class=\"inline-buttons\">\n                                                        <\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n\n<div id=\"acf-block-68cc1503e2b9e\" class=\"vblock pipeline pipeline-listing-wrapper\">\n    <!-- Pipeline Filter Header\n    Integration notes:\n    - Toggle button-filter-active class to filter button when active\n    - Component here is generic filter header and is also used for resources (filters themselves differ)\n    -->\n    <div class=\"block filter-header\">\n        <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                <h1>Neuronal Ceroid Lipofuscinosis type 2 (CLN2) Pipeline<\/h1>\n                \n                                    <div class=\"filters\">\n                        <a class=\"button button-filter\" href=\"#\"><span>Search\/Filter<\/span><\/a>\n                        <div class=\"filters-content\">\n                            <div class=\"wrapper\">\n                                <div class=\"inner-wrapper\">\n                                    <form>\n                                        <fieldset>\n                                            <legend>Filter by phase:<\/legend>\n                                            <div class=\"filter-checkboxes\">\n                                                <div class=\"form-item check-item\">\n                                                    <input type=\"checkbox\" id=\"filter-phase-pre-ind\">\n                                                    <label for=\"filter-phase-pre-ind\">Pre-IND<\/label>\n                                                <\/div>\n                                                <div class=\"form-item check-item\">\n                                                    <input type=\"checkbox\" id=\"filter-phase-observational\">\n                                                    <label for=\"filter-phase-observational\">Observational<\/label>\n                                                <\/div>\n                                                <div class=\"form-item check-item\">\n                                                    <input type=\"checkbox\" id=\"filter-phase-1\">\n                                                    <label for=\"filter-phase-1\">Phase 1<\/label>\n                                                <\/div>\n                                                <div class=\"form-item check-item\">\n                                                    <input type=\"checkbox\" id=\"filter-phase-2\">\n                                                    <label for=\"filter-phase-2\">Phase 2<\/label>\n                                                <\/div>\n                                                <div class=\"form-item check-item\">\n                                                    <input type=\"checkbox\" id=\"filter-phase-3\">\n                                                    <label for=\"filter-phase-3\">Phase 3<\/label>\n                                                <\/div>\n                                                <div class=\"form-item check-item\">\n                                                    <input type=\"checkbox\" id=\"filter-phase-4\">\n                                                    <label for=\"filter-phase-4\">Phase 4<\/label>\n                                                <\/div>\n                                            <\/div>\n                                        <\/fieldset>\n    \n                                                                                \n                                            \n                                                                                    <fieldset>\n                                                <legend>Filter by status:<\/legend>\n                                                <div 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value=\"filter-rec-stat-enrolling-by-invitation\">\n                                                                <label for=\"filter-rec-stat-enrolling-by-invitation\">Enrolling by Invitation<\/label>\n                                                            <\/div>\n                                                                                                                                                                                                                                                                                                                                                <div class=\"form-item check-item\">\n                                                                <input type=\"checkbox\" id=\"filter-rec-stat-not-started\" value=\"filter-rec-stat-not-started\">\n                                                                <label for=\"filter-rec-stat-not-started\">Not started<\/label>\n                                                            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value=\"filter-rec-stat-completed\">\n                                                                <label for=\"filter-rec-stat-completed\">Completed<\/label>\n                                                            <\/div>\n                                                                                                                                                                                                                                                                                                                                                <div class=\"form-item check-item\">\n                                                                <input type=\"checkbox\" id=\"filter-rec-stat-withdrawn\" value=\"filter-rec-stat-withdrawn\">\n                                                                <label for=\"filter-rec-stat-withdrawn\">Withdrawn<\/label>\n                                                            <\/div>\n                                                                                                                                                                                                                                                                                                                                                <div class=\"form-item check-item\">\n                                                                <input type=\"checkbox\" id=\"filter-rec-stat-unknown-status\" value=\"filter-rec-stat-unknown-status\">\n                                                                <label for=\"filter-rec-stat-unknown-status\">Unknown status<\/label>\n                                                            <\/div>\n                                                                                                                                                            <\/div>\n                                            <\/fieldset>\n                                            \n                                        <div class=\"filter-footer\">\n                                            <div class=\"filter-footer-reset\">\n                                                <a class=\"button button-text\" href=\"#\">Reset all filters<\/a>\n                                            <\/div>\n                                            <div class=\"filter-footer-submit\">\n                                                <a class=\"button button-text\" href=\"#\">Cancel<\/a>\n                                                <input type=\"submit\" class=\"button\" value=\"Apply filters\">\n                                            <\/div>\n                                        <\/div>\n                                    <\/form>\n                                <\/div>\n                            <\/div>\n                        <\/div>\n                    <\/div>\n                            <\/div>\n        <\/div>\n    <\/div>\n\n    <!