Исследование по оценке высокой эффективности и безопасности в мире у участников с язвенным колитом от умеренной до высшей степени (LUCENT 3)
Название протокола
Клинические исследование Язвенный колит: мирикизумаб - 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
Это исследование предназначено для оценки долгосрочной эффективности и безопасности мирикизумаба у участников с активным язвенным колитом (ЯК) от умеренной до тяжелой степени.
Общий статус
Рекрутинг
Дата начала
2018-07-18
Дата завершения
2025-07-01
Дата первичного завершения
2023-08-23
Фаза
Фаза 3
Тип исследования
Интервенционный
Первичный результат
Мера
Временное ограничение
Процент участников в клинической ремиссии
Неделя 52
Вторичный результат
Мера
Временное ограничение
Percentage of Participants in Endoscopic Remission
Week 52
Процент участников в ремиссии без кортикостероидов
Неделя 52
Процент участников с гистологически-эндоскопической ремиссией слизистой на 52-й неделе
Неделя 52
Качество жизни, связанное со здоровьем: оценка опросника по воспалительным заболеваниям кишечника (IBDQ)
Исходный уровень до 52 недели
Симптомы язвенного колита: числовая оценка
Неделя 160
Процент участников, госпитализированных из-за язвенного колита
Исходный уровень до 160-й недели
Процент участников, перенесших операции при язвенном колите, включая колэктомию
Исходный уровень до 160-й недели
Регистрация
960
Состояние
Язвенный колит
Вмешательство
Тип вмешательства:
Препарат, средство, медикамент
Название вмешательства:
мирикизумаб
Описание:
Управляется СК.
Этикетка Arm Group:
мирикизумаб
Другое имя:
LY3074828
Приемлемость
Критерии:
- Критерии включения - Участники исследования AMAC (NCT02589665) или AMBG (NCT03524092), у которых в как минимум одно введение исследуемого препарата и не было досрочного прекращения исследования препарат, средство, медикамент. - Участники женского пола должны согласиться с требованиями контрацепции. - Критерий исключения - У участников не должно быть нового заболевания, включая рак в авторское исследование. - Участники не должны иметь каких-либо серьезных инфекций, включая, но не ограничиваясь к, гепатиту В, гепатиту С, ВИЧ/СПИДу и активному туберкулезу (ТБ) во время либо оригинальное исследование - Участники, возможно, не подвергались операции по поводу язвенного колита в исходном исследовании или вероятно, потребуется хирургическое вмешательство для лечения язвенного колита во время исследования. - У участников не должно быть аденоматозных полипов во время оригинации. исследования, которые не были удалены до начала этого исследования.
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:
Контакт:
Исследователь:
Digestive Health Specialists
| Dothan, Alabama, 36305, United States
Recruiting
334-836-3341
Paul B Lamb
Principal Investigator
Research Solutions of Arizona
| Litchfield Park, Arizona, 85340, United States
Recruiting
623-512-4340
Connie Hsu
Principal Investigator
Valleywise Health
| Phoenix, Arizona, 85008, United States
Recruiting
602-344-5194
Keng-Yu Chuang
Principal Investigator
inSite Digestive Health Care
| Arcadia, California, 91006, United States
Recruiting
626-359-3330
Elias A Tarakji
Principal Investigator
Care Access Research
| Berkeley, California, 94705, United States
Recruiting
510-234-5012
Mark Kogan
Principal Investigator
Om Research, LLC
| Lancaster, California, 93534, United States
Recruiting
661-388-2239
Jatinder S Pruthi
Principal Investigator
California Medical Research Group
| Northridge, California, 91324, United States
Recruiting
818-349-1979
Calin Arimie
Principal Investigator
Inland Empire Liver Foundation
| Rialto, California, 92377, United States
Recruiting
909-883-2999
Zeid Kayali
Principal Investigator
Clinical Applications Laboratories, Inc.
