Клинические исследование Первичный прогрессирующий рассеянный склероз: Tolebrutinib, Плацебо

Спонсоры	Ведущий спонсор: Sanofi
Источник	Sanofi
Краткое содержание	Основная цель: Определить эффективность SAR442168 по сравнению с плацебо в замедлении прогрессирования инвалидности. при первично-прогрессирующем рассеянном склерозе (ППРС) Второстепенные цели: Оценка эффективности SAR442168 по сравнению с плацебо в отношении чувствительных точек, появляются проявления помощи резонансной томографии (МРТ), когнитивные функции, физические и качественные функции жизнь Для оценки безопасности и переносимости SAR442168 Для оценки популяционной фармакокинетики (PK) SAR442168 его с PPMS и связь с эффективностью и безопасностью Оценить фармакодинамика SAR442168

Подробное описание

Продолжительность исследования будет варьироваться в зависимости от участника этого управляемого событиями исследования с продолжительностью лечения. примерно от 24 до 48 месяцев. Участникам, завершившим период лечения, будет предложено зарегистрироваться в отдельном длительном срок исследования безопасности.

Общий статус

Рекрутинг

Дата начала

2020-08-13

Дата завершения

2024-08-01

Дата первичного завершения

2024-08-01

Фаза

Фаза 3

Тип исследования

Интервенционный

Первичный результат

Мера	Временное ограничение
6-месячная подтвержденная прогрессия инвалидности (CDP)	Примерно до 48 месяцев

Вторичный результат

Мера	Временное ограничение
3-month confirmed disability progression (CDP)	Up to approximately 48 months
3-месячная замена в тесте на 9 отверстий (9-HPT)	Примерно до 48 месяцев
3-месячный переход на 25-футовую ходьбу на время (T25-FW)	Примерно до 48 месяцев
Изменение гиперинтенсивных очагов T2 на МРТ	От исходного уровня до 48 примерно месяцев
Время до наступления подтвержденного улучшения инвалидности (CDI)	От исходного уровня до 48 примерно месяцев
Процентное изменение потери объема мозга (BVL)	От 6 месяцев до приблизительно 48 месяцев -
Изменение когнитивной функции по оценке теста модальностей символов и цифр (SDMT)	От исходного уровня до примерно 48 месяцев
Изменение когнитивной функции по оценке Калифорнийского теста на вербальное обучение II (CVLT-II)	От исходного уровня до примерно 48 месяцев
Изменение качества жизни при рассеянном склерозе	От исходного уровня до примерно 48 месяцев
Безопасность и переносимость	От скрининга до примерно 48 месяцев
Популяционная фармакокинетика	Месяцы 6, 9 и 12
Изменение легкой цепи нейрофиламента плазмы (NfL)	От исходного уровня до примерно 48 месяцев
Изменение субпопуляций фенотипа лимфоцитов	От исходного уровня до примерно 48 месяцев
Изменения уровня сывороточного иммуноглобулина	От исходного уровня до примерно 48 месяцев
Изменение сывороточного хитиназо-3-подобного белка 1 (Chi3L1)	От исходного уровня до примерно 48 месяцев -

Регистрация

990

Состояние	Первичный прогрессирующий рассеянный склероз
Вмешательство	Тип вмешательства: Drug Название вмешательства: Tolebrutinib Описание: Pharmaceutical form: Film-coated Tablet Route of administration: Oral Этикетка Arm Group: SAR442168 Другое имя: SAR442168 Тип вмешательства: Препарат, средство, медикамент Название вмешательства: Плацебо Описание: Лекарственная форма: Таблетки, покрытые пленочной оболочкой. Способ применения: Перорально. Этикетка Arm Group: Плацебо
Приемлемость	Критерии: Критерии включения : - от 18 до 55 лет включительно - Диагностика ППРС по критериям McDonald 2017 г. - Расширенная шкала статуса инвалидности (EDSS) от 2,0 до 6,5 баллов включительно на скрининг - Длительность заболевания от появления симптомов РС 5,0 ИЛИ Пол: Все Минимальный возраст: 18 лет Максимальный возраст: 55 лет Здоровые волонтеры: Нет

Состояние

Первичный прогрессирующий рассеянный склероз

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Tolebrutinib

Описание: Pharmaceutical form: Film-coated Tablet Route of administration: Oral

Этикетка Arm Group: SAR442168

Другое имя: SAR442168

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: Лекарственная форма: Таблетки, покрытые пленочной оболочкой. Способ применения: Перорально.

