Индукционное исследование мирикизумаба у участников с язвенным колитом средней и тяжелой степени (LUCENT 1)
Название протокола
Клинические исследование Язвенный колит: Mirikizumab, Плацебо - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры
Ведущий спонсор:
Eli Lilly and Company
Источник
Eli Lilly and Company
Краткое содержание
Целью данного исследования является оценка безопасности и эффективности мирикизумаба при участники с активным язвенным колитом (ЯК) от умеренной до тяжелой степени, перенесшие неадекватный ответ, потеря ответа или непереносимость традиционной или биологической терапии для УЦ.
Общий статус
Рекрутинг
Дата начала
2018-03-15
Дата завершения
2022-10-08
Дата первичного завершения
2021-01-21
Фаза
Фаза 3
Тип исследования
Интервенционный
Первичный результат
Мера
Временное ограничение
Процент участников с клинической ремиссией
Неделя 12
Вторичный результат
Мера
Временное ограничение
Percentage of Participants in Clinical Response
Week 12
Процент участников с эндоскопической ремиссией
Неделя 12
Процент участников с симптоматической ремиссией
Неделя 12
Процент участников симптоматического ответа
Неделя 12
Процент участников с гистологической ремиссией
Неделя 12
Процент участников эндоскопического ответа
Неделя 12
Изменение симптомов ЯК по сравнению с исходным уровнем на 12-й неделе: числовая шкала оценки (NRS)
Исходный уровень, неделя 12
Изменение качества жизни, связанного со здоровьем, по сравнению с 12-й неделей по сравнению с исходным уровнем: опросник по воспалительным заболеваниям кишечника (IBDQ)
Исходный уровень, неделя 12
Изменение фекального кальпротектина по сравнению с исходным уровнем на 12-й неделе
Исходный уровень, неделя 12
Фармакокинетика (ПК): клиренс Мирикизумаба
Недели 0, 4, 8 и 12: предварительная доза; Неделя 0 и 4: до 2 часов после введения дозы
Регистрация
1160
Состояние
Язвенный колит
Вмешательство
Тип вмешательства:
Drug
Название вмешательства:
Mirikizumab
Описание:
Administered IV
Этикетка Arm Group:
Mirikizumab
Другое имя:
LY3074828
Тип вмешательства:
Препарат, средство, медикамент
Название вмешательства:
Плацебо
Описание:
Администрируемый IV
Этикетка Arm Group:
Плацебо
Приемлемость
Критерии:
Критерии включения: - Диагноз язвенного колита не менее чем за 3 месяца до исходного уровня. - Подтвержденный диагноз умеренно или тяжело активного ЯК, по оценке модифицированного Оценка Мейо (MMS). - Демонстрировал неадекватную реакцию, потерю реакции или нетерпимость к традиционной или биологической терапии язвенного колита. - Если женщина, должны соответствовать требованиям контрацепции. Критерий исключения: - Участники с текущим диагнозом болезни Крона или воспаления кишечника заболевание неклассифицированное (неопределенный колит). - Участники с предыдущей колэктомией. - Участники с текущими признаками токсического мегаколона. - Предшествующее воздействие антител к IL12p40 (например, устекинумаб) или антител к IL-23p19 антитела (например, рисанкизумаб, бразикумаб, гуселкумаб или тилдракизумаб).
Пол:
Все
Минимальный возраст:
18 лет
Максимальный возраст:
80 лет
Здоровые волонтеры:
Нет
Общий Официальный
Фамилия
Роль
Присоединение
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Общий контакт
Фамилия:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Телефон:
1-317-615-4559
Расположение
Объект:
Положение дел:
Digestive Health Specialists of the Southeast
| Dothan, Alabama, 36305, United States
Active, not recruiting
Dcr-Pi, Pc
| Litchfield Park, Arizona, 85340, United States
Active, not recruiting
Maricopa Integrated Health System
| Phoenix, Arizona, 85008, United States
Active, not recruiting
Physicians Research Group
| Tempe, Arizona, 85284, United States
Completed
University of Arizona, CATS Research Center
| Tucson, Arizona, 85724, United States
Active, not recruiting
Yuma Gastro LLC
| Yuma, Arizona, 85364, United States
Completed
Valley Gastroenterology Cnslts
| Arcadia, California, 91006, United States
Active, not recruiting
Care Access Research
| Berkeley, California, 94705, United States
Active, not recruiting
Citrus Valley Health Partners
| Covina, California, 91722, United States
Completed
Valley View Internal Medicine
| Garden Grove, California, 92843, United States
Completed
University of California - San Diego
| La Jolla, California, 92093, United States
Active, not recruiting
Om Research, LLC
| Lancaster, California, 93534, United States
Active, not recruiting
Catalina Research Institute, LLC
| Montclair, California, 91763, United States
Completed
California Medical Research Group
| Northridge, California, 91324, United States
Active, not recruiting
Gastroenterology Associates
| Pasadena, California, 91105, United States
Completed
Clinical Applications Laboratories, Inc.