| San Diego, California, 92103, United States
Recruiting
619-260-1012
Vijayalakshmi S Pratha
Principal Investigator
Direct Helpers Medical Center
| Hialeah, Florida, 33012, United States
Recruiting
305-828-3555
Manuel Fernandez
Principal Investigator
Borland Groover Clinic
| Jacksonville, Florida, 32256 6004, United States
Recruiting
904-398-3262
Mark R Fleisher
Principal Investigator
Wellness Clinical Research
| Miami Lakes, Florida, 33016, United States
Recruiting
786-483-7856
Lucky Flores
Principal Investigator
Research Associates of South Florida, LLC
| Miami, Florida, 33156, United States
Recruiting
786-476-8790
Javier Sobrado
Principal Investigator
AdventHealth Orlando
| Orlando, Florida, 32803, United States
Recruiting
407-303-2570
Muhammad Hasan
Principal Investigator
Clintheory Healthcare
| Orlando, Florida, 32818, United States
Recruiting
407-698-3424
Souheil Moussly
Principal Investigator
Gastroenterology Associates of Pensacola, PA
| Pensacola, Florida, 32503, United States
Recruiting
850-436-4536
Frederic Newman
Principal Investigator
Florida Medical Clinic LLC
| Zephyrhills, Florida, 33542-7505, United States
Recruiting
813-780-8368
Mark Eisner
Principal Investigator
Digestive Healthcare of Georgia
| Atlanta, Georgia, 30309, United States
Recruiting
404-355-3200
Michael R Galambos
Principal Investigator
Grand Teton Research Group, PLLC
| Idaho Falls, Idaho, 83404, United States
Recruiting
208-528-4256
Clint E Behrend
Principal Investigator
NorthShore University HealthSystem
| Evanston, Illinois, 60201, United States
Recruiting
847-570-3708
Eugene F Yen
Principal Investigator
Indiana University School of Medicine
| Indianapolis, Indiana, 46202, United States
Recruiting
317-944-3332
Sashidhar V Sagi
Principal Investigator
Cotton-O'Neil Clinical Research Center, Digestive Health
| Topeka, Kansas, 66606, United States
Recruiting
785-270-4852
Curtis Baum
Principal Investigator
GI Alliance Research Baton Rouge
| Baton Rouge, Louisiana, 70809, United States
Recruiting
225-927-1190
Jonathon C Chapman
Principal Investigator
Delta Research Partners LLC
| Monroe, Louisiana, 71201, United States
Recruiting
318-283-2177
Bal Raj Bhandari
Principal Investigator
Nola Research Works, LLC
| New Orleans, Louisiana, 70125, United States
Recruiting
504-891-3613
Vivek Huilgol
Principal Investigator
University of Michigan
| Ann Arbor, Michigan, 48109, United States
Completed
Clinical Research Institute of Michigan, LLC
| Chesterfield, Michigan, 48047, United States
Recruiting
586-598-3329
Ronald P Fogel
Principal Investigator
Henry Ford Health System
| Novi, Michigan, 48377, United States
Recruiting
248-344-4147
Nirmal Kaur
Principal Investigator
Gastroenterology Associates of Western Michigan, P.L.C.
| Wyoming, Michigan, 49529, United States
Recruiting
616-328-5344
Allan G Coates
Principal Investigator
Minnesota Gastroenterology, P.A.
| Plymouth, Minnesota, 55446, United States
Recruiting
612-870-5599
Robert P McCabe
Principal Investigator
Lee Memorial Hospital
| Great Neck, New York, 11021, United States
Not yet recruiting
516-387-3990
Keith Sultan
Principal Investigator
Weill Cornell Medical College
| New York, New York, 10021, United States
Not yet recruiting
646-962-0985
Ellen J Scherl
Principal Investigator
Columbia University Medical Center
| New York, New York, 10032, United States
Recruiting
Le-Chu Su
Principal Investigator
University of North Carolina Center for Inflammatory Bowel Disease
| Chapel Hill, North Carolina, 27599, United States
Recruiting
919-843-3873
Animesh Jain
Principal Investigator
Carolina Digestive Diseases and Endoscopy Center
| Greenville, North Carolina, 27834, United States
Recruiting
252-752-8181
Phillip J Goldstein
Principal Investigator
Care Access - Youngstown
| Poland, Ohio, 44514, United States
Recruiting
330-707-1115
Sayed Yossef
Principal Investigator
Central Sooner Research
| Norman, Oklahoma, 73071, United States
Recruiting
405-329-0474
Robert A Gordon
Principal Investigator
University of Oklahoma Health Sciences Center
| Oklahoma City, Oklahoma, 73104, United States
Recruiting
405-271-2090
Richard F Harty
Principal Investigator
Care Access Research LLC
| Pottsville, Pennsylvania, 17901, United States
Recruiting
570-478-5120
Glenn Freed
Principal Investigator
Digestive Disease Associates, Ltd.
| Wyomissing, Pennsylvania, 19610, United States
Recruiting
Nirav Shah
Principal Investigator
Midwest Medical Care
| Sioux Falls, South Dakota, 57108, United States
Recruiting
605-310-2000
Chandar Singaram
Principal Investigator
Texas Digestive Disease Consultants
| Dallas, Texas, 75231, United States
Recruiting
817-424-1525
Timothy Ritter
Principal Investigator
Digestive Health Associates of Texas
| Garland, Texas, 75044, United States
Recruiting
972-265-8201
Harry Sarles
Principal Investigator
Biopharma Informatic, LLC
| Houston, Texas, 77084, United States
Recruiting
2819443610
James Arthur Maher
Principal Investigator
Gastroenterology Research of San Antonio
| San Antonio, Texas, 78229, United States
Recruiting
210-615-3848
Nicholas P Martinez
Principal Investigator
Southern Star Research Institute, LLC
| San Antonio, Texas, 78229, United States
Recruiting
210-581-2812
Jeff S Bullock
Principal Investigator
Texas Digestive Disease Consultants
| Southlake, Texas, 76092, United States
Recruiting
817-424-1525
Timothy Ritter
Principal Investigator
Care Access Research LLC - Salt Lake City
| Ogden, Utah, 84403, United States
Recruiting
908-941-2273
Chad Gonzales
Principal Investigator
Care Access Research LLC - Salt Lake City
| Salt Lake City, Utah, 84124, United States
Recruiting
801-893-1788
Peder J Pedersen
Principal Investigator
The Gastroenterology Group, P.C.