Этикетка Arm Group: Плацебо

Приемлемость

Критерии:

Критерии включения : - от 18 до 55 лет включительно - Диагностика ППРС по критериям McDonald 2017 г. - Расширенная шкала статуса инвалидности (EDSS) от 2,0 до 6,5 баллов включительно на скрининг - Длительность заболевания от появления симптомов РС 5,0 ИЛИ

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

55 лет

Здоровые волонтеры:

Нет

Общий Официальный

Фамилия	Роль	Присоединение
Clinical Sciences & Operations	Study Director	Sanofi

Общий контакт

Фамилия: Trial Transparency email recommended (Toll free number for US & Canada)

Телефон: 800-633-1610

Телефон доб.: option 6

Расположение

Объект:	Положение дел:
Investigational Site Number :8400070 \| Arcadia, California, 91006, United States	Recruiting
Investigational Site Number :8400101 \| La Jolla, California, 92037, United States	Recruiting
Investigational Site Number :8400045 \| Long Beach, California, 90806, United States	Recruiting
Investigational Site Number :8400135 \| Newport Beach, California, 92663, United States	Recruiting
Investigational Site Number :8400088 \| Torrance, California, 90502, United States	Recruiting
Investigational Site Number :8400012 \| Denver, Colorado, 80262, United States	Recruiting
Investigational Site Number :8400025 \| Fort Collins, Colorado, 80528, United States	Recruiting
Investigational Site Number :8400029 \| Boca Raton, Florida, 33487, United States	Recruiting
Investigational Site Number :8400004 \| Maitland, Florida, 32761, United States	Recruiting
Investigational Site Number :8400006 \| Tampa, Florida, 33612, United States	Recruiting
Investigational Site Number :8400103 \| Honolulu, Hawaii, 96817, United States	Recruiting
Investigational Site Number :8400011 \| Northbrook, Illinois, 60062, United States	Recruiting
Investigational Site Number :8400071 \| Springfield, Illinois, 62701, United States	Recruiting
Investigational Site Number :8400044 \| Overland Park, Kansas, 66212, United States	Recruiting
Investigational Site Number :8400106 \| Lexington, Kentucky, 40536, United States	Recruiting
Investigational Site Number :8400107 \| New Orleans, Louisiana, 70121, United States	Recruiting
Investigational Site Number :8400034 \| Lutherville-Timonium, Maryland, 21093, United States	Recruiting
Investigational Site Number :8400072 \| Boston, Massachusetts, 02111, United States	Recruiting
Investigational Site Number :8400143 \| Boston, Massachusetts, 02215, United States	Recruiting
Investigational Site Number :8400046 \| Detroit, Michigan, 48201, United States	Recruiting
Investigational Site Number :8400058 \| Farmington Hills, Michigan, 48334, United States	Recruiting
Investigational Site Number :8400033 \| Owosso, Michigan, 48867, United States	Recruiting
Investigational Site Number :8400111 \| Rochester, Minnesota, 55905, United States	Recruiting
Investigational Site Number :8400153 \| Kansas City, Missouri, 64111, United States	Recruiting
Investigational Site Number :8400093 \| Ozark, Missouri, 65721, United States	Recruiting
Investigational Site Number :8400129 \| Omaha, Nebraska, 68198, United States	Recruiting
Investigational Site Number :8400047 \| Hackensack, New Jersey, 07601, United States	Recruiting
Investigational Site Number :8400038 \| New York, New York, 10029-6501, United States	Recruiting
Investigational Site Number :8400042 \| Stony Brook, New York, 11794, United States	Recruiting