| San Diego, California, 92103, United States
Active, not recruiting
UCSF Medical Center at Mission Bay
| San Francisco, California, 94158, United States
Active, not recruiting
University of Colorado
| Aurora, Colorado, 80045, United States
Completed
Delta Waves Sleep Disorders and Research Center
| Colorado Springs, Colorado, 80918, United States
Completed
Gastro Florida
| Clearwater, Florida, 33756, United States
Completed
West Central Gastroenterology d/b/a Gastro Florida
| Clearwater, Florida, 33761, United States
Completed
Clinical Research of West Florida, Inc. (Clearwater)
| Clearwater, Florida, 33765, United States
Completed
Pioneer Clinical Research
| Coral Springs, Florida, 33067, United States
Completed
Doral Research Center
| Doral, Florida, 33166, United States
Active, not recruiting
Direct Helpers Medical Center
| Hialeah, Florida, 33012, United States
Active, not recruiting
Wellness Clinical Research
| Hialeah, Florida, 33012, United States
Active, not recruiting
The Center for Gastrointestinal Disorders
| Hollywood, Florida, 33021, United States
Completed
Nature Coast Clinical Research, LLC
| Inverness, Florida, 34452, United States
Active, not recruiting
SIH Research, LLC
| Kissimmee, Florida, 34741, United States
Active, not recruiting
Center for Advanced Gastroenterology, PLLC
| Maitland, Florida, 32751, United States
Active, not recruiting
Inpatient Research Clinic, LLC
| Miami Lakes, Florida, 33014, United States
Completed
Life Medical Center & Research, Inc
| Miami Lakes, Florida, 33014, United States
Active, not recruiting
Columbus Clinical Services, LLC
| Miami, Florida, 33125, United States
Completed
Research Associates of South Florida, LLC
| Miami, Florida, 33134, United States
Active, not recruiting
Coral Research Clinic Corp
| Miami, Florida, 33186, United States
Active, not recruiting
Pharma Research International, Inc.
| Naples, Florida, 34110, United States
Completed
Center for Interventional Endoscopy
| Orlando, Florida, 32804, United States
Active, not recruiting
Clintheory Healthcare
| Orlando, Florida, 32819, United States
Active, not recruiting
IMIC, Inc.
