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Beata Dupejova, neurologická ambulancia S.R.O.","Banská Bystrica","97404","Slovakia","SK",{"type":99,"coordinates":605},[606,607],19.14932,48.73947,{"lat":607,"lon":606},{"facility":610,"status":88,"city":611,"state":612,"zip":613,"country":614,"countryCode":615,"cosmosGeoPoint":616,"geoPoint":620,"contacts":16},"Hospital Alvaro Cunqueiro","Vigo","Galicia","36312","Spain","ES",{"type":99,"coordinates":617},[618,619],-8.72264,42.23282,{"lat":619,"lon":618},{"facility":622,"status":88,"city":623,"state":623,"zip":624,"country":614,"countryCode":615,"cosmosGeoPoint":625,"geoPoint":629,"contacts":16},"Hospital Universitario 12 de Octubre","Madrid","28041",{"type":99,"coordinates":626},[627,628],-3.70256,40.4165,{"lat":628,"lon":627},{"facility":631,"status":88,"city":632,"state":623,"zip":633,"country":614,"countryCode":615,"cosmosGeoPoint":634,"geoPoint":638,"contacts":16},"Hospital Universitario Puerta de Hierro de Majadahonda","Majadahonda","28222",{"type":99,"coordinates":635},[636,637],-3.87182,40.47353,{"lat":637,"lon":636},{"facility":640,"status":88,"city":641,"state":642,"zip":643,"country":614,"countryCode":615,"cosmosGeoPoint":644,"geoPoint":648,"contacts":16},"Hospital Vithas Nisa Sevilla","Castilleja de la Cuesta","Seville","41950",{"type":99,"coordinates":645},[646,647],-6.05258,37.38594,{"lat":647,"lon":646},{"facility":650,"status":88,"city":651,"state":16,"zip":652,"country":614,"countryCode":615,"cosmosGeoPoint":653,"geoPoint":657,"contacts":16},"Complejo Hospitalario Universitario A Coruna","A Coruña","15006",{"type":99,"coordinates":654},[655,656],-8.396,43.37135,{"lat":656,"lon":655},{"facility":659,"status":88,"city":660,"state":16,"zip":661,"country":662,"countryCode":663,"cosmosGeoPoint":664,"geoPoint":668,"contacts":16},"Limited Liability Company \"Neurofocus\"","Lviv","79029","Ukraine","UA",{"type":99,"coordinates":665},[666,667],24.02324,49.83826,{"lat":667,"lon":666},{"type":670,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100598128","phase-3-a-study-of-orelabrutinib-in-patients-with-primary-progressive-multiple-sclerosis-100598128",false,"NCT07067463","A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis","A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong\u002Fmoderate CYP3A inhibitors or strong\u002Fmoderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","ALL","18 Years","60 Years",{"count":682,"type":683},705,"ESTIMATED","INTERVENTIONAL",[686],"PHASE3","Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.",[689],"Multiple Sclerosis (MS) Primary Progressive","2026-09-14",{"date":692,"type":693},"2026-09-15","ACTUAL",{"date":695,"type":693},"2026-03-23",{"date":697,"type":683},"2030-07",{"name":5,"class":6},63]