Investigational Site Number :8400098 \| Durham, North Carolina, 27710, United States	Recruiting
Investigational Site Number :8400005 \| Raleigh, North Carolina, 27607, United States	Recruiting
Investigational Site Number :8400116 \| Winston-Salem, North Carolina, 27157, United States	Recruiting
Investigational Site Number :8400125 \| Cleveland, Ohio, 44195, United States	Recruiting
Investigational Site Number :8400150 \| Columbus, Ohio, 43221, United States	Recruiting
Investigational Site Number :8400147 \| Columbus, Ohio, 43235, United States	Recruiting
Investigational Site Number :8400020 \| Portland, Oregon, 97225, United States	Recruiting
Investigational Site Number :8400016 \| Philadelphia, Pennsylvania, 19107, United States	Recruiting
Investigational Site Number :8400024 \| Greer, South Carolina, 29651-1817, United States	Recruiting
Investigational Site Number :8400035 \| Franklin, Tennessee, 37064, United States	Recruiting
Investigational Site Number :8400036 \| San Antonio, Texas, 78258, United States	Recruiting
Investigational Site Number :8400022 \| Milwaukee, Wisconsin, 53215, United States	Recruiting
Investigational Site Number :8400028 \| Milwaukee, Wisconsin, 53226, United States	Recruiting
Investigational Site Number :0320004 \| Caba, Buenos Aires, C1023AAB, Argentina	Recruiting
Investigational Site Number :0320003 \| Rosario, Santa Fe, 2000, Argentina	Recruiting
Investigational Site Number :0360005 \| Concord, New South Wales, 2139, Australia	Recruiting
Investigational Site Number :0360003 \| Hobart, Tasmania, 7001, Australia	Recruiting
Investigational Site Number :0400004 \| Linz, 4021, Austria	Recruiting
Investigational Site Number :0400002 \| Wien, 1090, Austria	Recruiting
Investigational Site Number :1120004 \| Vitebsk, 210009, Belarus	Recruiting
Investigational Site Number :1120005 \| Vitebsk, 210037, Belarus	Recruiting
Investigational Site Number :0560009 \| Bruxelles, 1070, Belgium	Recruiting
Investigational Site Number :0560007 \| Bruxelles, 1200, Belgium	Recruiting
Investigational Site Number :0560003 \| Edegem, B-2650, Belgium	Recruiting
Investigational Site Number :0560004 \| Gent, 9000, Belgium	Recruiting
Investigational Site Number :0560006 \| Leuven, 3000, Belgium	Recruiting
Investigational Site Number :0560008 \| Liège, 4000, Belgium	Recruiting
Investigational Site Number :0560002 \| Mons, 7000, Belgium	Recruiting
Investigational Site Number :0560001 \| Pelt, 3900, Belgium	Recruiting
Investigational Site Number :1000002 \| Pleven, 5800, Bulgaria	Recruiting
Investigational Site Number :1000004 \| Sofia, 1113, Bulgaria	Recruiting
Investigational Site Number :1000008 \| Sofia, 1407, Bulgaria	Recruiting
Investigational Site Number :1000001 \| Sofia, 1431, Bulgaria	Recruiting
Investigational Site Number :1000010 \| Sofia, 1797, Bulgaria	Recruiting
Investigational Site Number :1240002 \| Edmonton, Alberta, T6G 2C8, Canada	Recruiting
Investigational Site Number :1240003 \| Ottawa, Ontario, K1H 8L6, Canada	Recruiting
Investigational Site Number :1240013 \| Toronto, Ontario, M5B 1W8, Canada	Recruiting
Investigational Site Number :1240004 \| Montreal, Quebec, H2X 0A9, Canada	Recruiting
Investigational Site Number :1240015 \| Montreal, Quebec, H3A 2B4, Canada	Recruiting
Investigational Site Number :1240007 \| Sherbrooke, Quebec, J1H 5N4, Canada	Recruiting