| Palmetto Bay, Florida, 33157, United States
Completed
Gastroenterology Associates of Pensacola, PA
| Pensacola, Florida, 32503, United States
Active, not recruiting
Florida Digestive Specialist
| Saint Petersburg, Florida, 33709, United States
Completed
Florida Medical Clinic LLC
| Zephyrhills, Florida, 33542-7505, United States
Active, not recruiting
Digestive Healthcare of Georgia
| Atlanta, Georgia, 30309, United States
Active, not recruiting
Gastrointestinal Diseases Research
| Columbus, Georgia, 31904, United States
Completed
Atlanta Gastroenterology Specialists, PC
| Suwanee, Georgia, 30024, United States
Completed
Grand Teton Research Group, PLLC
| Idaho Falls, Idaho, 83404, United States
Active, not recruiting
NorthShore University HealthSystem
| Evanston, Illinois, 60201, United States
Active, not recruiting
Lemah Creek Clinical Research
| Oakbrook Terrace, Illinois, 60181, United States
Active, not recruiting
Indiana University School of Medicine
| Indianapolis, Indiana, 46202, United States
Active, not recruiting
Iowa Digestive Disease Center
| Clive, Iowa, 50325, United States
Completed
University of Kansas Medical Center
| Kansas City, Kansas, 66160, United States
Active, not recruiting
WestGlen GI Consultants
| Shawnee Mission, Kansas, 66217, United States
Active, not recruiting
Cotton-O'Neil Clinical Research Center, Digestive Health
| Topeka, Kansas, 66606, United States
Active, not recruiting
Texas Digestive Disease Consultants
| Baton Rouge, Louisiana, 70809, United States
Active, not recruiting
Clinical Trials of SWLA, LLC
| Lake Charles, Louisiana, 70601, United States
Completed
Delta Research Partners LLC
| Monroe, Louisiana, 71201, United States
Active, not recruiting
Tulane Univ School of Med
| New Orleans, Louisiana, 70112 2715, United States
Completed
Nola Research Works, LLC
| New Orleans, Louisiana, 70125, United States
Active, not recruiting
University of Maryland Medical Center
| Baltimore, Maryland, 21201, United States
Active, not recruiting
University of Massachusetts Medical Center
| Worcester, Massachusetts, 01655, United States
Active, not recruiting
Clinical Research Institute of Michigan, LLC
| Chesterfield, Michigan, 48047, United States
Active, not recruiting
Henry Ford Health System
| Novi, Michigan, 48377, United States
Active, not recruiting
Gastroenterology Associates of Western Michigan, P.L.C.
| Wyoming, Michigan, 49519, United States
Active, not recruiting
Huron Gastroenterology Associates
| Ypsilanti, Michigan, 48197, United States
Active, not recruiting
Minnesota Gastroenterology, P.A.
| Plymouth, Minnesota, 55446, United States
Active, not recruiting
Washington University Medical School
| Saint Louis, Missouri, 63110, United States
Active, not recruiting
Bozeman Health Deaconess Hospital
| Bozeman, Montana, 59715, United States
Active, not recruiting
Capital Health Medical Center Hopewell
| Pennington, New Jersey, 08534, United States
Completed
Holy Name Medical Center
| Teaneck, New Jersey, 07666, United States
Active, not recruiting
Northwell Health
| Great Neck, New York, 11021, United States
Active, not recruiting
NYU Langone Long Island Clinical Research Associates
| Lake Success, New York, 11042, United States
Completed
Weill Cornell Medical College
| New York, New York, 10021, United States
Active, not recruiting
Mount Sinai - PRIME
| New York, New York, 10029, United States
Active, not recruiting
University of North Carolina
| Chapel Hill, North Carolina, 27599, United States
Active, not recruiting
Carolina Digestive Diseases
| Greenville, North Carolina, 27834, United States
Active, not recruiting
Wake Forest University School of Medicine
| Winston-Salem, North Carolina, 27157-1045, United States
Completed
Mid Dakota Clinic
| Bismarck, North Dakota, 58501, United States
Active, not recruiting
Trinity Health Center Medical Arts
| Minot, North Dakota, 58701, United States
Completed
META Medical Research Institute, LLC
| Dayton, Ohio, 45432, United States
Completed
Paramount Medical Research
| Middleburg Heights, Ohio, 44130, United States
Active, not recruiting
Care Access Research - Youngstown
| Poland, Ohio, 44514, United States
Active, not recruiting
Great Lakes Medical Research, LLC
| Westlake, Ohio, 44145, United States
Completed
Central Sooner Research
| Norman, Oklahoma, 73071, United States
Active, not recruiting
University of Oklahoma Health Sciences Center
| Oklahoma City, Oklahoma, 73104, United States
Active, not recruiting
Care Access Research LLC
| Pottsville, Pennsylvania, 17901, United States
Active, not recruiting
Digestive Disease Associates, Ltd.