-- Research Pipeline block -->\n    <div class=\"block bg-band pipeline-listing-main\">\n        <div class=\"wrapper\">\n            <div class=\"inner-wrapper\">\n                                                                            \n                                        <div class=\"pipeline-listing pipeline-enzyme-therapies\">\n                        <h2 class=\"h3\">Enzyme Therapies<\/h2>\n\n                                                                                                                                        <h3 class=\"h5 trial-phase trial-phase\">Trial phase<\/h3>\n\n                            <div class=\"pipeline-group\" data-trial-phase-class=\"trial-phase\">\n                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                \n                                                                            <div class=\"pipeline-headers\">\n                                            <div class=\"pipeline-headers-summary\">\n                                                <div class=\"pipeline-product\">Product (Trial)<\/div>\n                                                <div class=\"pipeline-condition\">Condition<\/div>\n                                                <div class=\"pipeline-technology\">Technology<\/div>\n                                            <\/div>\n                                            <div class=\"pipeline-phases\">\n                                                <div class=\"pipeline-phase pipeline-phase-pre-ind\">Pre-IND<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-1\">Phase 1<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-2\">Phase 2<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-3\">Phase 3<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-4\">Phase 4<\/div>\n                                                <div class=\"pipeline-expand\"><\/div>\n                                            <\/div>\n                                        <\/div>\n                                    \n                                    \n                                    <article class=\"pipeline-trial observational filter-condition-cln2-disease filter-tech-enzyme filter-rec-stat-active-not-recruiting\">\n                                        <div class=\"pipeline-summary\">\n                                            <div class=\"pipeline-headers-summary\">\n                                                <div class=\"pipeline-product\">\n                                                    <h3 class=\"h5\">Cerliponase alfa<\/h3>\n                                                    <p>(190-501)<\/p>\n                                                    <p class=\"status\"><span class=\"label\">Trial Status<\/span> <span class=\"status\">Active, Not Recruiting<\/span><\/p>\n                                                <\/div>\n                                                                                                    <div class=\"pipeline-condition\">\n                                                        <h4 class=\"h5\">Condition<\/h4>\n                                                        <p>CLN2 Disease<\/p>\n                                                    <\/div>\n                                                                                                                                                    <div class=\"pipeline-technology\">\n                                                        <h4 class=\"h5\">Technology<\/h4>\n                                                        <ul>\n                                                            <li>Enzyme<\/li>\n                                                        <\/ul>\n                                                    <\/div>\n                                                                                                <div class=\"pipeline-details\">\n                                                                                                            <h4>Title<\/h4>\n                                                        <p>Cerliponase Alfa Observational Study in the US<\/p>\n                                                    \n                                                                                                            <h4>Study Description<\/h4>\n                                                        <p>This is a multicenter, observational study for patients with a confirmed diagnosis of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as TPP1 deficiency, who intend to be or are currently being treated with cerliponase alfa.<\/p>\n                                                    \n                                                                                                            <div class=\"detail-boxes\">\n                                                                                                                                                                                            <div class=\"box\">\n                                                                    <h4>Primary Outcome Measures*<\/h4>\n<ul>\n<li>To evaluate the long-term safety of cerliponase alfa in patients with neuronal ceroid lipofuscinosis type 2<\/li>\n<\/ul>\n                                                                <\/div>\n                                                                                                                                                                                            <div class=\"box\">\n                                                                    <h4>Select Inclusion Criteria*<\/h4>\n<ul>\n<li>Diagnosed with CLN2 disease<\/li>\n<li>Currently receiving or plan to begin treatment with cerliponase alfa<\/li>\n<li>Parent\/guardian provides informed written consent if required<\/li>\n<\/ul>\n                                                                <\/div>\n                                                                                                                                                                                            <div class=\"box\">\n                                                                    <h4>Secondary Outcome Measures*<\/h4>\n<ul>\n<li>Hypersensitivity<\/li>\n<li>Impact of severe adverse events on motor and language functions<\/li>\n<\/ul>\n                                                                <\/div>\n                                                                                                                                                                                            <div class=\"box\">\n                                                                    <h4>Select Exclusion Criteria*<\/h4>\n<ul>\n<li>Currently receiving treatment in another investigational device or drug study<\/li>\n<\/ul>\n                                                                <\/div>\n                                                                                                                    <\/div>\n                                                    \n                                                    <p>* Additional measures\/criteria may apply.