Investigational Site Number :1240001 \| Quebec, G1J 1Z4, Canada	Recruiting
Investigational Site Number :1520002 \| Santiago, Reg Metropolitana De Santiago, 7650568, Chile	Recruiting
Investigational Site Number :1520001 \| Santiago, Reg Metropolitana De Santiago, 8380456, Chile	Recruiting
Investigational Site Number :1560012 \| Beijing, 100053, China	Recruiting
Investigational Site Number :1560021 \| Beijing, 100700, China	Recruiting
Investigational Site Number :1560003 \| Beijing, 100730, China	Recruiting
Investigational Site Number :1560009 \| Beijing, 100730, China	Recruiting
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Investigational Site Number :1560004 \| Changchun, 130021, China	Recruiting
Investigational Site Number :1560015 \| Changsha, 410008, China	Recruiting
Investigational Site Number :1560005 \| Chengdu, 610041, China	Recruiting
Investigational Site Number :1560035 \| Fuzhou, 350005, China	Recruiting
Investigational Site Number :1560002 \| Guangzhou, 510630, China	Recruiting
Investigational Site Number :1560027 \| Hohhot, 010050, China	Recruiting
Investigational Site Number :1560001 \| Shanghai, 200040, China	Recruiting
Investigational Site Number :1560008 \| Taiyuan, 030001, China	Recruiting
Investigational Site Number :1560020 \| Tianjin, 300052, China	Recruiting
Investigational Site Number :1560026 \| Wenzhou, 325000, China	Recruiting
Investigational Site Number :1700001 \| Bogota, Colombia	Recruiting
Investigational Site Number :1910001 \| Zagreb, 10000, Croatia	Recruiting
Investigational Site Number :1910002 \| Zagreb, 10000, Croatia	Recruiting
Investigational Site Number :2030002 \| Brno, 65691, Czechia	Recruiting
Investigational Site Number :2030004 \| Hradec Kralove, 50005, Czechia	Recruiting
Investigational Site Number :2030001 \| Jihlava, 58633, Czechia	Recruiting
Investigational Site Number :2030003 \| Teplice, 415 29, Czechia	Recruiting
Investigational Site Number :2080001 \| Esbjerg, 6700, Denmark	Recruiting
Investigational Site Number :2080005 \| Holstebro, 7500, Denmark	Recruiting
Investigational Site Number :2330001 \| Tallinn, 11315, Estonia	Recruiting
Investigational Site Number :2500011 \| Bron, 69500, France	Recruiting
Investigational Site Number :2500005 \| Clermont Ferrand, 63003, France	Recruiting
Investigational Site Number :2500009 \| Lille, 59037, France	Recruiting
Investigational Site Number :2500006 \| Montpellier, 34295, France	Recruiting
Investigational Site Number :2500008 \| Nancy, 54035, France	Recruiting
Investigational Site Number :2500017 \| Nimes, 30029, France	Recruiting
Investigational Site Number :2500014 \| Paris, 75013, France	Recruiting
Investigational Site Number :2500007 \| Paris, 75019, France	Recruiting
Investigational Site Number :2500004 \| Poissy, 78300, France	Recruiting
Investigational Site Number :2500003 \| Rennes, 35033, France	Recruiting
Investigational Site Number :2500001 \| Strasbourg, 67098, France	Recruiting
Investigational Site Number :2500012 \| Toulouse, 31059, France	Recruiting
Investigational Site Number :2760005 \| Bayreuth, 95445, Germany	Recruiting
Investigational Site Number :2760009 \| Berlin, 10117, Germany	Recruiting
Investigational Site Number :2760020 \| Bochum, 44791, Germany	Recruiting
Investigational Site Number :2760001 \| Dresden, 01307, Germany	Recruiting
Investigational Site Number :2760012 \| Essen, 45147, Germany	Recruiting