| Wyomissing, Pennsylvania, 19610, United States
Active, not recruiting
Ocean State Clinical Research Partners
| Lincoln, Rhode Island, 02865, United States
Completed
Invocare Clinical Research Center
| Mauldin, South Carolina, 29662, United States
Active, not recruiting
Invocare Clinical Research Center
| West Columbia, South Carolina, 29169, United States
Completed
Midwest Medical Care
| Sioux Falls, South Dakota, 57108, United States
Active, not recruiting
Gastro One
| Germantown, Tennessee, 38138, United States
Active, not recruiting
Galen Medical Group
| Hixson, Tennessee, 37343, United States
Active, not recruiting
Vanderbilt University Medical Center
| Nashville, Tennessee, 37232, United States
Completed
Doctors Hospital at Renaissance Research Institute
| Edinburg, Texas, 78539, United States
Active, not recruiting
University of Texas Medical Branch at Galveston
| Galveston, Texas, 77555, United States
Completed
Digestive Health Associates of Texas
| Garland, Texas, 75044, United States
Active, not recruiting
Houston Methodist Research Ins
| Houston, Texas, 77030, United States
Active, not recruiting
Biopharma Informatic, Inc.
| Houston, Texas, 77084, United States
Active, not recruiting
Gastroenterology Research of San Antonio
| San Antonio, Texas, 78229, United States
Active, not recruiting
Southern Star Research Institute, LLC
| San Antonio, Texas, 78229, United States
Active, not recruiting
BFHC Research
| San Antonio, Texas, 78249, United States
Completed
Texas Digestive Disease Consultants
| Southlake, Texas, 76092, United States
Active, not recruiting
GI and Liver Research, LLC
| Webster, Texas, 77598, United States
Completed
Care Access Research LLC - Salt Lake City
| Ogden, Utah, 84403, United States
Active, not recruiting
Care Access Research LLC - Salt Lake City
| Salt Lake City, Utah, 84124, United States
Completed
Emeritas Research Group
| Leesburg, Virginia, 20176, United States
Active, not recruiting
Blue Ridge Medical Research
| Lynchburg, Virginia, 24502, United States
Completed
Gastroenterology Associates, PC
| Manassas, Virginia, 20110, United States
Active, not recruiting
The Gastroenterology Group, P.C.
| Reston, Virginia, 20191, United States
Completed
Carilion Clinic
| Roanoke, Virginia, 24016, United States
Active, not recruiting
University of Washington Medical Center
| Seattle, Washington, 98195-6424, United States
Completed
Digestive Health Specialists
| Tacoma, Washington, 98405, United States
Active, not recruiting
Wisconsin Center for Advanced Research
| Milwaukee, Wisconsin, 53215, United States
Active, not recruiting
Allegiance Research Specialists, LLC
| Milwaukee, Wisconsin, 53226, United States
Completed
Centro de Investigaciones Metabólicas (CINME)
| Caba, Buenos Aires, C1027AAP, Argentina
Active, not recruiting
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
| Ciudad Autonoma De Buenos Air, Buenos Aires, C1128AAF, Argentina
Active, not recruiting
CER Instituto Medico
| Quilmes, Buenos Aires, B1878DVC, Argentina
Active, not recruiting
Instituto de Investigaciones Clinicas Quilmes
| Quilmes, Buenos Aires, B1878GEG, Argentina
Completed
Fundación de Estudios Clínicos
| Rosario, Santa Fe, S2000DEJ, Argentina
Active, not recruiting
Sanatorio 9 de Julio SA
| San Miguel de Tucuman, Tucuman, 4000, Argentina
Active, not recruiting
Centro Medico Privado de Reumatologia
| SAN M. DE Tucuman, Tucumán, T4000AXL, Argentina
Active, not recruiting
Hospital Privado Centro Medico de Cordoba SA
| Cordoba, X5016KEH, Argentina
Active, not recruiting
John Hunter Hospital
| Newcastle, New South Wales, 2305, Australia
Completed
Princess Alexandra Hospital
| Brisbane, Queensland, 4102, Australia
Active, not recruiting
Coastal Digestive Health
| Maroochydore, Queensland, 4558, Australia
Active, not recruiting
Mater University Hospital
| South Brisbane, Queensland, 4101, Australia
Completed
Royal Adelaide Hospital