<br>\nCLN2, late infantile neuronal ceroid lipofuscinosis type 2; TPP1, tripeptidyl peptidase 1<\/p>\n                                                                                                            <p><a class=\"button button-text button-external\" href=\"https:\/\/clinicaltrials.gov\/study\/NCT04476862\" target=\"_blank\">For reference and comprehensive trial information, visit ClinicalTrials.gov NCT04476862<\/a><\/p>\n                                                                                                    <\/div>\n                                            <\/div>\n                                            <div class=\"pipeline-phases pipeline-inline-phases\">\n                                                <div class=\"pipeline-phase pipeline-phase-pre-ind\">Pre-IND<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-1\">Phase 1<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-2\">Phase 2<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-3\">Phase 3<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-4\">Phase 4<\/div>\n                                                <div class=\"pipeline-expand\"><\/div>\n                                            <\/div>\n                                            <div class=\"pipeline-phases\">\n                                                <div class=\"pipeline-phase pipeline-phase-pre-ind\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-1\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-2\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-3\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-4\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-expand\">\n                                                    <div class=\"trigger\"><\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/article>\n                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                \n                                    \n                                    \n                                    <article class=\"pipeline-trial observational filter-condition-cln2-disease filter-tech-enzyme filter-rec-stat-recruiting\">\n                                        <div class=\"pipeline-summary\">\n                                            <div class=\"pipeline-headers-summary\">\n                                                <div class=\"pipeline-product\">\n                                                    <h3 class=\"h5\">Cerliponase alfa<\/h3>\n                                                    <p>(190-504)<\/p>\n                                                    <p class=\"status\"><span class=\"label\">Trial Status<\/span> <span class=\"status\">Recruiting<\/span><\/p>\n                                                <\/div>\n                                                                                                    <div class=\"pipeline-condition\">\n                                                        <h4 class=\"h5\">Condition<\/h4>\n                                                        <p>CLN2 Disease<\/p>\n                                                    <\/div>\n                                                                                                                                                    <div class=\"pipeline-technology\">\n                                                        <h4 class=\"h5\">Technology<\/h4>\n                                                        <ul>\n                                                            <li>Enzyme<\/li>\n                                                        <\/ul>\n                                                    <\/div>\n                                                                                                <div class=\"pipeline-details\">\n                                                                                                            <h4>Title<\/h4>\n                                                        <p>Cerliponase Alfa Observational Study<\/p>\n                                                    \n                                                                                                            <h4>Study Description<\/h4>\n                                                        <p>To evaluate long-term safety of cerliponase alfa in patients with neuronal ceroid lipofuscinosis Type 2 (CLN2 disease).<\/p>\n                                                    \n                                                    \n                                                    <p>* Additional measures\/criteria may apply.<br>\nCLN2, late infantile neuronal ceroid lipofuscinosis type 2;<\/p>\n                                                                                                            <p><a class=\"button button-text button-external\" href=\"https:\/\/catalogues.ema.europa.eu\/node\/1605\/administrative-details\" target=\"_blank\">For reference and comprehensive trial information, visit EMA.Europa.eu EUPAS29031<\/a><\/p>\n                                                                                                    <\/div>\n                                            <\/div>\n                                            <div class=\"pipeline-phases pipeline-inline-phases\">\n                                                <div class=\"pipeline-phase pipeline-phase-pre-ind\">Pre-IND<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-1\">Phase 1<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-2\">Phase 2<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-3\">Phase 3<\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-4\">Phase 4<\/div>\n                                                <div class=\"pipeline-expand\"><\/div>\n                                            <\/div>\n                                            <div class=\"pipeline-phases\">\n                                                <div class=\"pipeline-phase pipeline-phase-pre-ind\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-1\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-2\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-3\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-phase pipeline-phase-4\">\n                                                    <div class=\"phase-progress phase-progress-0\"><div class=\"phase-progress-inner\"><\/div><\/div>\n                                                <\/div>\n                                                <div class=\"pipeline-expand\">\n                                                    <div class=\"trigger\"><\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/article>\n                                                            <\/div>\n                                            <\/div>\n                            <\/div>\n        <\/div>\n    <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":4712,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-5479","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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