Investigational Site Number :2760002 \| Gießen, 35385, Germany	Recruiting
Investigational Site Number :2760010 \| Halle (Saale), 06120, Germany	Recruiting
Investigational Site Number :2760006 \| Hannover, 30625, Germany	Recruiting
Investigational Site Number :2760018 \| München, 81377, Germany	Recruiting
Investigational Site Number :2760008 \| Münster, 48149, Germany	Recruiting
Investigational Site Number :2760004 \| Rostock, 18055, Germany	Recruiting
Investigational Site Number :2760011 \| Ulm, 89081, Germany	Recruiting
Investigational Site Number :3000001 \| Athens, 115 28, Greece	Recruiting
Investigational Site Number :3000006 \| Athens, 11535, Greece	Recruiting
Investigational Site Number :3000002 \| Athens, 12462, Greece	Recruiting
Investigational Site Number :3000007 \| Athens, 15125, Greece	Recruiting
Investigational Site Number :3000004 \| Larissa, 41110, Greece	Recruiting
Investigational Site Number :3000003 \| Thessaloniki, 546 36, Greece	Recruiting
Investigational Site Number :3000009 \| Thessaloniki, 55236, Greece	Recruiting
Investigational Site Number :3480202 \| Budapest, 1145, Hungary	Recruiting
Investigational Site Number :3480205 \| Budapest, 1152, Hungary	Recruiting
Investigational Site Number :3480204 \| Kistarcsa, 2143, Hungary	Recruiting
Investigational Site Number :3480203 \| Tatabánya, 2800, Hungary	Recruiting
Investigational Site Number :3560007 \| Gurgaon, 122001, India	Recruiting
Investigational Site Number :3560003 \| Gurgaon, 122002, India	Recruiting
Investigational Site Number :3560004 \| Mangaluru, 575018, India	Recruiting
Investigational Site Number :3560005 \| New Delhi, 110029, India	Recruiting
Investigational Site Number :3560002 \| New Delhi, 110060, India	Recruiting
Investigational Site Number :3760002 \| Ashkelon, 78278, Israel	Recruiting
Investigational Site Number :3760008 \| Jerusalem, 91120, Israel	Recruiting
Investigational Site Number :3760001 \| Ramat Gan, 5265601, Israel	Recruiting
Investigational Site Number :3760004 \| Safed, 13100, Israel	Recruiting
Investigational Site Number :3800002 \| Pozzilli, Isernia, 86077, Italy	Recruiting
Investigational Site Number :3800007 \| Cagliari, 09126, Italy	Recruiting
Investigational Site Number :3800015 \| Catania, 95123, Italy	Recruiting
Investigational Site Number :3800016 \| Firenze, 50134, Italy	Recruiting
Investigational Site Number :3800001 \| Milano, 20132, Italy	Recruiting
Investigational Site Number :3800003 \| Napoli, 80131, Italy	Recruiting
Investigational Site Number :3800006 \| Napoli, 80131, Italy	Recruiting
Investigational Site Number :3800013 \| Roma, 00189, Italy	Recruiting
Investigational Site Number :3920016 \| Chiba-shi, Chiba, 260-8677, Japan	Recruiting
Investigational Site Number :3920008 \| Koriyama-shi, Fukushima, 963-8052, Japan	Recruiting
Investigational Site Number :3920022 \| Morioka-shi, Iwate, 020-8505, Japan	Recruiting
Investigational Site Number :3920011 \| Kyoto-shi, Kyoto, 616-8255, Japan	Recruiting
Investigational Site Number :3920005 \| Niigata-shi, Niigata, 951-8520, Japan	Recruiting
Investigational Site Number :3920004 \| Moriguchi-shi, Osaka, 570-8507, Japan	Recruiting
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Investigational Site Number :3920018 \| Kawagoe-shi, Saitama, 350-8550, Japan	Recruiting
Investigational Site Number :3920014 \| Bunkyo-ku, Tokyo, 113-8431, Japan	Recruiting