| Adelaide, South Australia, 5000, Australia
Active, not recruiting
Box Hill Hospital
| Box Hill, Victoria, 3128, Australia
Active, not recruiting
The Northern Hospital
| Epping, Victoria, 3076, Australia
Completed
Melbourne Gastrointestinal Investigation Unit (MGIU)
| Malvern, Victoria, 3144, Australia
Completed
The Alfred Hospital
| Melbourne, Victoria, 3004, Australia
Active, not recruiting
The Royal Melbourne Hospital
| Parkville, Victoria, 3050, Australia
Active, not recruiting
Medizinische Universität Innsbruck
| Innsbruck, 6020, Austria
Active, not recruiting
Universitätsklinikum Salzburg
| Salzburg, 5020, Austria
Active, not recruiting
Medical University of Vienna
| Vienna, 1090, Austria
Active, not recruiting
Krankenhaus der Barmherzigen Schwestern
| Wien, 1060, Austria
Osmania Medical College & Hospital
| Hyderabad, Andhra Pradesh, 500012, India
Active, not recruiting
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
| Hyderabad, Andhra Pradesh, 500058, India
Active, not recruiting
Yashoda Hospital
| Secunderabad, Andhra Pradesh, 500003, India
Active, not recruiting
Institute of Digestive and Liver Diseases
| Guwahati, Assam, 781 006, India
Completed
Escorts Heart Institute and Research Centre Ltd
| New Delhi, Delhi, 110 025, India
Active, not recruiting
Sir Ganga Ram Hospital
| New Delhi, Delhi, 110060, India
Completed
Apollo Research and Innovations, Apollo Hospitals International Ltd
| Gandhinagar, Gujarat, 382428, India
Active, not recruiting
Shree Giriraj Hospital
| Rajkot, Gujarat, 360005, India
Active, not recruiting
Nirmal Hospital Private Limited
| Surat, Gujarat, 395002, India
Active, not recruiting
Bangalore Medical College and Research Institute
| Bangalore, Karnataka, 560 002, India
Active, not recruiting
M S Ramaiah Medical College Hospital
| Bangalore, Karnataka, 560054, India
Active, not recruiting
Lokmanya Hospital
| Mumbai, Maharashtra, 400022, India
Completed
Fortis Hospital
| Mumbai, Maharashtra, 400078, India
Active, not recruiting
Poona Medical Foundation. Ruby Hall Clinic
| Pune, Maharashtra, 411 001, India
Active, not recruiting
K E M Hospital and Research Centre
| Pune, Maharashtra, 411011, India
Completed
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
| Wardha, Maharashtra, 442004, India
Active, not recruiting
Midas Multispecilaity Hopsital Pvt Ltd
| Ramdaspeth, Nagpur, 440010, India
Active, not recruiting
Dayanand Medical College
| Ludhiana, Punjab, 141001, India
Active, not recruiting
S.R. Kalla Hospital
| Jaipur, Rajasthan, 302001, India
Active, not recruiting
King George Medical University
| Lucknow, Uttar Pradesh, 226003, India
Active, not recruiting
Fortis Hospital
| Noida, Uttar Pradesh, 201301, India
Active, not recruiting
SSKM Post Graduate Hospital
| Kolkata, West Bengal, 700020, India
Completed
Nil Ratan Sircar Medical College
| Kolkata, West Bengal, 700073, India
Completed
Asian Institute of Gastroenterology
| Hyderabad, 500082, India
Completed
Gandhi Hospital
| Telangana, 500003, India
Active, not recruiting
Beaumont Hospital
| Dublin, DUBLIN 9, Ireland
Active, not recruiting
Shaare Zedek Medical Center
| Bait Vagan, Jerusalem, 91031, Israel
Active, not recruiting
Soroka Medical Center - Pediatric Outpatient Clinic
| Beer-Sheva, 8410101, Israel
Active, not recruiting
Meir Medical Center
| Kfar Saba, 4428164, Israel
Completed
Galilee Medical Center Department of Internal Medicine A
| Nahariya, 2210001, Israel
Active, not recruiting
Chaim Sheba Medical Center
| Ramat Gan, 5262100, Israel
Completed
Kaplan Medical Center
| Rehovot, 7610001, Israel
Active, not recruiting
Tel Aviv Sourasky Medical Center
| Tel Aviv, 6423906, Israel
Active, not recruiting
Assaf Harofeh Medical Center
| Zerifin, 70300, Israel
Clinical Trials Center of Medical Institute
| Kaliningrad, 236035, Russian Federation
Active, not recruiting
State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan"
| Kazan, 420064, Russian Federation