Этразимод в сравнении с плацебо для лечения умеренно язвенного колита

Название протокола
Клинические исследование Язвенный колит: Etrasimod, Плацебо - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Arena Pharmaceuticals

Источник Arena Pharmaceuticals
Краткое содержание

независимый

Общий статус Рекрутинг
Дата начала 2021-04-19
Дата завершения 2023-05-01
Дата первичного завершения 2023-05-01
Фаза Фаза 2
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Доля участников, достигших клинической ремиссии, по оценке общей клинической оценки Мэйо Неделя 12
Вторичный результат
Мера Временное ограничение
Proportion of Participants With Reduction From Baseline in Both Endoscopic Score and Rectal Bleeding or in Both Endoscopic Score and Stool Frequency Week 12
Доля участников, достигших эндоскопического улучшения Неделя 12
Доля участников с гистологическим ответом по оценке индекса гистопатологии Робартса Неделя 12
Доля участников с клиническим ответом, оцененная по общему баллу Mayo Clinic Score Неделя 12
Доля участников с симптоматической ремиссией Неделя 12
Количество и тяжесть нежелательных явлений Примерно до 56 недель (52-недельный период лечения и 4-недельный период последующего наблюдения)
Регистрация 162
Состояние
  • Язвенный колит
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Etrasimod

Описание: Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment

Этикетка Arm Group: Etrasimod 2 mg

Другое имя: APD334

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: независимый

Этикетка Arm Group: Плацебо

Приемлемость

Критерии:

независимый

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

80 лет

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Arena CT.gov Administrator Study Director Arena Pharmaceuticals
Общий контакт