Investigational Site Number :3920003 \| Kodaira-shi, Tokyo, 187-8551, Japan	Recruiting
Investigational Site Number :3920010 \| Ota-ku, Tokyo, 146-0065, Japan	Recruiting
Investigational Site Number :3920017 \| Shinjuku-ku, Tokyo, 160-8582, Japan	Recruiting
Investigational Site Number :3920015 \| Toyama-shi, Toyama, 930-0194, Japan	Recruiting
Investigational Site Number :3920009 \| Ube-shi, Yamaguchi, 755-8505, Japan	Recruiting
Investigational Site Number :4280002 \| Riga, LV-1002, Latvia	Recruiting
Investigational Site Number :4280003 \| Riga, LV-1005, Latvia	Recruiting
Investigational Site Number :4840004 \| Guadalajara, Jalisco, 44670, Mexico	Recruiting
Investigational Site Number :4840001 \| Cdmx, México, 06700, Mexico	Recruiting
Investigational Site Number :4840005 \| Cdmx, México, 14050, Mexico	Recruiting
Investigational Site Number :5280003 \| Breda, 4818 CK, Netherlands	Recruiting
Investigational Site Number :5280006 \| Groningen, 9728 NZ, Netherlands	Recruiting
Investigational Site Number :5280002 \| Sittard-Geleen, 6162 BG, Netherlands	Recruiting
Investigational Site Number :5780003 \| Bergen, 5021, Norway	Recruiting
Investigational Site Number :5780005 \| Tromsø, 9038, Norway	Recruiting
Investigational Site Number :6160003 \| Bydgoszcz, Kujawsko-pomorskie, 85-796, Poland	Recruiting
Investigational Site Number :6160001 \| Lodz, Lódzkie, 90-549, Poland	Recruiting
Investigational Site Number :6160005 \| Warszawa, Mazowieckie, 01-211, Poland	Recruiting
Investigational Site Number :6160006 \| Warszawa, Mazowieckie, 01-684, Poland	Recruiting
Investigational Site Number :6160002 \| Katowice, Slaskie, 40-571, Poland	Recruiting
Investigational Site Number :6160007 \| Katowice, Slaskie, 40-684, Poland	Recruiting
Investigational Site Number :6160004 \| Katowice, Slaskie, 40-686, Poland	Recruiting
Investigational Site Number :6200001 \| Braga, 4710-243, Portugal	Recruiting
Investigational Site Number :6200016 \| Leiria, 2410-197, Portugal	Recruiting
Investigational Site Number :6200007 \| Lisboa, 1349-019, Portugal	Recruiting
Investigational Site Number :6200002 \| Matosinhos, 4464-513, Portugal	Recruiting
Investigational Site Number :6200010 \| Porto, 4099-001, Portugal	Recruiting
Investigational Site Number :6200004 \| Santa Maria da Feira, 4520-211, Portugal	Recruiting
Investigational Site Number :6420008 \| Bucuresti, 022328, Romania	Recruiting
Investigational Site Number :6420004 \| Campulung, 115100, Romania	Recruiting
Investigational Site Number :6420003 \| Constanta, 900123, Romania	Recruiting
Investigational Site Number :6420013 \| Oradea, 410154, Romania	Recruiting
Investigational Site Number :6420001 \| Targu Mures, 540136, Romania	Recruiting
Investigational Site Number :6420002 \| Timisoara, 300736, Romania	Recruiting
Investigational Site Number :6430018 \| Barnaul, 656024, Russian Federation	Recruiting
Investigational Site Number :6430022 \| Ekaterinburg, 620102, Russian Federation	Recruiting
Investigational Site Number :6430004 \| Kazan, 420021, Russian Federation	Recruiting
Investigational Site Number :6430019 \| Kirov, 610998, Russian Federation	Recruiting
Investigational Site Number :6430021 \| Krasnoyarsk, 660029, Russian Federation	Recruiting
Investigational Site Number :6430013 \| Moscow, 117997, Russian Federation	Recruiting
Investigational Site Number :6430005 \| Moscow, 129110, Russian Federation	Recruiting
Investigational Site Number :6430011 \| Moscow, 129128, Russian Federation	Recruiting
Investigational Site Number :6430014 \| Nizhny Novgorod, 603137, Russian Federation	Recruiting
Investigational Site Number :6430008 \| Pyatigorsk, 357538, Russian Federation	Recruiting
Investigational Site Number :6430015 \| Rostov-on-Don, 344022, Russian Federation	Recruiting
Investigational Site Number :6430001 \| Saint-Petersburg, 197110, Russian Federation	Recruiting
Investigational Site Number :6430017 \| Saint-Petersburg, 197376, Russian Federation	Recruiting
Investigational Site Number :6430009 \| Samara, 443095, Russian Federation	Recruiting
Investigational Site Number :6430020 \| Saransk, 430032, Russian Federation	Recruiting
Investigational Site Number :6430010 \| St-Petersburg, 197022, Russian Federation	Recruiting
Investigational Site Number :6430007 \| Tyumen, 625000, Russian Federation	Recruiting
Investigational Site Number :6430006 \| Ufa, 450005, Russian Federation	Recruiting
Investigational Site Number :6880001 \| Belgrade, 11000, Serbia	Recruiting
Investigational Site Number :6880002 \| Kragujevac, 34000, Serbia	Recruiting
Investigational Site Number :6880004 \| Nis, 18000, Serbia	Recruiting
Investigational Site Number :7240012 \| La Coruña, A Coruña [La Coruña], 15006, Spain	Recruiting
Investigational Site Number :7240015 \| Santiago de Compostela, A Coruña [La Coruña], 15706, Spain	Recruiting
Investigational Site Number :7240007 \| Sevilla, Andalucia, 41009, Spain	Recruiting
Investigational Site Number :7240010 \| Barcelona, Barcelona [Barcelona], 08035, Spain	Recruiting
Investigational Site Number :7240013 \| Bilbao, Bizkaia, 48013, Spain	Recruiting
Investigational Site Number :7240011 \| Salt, Girona [Gerona], 17190, Spain	Recruiting
Investigational Site Number :7240002 \| Majadahonda, Madrid, 28222, Spain	Recruiting
Investigational Site Number :7240001 \| Pozuelo De Alarcón, Madrid, 28223, Spain	Recruiting
Investigational Site Number :7240004 \| Córdoba, 14004, Spain	Recruiting
Investigational Site Number :7240003 \| Madrid, 28007, Spain	Recruiting
Investigational Site Number :7240005 \| Malaga, 29010, Spain	Recruiting
Investigational Site Number :7240006 \| Murcia, 30120, Spain	Recruiting
Investigational Site Number :7240014 \| Palma de Mallorca, 07120, Spain	Recruiting
Investigational Site Number :7240008 \| Valencia, 46026, Spain	Recruiting
Investigational Site Number :7520001 \| Göteborg, 413 45, Sweden	Recruiting
Investigational Site Number :7520005 \| Motala, 591 85, Sweden	Recruiting
Investigational Site Number :7560003 \| Aarau, 5001, Switzerland	Recruiting
Investigational Site Number :7560002 \| Bern, 3010, Switzerland	Recruiting
Investigational Site Number :7920009 \| Ankara, 06100, Turkey	Recruiting
Investigational Site Number :7920014 \| Ankara, 06500, Turkey	Recruiting
Investigational Site Number :7920005 \| Eskisehir, Turkey	Recruiting
Investigational Site Number :7920010 \| Hatay, Turkey	Recruiting
Investigational Site Number :7920016 \| Istanbul, 34093, Turkey	Recruiting
Investigational Site Number :7920002 \| Istanbul, 34303, Turkey	Recruiting
Investigational Site Number :7920007 \| Istanbul, 34785, Turkey	Recruiting
Investigational Site Number :7920006 \| Istanbul, 34896, Turkey	Recruiting