Фамилия: Arena CT.gov Administrator

Телефон: +1 855-218-9153

Расположение
Объект: Положение дел:
Gut P.C., dba Digestive Health Specialists | Dothan, Alabama, 36305, United States Recruiting
Arizona Digestive Health | Sun City, Arizona, 85351, United States Recruiting
Om Research LLC | Lancaster, California, 93534, United States Recruiting
Gastrointestinal Biosciences Clinical Trials, LLC | Los Angeles, California, 90067, United States Recruiting
United Medical Doctors | Murrieta, California, 92563, United States Recruiting
ACRC Studies | San Diego, California, 92119, United States Recruiting
Peak Gastroenterology Associates | Colorado Springs, Colorado, 80920, United States Recruiting
Gastro Florida | Clearwater, Florida, 33756, United States Recruiting
Gastro Florida | Clearwater, Florida, 33762, United States Recruiting
Florida Center for Gastroenterology | Largo, Florida, 33777, United States Recruiting
Research Associates of South Florida | Miami, Florida, 33156, United States Recruiting
Gastroenterology Group of Naples | Naples, Florida, 34102, United States Recruiting
NSB Research | New Smyrna Beach, Florida, 32168, United States Recruiting
Pediatric & Adult Research Center | Orlando, Florida, 32825, United States Recruiting
IMIC, Inc. | Palmetto Bay, Florida, 33157, United States Recruiting
Advanced Medical Research Center | Port Orange, Florida, 32127, United States Recruiting
GCP Clinical Research | Tampa, Florida, 33609, United States Recruiting
Guardian Angel Research Center | Tampa, Florida, 33614, United States Recruiting
Florida Medical Clinic, LLC | Zephyrhills, Florida, 33542, United States Recruiting
Illinois Gastroenterology Group-Gurnee | Gurnee, Illinois, 60031, United States Recruiting
Texas Digestive Disease Consultants d/b/a GI Alliance | Baton Rouge, Louisiana, 70809, United States Recruiting
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States Recruiting
UC Health Physicians Clifton | Cincinnati, Ohio, 45219, United States Recruiting
Great Lakes Medical Research, LLC | Mentor, Ohio, 44060, United States Recruiting
Susquehanna Research Group | Harrisburg, Pennsylvania, 17110, United States Recruiting
Rio Grande Gastroenterology | McAllen, Texas, 78503, United States Recruiting
Texas Digestive Disease Consultants, PLLC d/b/a GI Alliance | Southlake, Texas, 76092, United States Recruiting
Tyler Research Institute, LLC | Tyler, Texas, 75701, United States Recruiting
Gastro Health & Nutrition - Victoria | Victoria, Texas, 77904, United States Recruiting
Care Access | Ogden, Utah, 84403, United States Recruiting
Blue Ridge Medical Research | Lynchburg, Virginia, 24502, United States Recruiting
Washington Gastroenterology | Bellevue, Washington, 33603, United States Recruiting
Virginia Mason Medical Center | Seattle, Washington, 98101, United States Recruiting
Froedtert Memorial Lutheran Hospital | Milwaukee, Wisconsin, 53226, United States Recruiting
Coastal Digestive Health Pty Ltd. | Maroochydore, Queensland, 4558, Australia Recruiting
AZ Delta Roeselare Menen vzw | Roeselare, 8800, Belgium Recruiting
UMHAT "Kanev'' AD | Ruse, 7002, Bulgaria Recruiting
Diagnostic-Consultative Center I - Sliven, EOOD | Sliven, 8800, Bulgaria Recruiting
Acibadem City Clinic University Hospital EOOD | Sofia, 1407, Bulgaria Recruiting
DCC "Alexandrovska", EOOD | Sofia, 1431, Bulgaria Recruiting
UMHATEM "N.I. Pirogov', EAD | Sofia, 1606, Bulgaria Recruiting
Diagnostic Consultation Center CONVEX EOOD | Sofia, 1680, Bulgaria Recruiting
Medical Centre MEDICA Plus OOD | Veliko Tarnovo, 5000, Bulgaria Recruiting
University of Calgary, Heritage Medical Research Clinic | Calgary, Alberta, T2N 4Z6, Canada Recruiting
Hepato-Gastroenterologie HK s.r.o, t.r | Hradec, Kralov, 500 12, Czechia Recruiting
PreventaMed s.r.o. | Olomouc, 779 00, Czechia Recruiting
Fakultni nemocnice Ostrava | Ostrava - Poruba, 708 52, Czechia Recruiting
ISCARE a.s. | Praha 9, 190 00, Czechia Recruiting
Nemocnice Slany | Slany, 274 01, Czechia Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand-Hopital Estaing | Clermont-Ferrand Cedex 1, 63000, France Recruiting
Centre Hospitalier Universitaire de Genoble Alpes - CHU Michallon | Grenoble, 38043, France Recruiting
Centre Hospitalier Universitaire de Nantes - Hotel-Dieu | Nantes Cedex 1, 44093, France Recruiting
Centre Hospitalier Universitaire de Nice - Hopital de l'Archet2 | Nice Cedex 3, 6202, France Recruiting
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes, 35033, France Recruiting
Magen-Darm-Zentrum Remscheid | Remscheid, 42859, Germany Recruiting
Bugat Pal Korhaz | Gyongyos, Heves, 3200, Hungary Recruiting
Endoexpert Egészségügyi Szolgáltató Kft. | Budapest, 1054, Hungary Recruiting
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika | Budapest, 1088, Hungary Recruiting
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Gasztroenterologia | Debrecen, 4032, Hungary Recruiting
Edith Wolfson Medical Center | Holon, 5822012, Israel Recruiting
Shaare Zedek Medical Center | Jerusalem, 9103102, Israel Recruiting
Galilee Medical Center | Nahariya, 2210001, Israel Recruiting
Ospedale San Bortolo-UOC di Gastroenterologia Vicenza | Vicenza, 36100, Italy Recruiting
Yonsei University Wonju Severance Christian Hospital | Wonju, Gangwon-do, 25426, Korea, Republic of Recruiting
Yonsei University Wonju Severance Christian Hospital | Wonju, Gangwon-do, 26426, Korea, Republic of Recruiting
Kyungpook National University Chilgok Hospital | Daegu, Gyeongsangbuk-do, 41404, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 3722, Korea, Republic of Recruiting
Centrum Medyczne Oporow | Wroclaw, Dolnoslaskie, 52-416, Poland Recruiting
EuroMediCare Szpital Specjalistyczny z Przychodnia we Wroclawiu | Wroclaw, Dolnoslaskie, 54-144, Poland Recruiting
Amicare Sp. z o. o. | Lodz, Lodzkie, 90-644, Poland Recruiting
IP Clinic Sp z.o.o | Lodz, Lodzkie, 90-752, Poland Recruiting
Allmedica Badania Kliniczne Sp. z.o.o. Sp.k. | Nowy Targ, Malopolskie, 34-400, Poland Recruiting
Medicome Sp. z o. o | Oświęcim, Malopolskie, 32-600, Poland Recruiting
Centrum Zdrowia MDM | Warsaw, Mazowieckie, 00-635, Poland Recruiting
Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw, Mazowieckie, 02-507, Poland Recruiting
Centrum Medyczne Grunwald | Poznan, Weilkopolski, 60-369, Poland Recruiting
Solumed Centrum Medyczne | Poznan, Wielkopolskie, 60-529, Poland Recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin, Zachodnipomorskie, 71-434, Poland Recruiting
Centro Hospitalar Universitario de Sao Joao, E.P.E. | Porto, 4200-319, Portugal Recruiting
SBHI of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko | Nizhniy Novgorod, 603126, Russian Federation Recruiting
Clinicodiagnostic center "Ultramed" | Omsk, 644024, Russian Federation Recruiting
Medical Company "Hepatolog" LLC | Samara, 443045, Russian Federation Recruiting
Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical Advisory-Diagnostic Centre" | Stavropol, 355017, Russian Federation Recruiting
Hospital General Universitario de Alicante | Alicante, 28046, Spain Recruiting
Hospital Universitario La Paz | Madrid, 28046, Spain Recruiting
CNE Regional Clinical Hosptial of Ivano-Frankivsk Regional Council, Department of Gastroenterology | Ivano-Frankivsk, 76008, Ukraine Recruiting
CNE Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv City Council, Department of Proctology | Kharkiv, 61037, Ukraine Recruiting
Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council, Department of Gastroenterology | Kharkiv, 61124, Ukraine Recruiting
CNE Kyiv City Clinical Hospital #1 of Executive Body of Kyiv City Council (Kyiv City State Administration), Dep of Therapy #2 | Kyiv, 2091, Ukraine Recruiting
CNE Andrii Novak Transcarpathian Regional Clinical Hospital of Transcarpathian Reg Council, Department of Gastroenterology | Uzhgorod, 88018, Ukraine Recruiting
Medical Center of LLC Health Clinic, Med Clinical Investigational Center, Unit of Gastroenterology, Hepatology and Endocrinology | Vinnytsia, 21009, Ukraine Recruiting
Scientific and Research Institute of Invalid Rehabilitation of National Pirogov | Vinnytsia, 21029, Ukraine Recruiting
Расположение Страны

Australia

Belgium

Bulgaria

Canada

Czechia

France

Germany

Hungary

Israel

Italy

Korea, Republic of

Poland

Portugal

Russian Federation

Spain

Ukraine

United States

Дата проверки

2021-09-01

Ответственная сторона

Тип: Спонсор

Ключевые слова
  • Ulcerative colitis
  • Этрасимод
  • APD334
  • UC
Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Etrasimod 2 mg

Тип: Experimental

Метка: Плацебо

Тип: Компаратор плацебо

Акроним GLADIATOR UC
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Двойник (участник, исследователь)