Investigational Site Number :7920003 \| Istanbul, Turkey	Recruiting
Investigational Site Number :7920015 \| Izmir, 35100, Turkey	Recruiting
Investigational Site Number :7920001 \| Izmit, 41380, Turkey	Recruiting
Investigational Site Number :7920011 \| Kuttahta, 43100, Turkey	Recruiting
Investigational Site Number :7920012 \| Mersin, 33070, Turkey	Recruiting
Investigational Site Number :7920013 \| Samsun, Turkey	Recruiting
Investigational Site Number :7920008 \| Trabzon, 61080, Turkey	Recruiting
Investigational Site Number :8040020 \| Chernivtsi, 58023, Ukraine	Recruiting
Investigational Site Number :8040022 \| Ivano-Frankivsk, 76018, Ukraine	Recruiting
Investigational Site Number :8040012 \| Ivano-Frankivsk, 76493, Ukraine	Recruiting
Investigational Site Number :8040017 \| Kharkiv, 61068, Ukraine	Recruiting
Investigational Site Number :8040025 \| Kharkiv, 61068, Ukraine	Recruiting
Investigational Site Number :8040014 \| Kharkiv, 61103, Ukraine	Recruiting
Investigational Site Number :8040023 \| Kharkiv, 61103, Ukraine	Recruiting
Investigational Site Number :8040013 \| Kyiv, 02091, Ukraine	Recruiting
Investigational Site Number :8040015 \| Kyiv, 03115, Ukraine	Recruiting
Investigational Site Number :8040011 \| Lutsk, 43005, Ukraine	Recruiting
Investigational Site Number :8040002 \| Lviv, 79010, Ukraine	Recruiting
Investigational Site Number :8040007 \| Lviv, 79013, Ukraine	Recruiting
Investigational Site Number :8040010 \| Odesa, 65025, Ukraine	Recruiting
Investigational Site Number :8040004 \| Vinnytsia, 21050, Ukraine	Recruiting
Investigational Site Number :8040024 \| Vinnytsya, 21001, Ukraine	Recruiting
Investigational Site Number :8040008 \| Zhytormyr, 10002, Ukraine	Recruiting
Investigational Site Number :8260006 \| London, London, City Of, EC1M 6BQ, United Kingdom	Recruiting
Investigational Site Number :8260005 \| London, London, City Of, SW17 0QT, United Kingdom	Recruiting
Investigational Site Number :8260010 \| Swansea, Neath Port Talbot, SA6 6NL, United Kingdom	Recruiting
Investigational Site Number :8260012 \| Nottingham, Nottinghamshire, NG7 2UH, United Kingdom	Recruiting
Investigational Site Number :8260013 \| Oxford, Oxfordshire, OX3 9DU, United Kingdom	Recruiting
Investigational Site Number :8260001 \| Cardiff, Vale Of Glamorgan, The, CF4 4XY, United Kingdom	Recruiting
Investigational Site Number :8260019 \| Salford, M6 8HD, United Kingdom	Recruiting

Расположение Страны	Argentina Australia Austria Belarus Belgium Bulgaria Canada Chile China Colombia Croatia Czechia Denmark Estonia France Germany Greece Hungary India Israel Italy Japan Latvia Mexico Netherlands Norway Poland Portugal Romania Russian Federation Serbia Spain Sweden Switzerland Turkey Ukraine United Kingdom United States
Дата проверки	2022-01-12
Ответственная сторона	Тип: Спонсор
Имеет расширенный доступ	Нет
Количество рук	2
Группа вооружений	Метка: SAR442168 Тип: Experimental Описание: Dose 1 of oral SAR442168 daily Метка: Плацебо Тип: Плацебо Компаратор Описание: Плацебо, чтобы соответствовать SAR442168 ежедневно
Акроним	PERSEUS
Информация о дизайне исследования	Распределение: Рандомизированный Модель вмешательства: Параллельное назначение Первичное назначение: Уход Маскировка: Тройной (участник, исследователь, оценщик результатов)

Первично-прогрессирующий рассеянный склероз (PPMS) Исследование ингибитора тирозинкиназы Брутона (BTK) толебрутиниба (SAR442168)