| Reston, Virginia, 20191, United States
Recruiting
703-766-2650
Emil Valle
Principal Investigator
Carilion Clinic
| Roanoke, Virginia, 24106, United States
Recruiting
540-224-5170
Maithili Chitnavis
Principal Investigator
Washington Gastroenterology, PLLC
| Tacoma, Washington, 98405, United States
Recruiting
253-272-1925
William Holderman
Principal Investigator
Mautalen Salud e Investigación
| Caba, Buenos Aires, C1128AAF, Argentina
Recruiting
541145143410
Emiliano Pablo Tron
Principal Investigator
CER Instituto Medico
| Quilmes, Buenos Aires, B1878DVC, Argentina
Recruiting
541143509600
Edgardo Gimenez
Principal Investigator
Fundación de Estudios Clínicos
| Rosario, Santa Fe, S2000DEJ, Argentina
Recruiting
543415290086
Martin Camilo Azum
Principal Investigator
Sanatorio 9 de Julio SA
| San Miguel de Tucuman, Tucuman, 4000, Argentina
Recruiting
543814504504
Abel Novillo
Principal Investigator
Centro de Investigaciones Médicas Tucuman
| SAN M. DE Tucuman, Tucumán, T4000AXL, Argentina
Recruiting
03514200180
Eduardo Ezequiel Ezequiel Martinez
Principal Investigator
Coastal Digestive Health
| Maroochydore, Queensland, 4558, Australia
Recruiting
61754080900
Hans Seltenreich
Principal Investigator
Mater University Hospital
| South Brisbane, Queensland, 4101, Australia
Recruiting
61731632371
Jakob Begun
Principal Investigator
Princess Alexandra Hospital
| Woolloongabba, Queensland, 4102, Australia
Recruiting
61731767792
Gerald Holtmann
Principal Investigator
Royal Adelaide Hospital
| Adelaide, South Australia, 5000, Australia
Recruiting
61870742200
Abdul Shaikh
Principal Investigator
Box Hill Hospital Outpatients
| Box Hill, Victoria, 3128, Australia
Recruiting
61390949548
Olga Niewiadomski
Principal Investigator
St. Vincent's Hospital
| Fitzroy, Victoria, 3065, Australia
Recruiting
61392313580
John Nik Sheng Ding
Principal Investigator
The Alfred Hospital
| Melbourne, Victoria, 3004, Australia
Recruiting
61390765739
Miles Sparrow
Principal Investigator
The Royal Melbourne Hospital
| Parkville, Victoria, 3050, Australia
Recruiting
61393427000
Finlay Macrae
Principal Investigator
AKH - Gastroenterologie und Hepatologie - Interne Medizin III
| Wien, Vienna, 1090, Austria
Recruiting
43014040047440
Walter Reinisch
Principal Investigator
Medizinische Universität Innsbruck
| Innsbruck, 6020, Austria
Recruiting
435125040
Robert Koch
Principal Investigator
Universitätsklinikum Salzburg
| Salzburg, 5020, Austria
Recruiting
435725525402
Sonja Gassner
Principal Investigator
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
| Tournai, Wallonne, Région, 7500, Belgium
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
| Hyderabad, Andhra Pradesh, 500058, India
Recruiting
91 9347364790
Mohammed Aejaz Habeeb
Principal Investigator
Apollo Research and Innovations, Apollo Hospitals International Ltd
| Gandhinagar, Gujarat, 382428, India
Recruiting
917966701843
Shravan Bohra
Principal Investigator
Shree Giriraj Hospital
| Rajkot, Gujarat, 360005, India
Recruiting
912812587087
Chetan Mehta
Principal Investigator
Nirmal Hospital Private Limited
| Surat, Gujarat, 395002, India
Recruiting
919408042224
Saumin Shah
Principal Investigator
M S Ramaiah Medical College and Hospitals
| Bangalore, Karnataka, 560054, India
Recruiting
9845156811
Avinash Balekuduru
Principal Investigator
Midas Multispeciality Hospital Pvt.Ltd.
| Nagpur, Maharashtra, 440010, India
Recruiting
91 7720033280
Shrikant Mukewar
Principal Investigator
Poona Medical Foundation. Ruby Hall Clinic
| Pune, Maharashtra, 411 001, India
Recruiting
+91-20-266455495
Nitin Pai
Principal Investigator
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
| Wardha, Maharashtra, 442004, India
Recruiting
(07152) - 287701
Vijendra Kirnake
Principal Investigator
Dayanand Medical College
| Ludhiana, Punjab, 141001, India
Recruiting
9111612481522
Ajit Sood
Principal Investigator
SR Kalla Memorial Gastro & General Hospital
| Jaipur, Rajasthan, 302001, India
Recruiting
91 9829050622
Mukesh Kalla
Principal Investigator
King George Medical University
| Lucknow, Uttar Pradesh, 226003, India
Not yet recruiting
09335920302
Abhijit Chandra
Principal Investigator
Fortis Hospital
| Noida, Uttar Pradesh, 201301, India
Recruiting
9810154088
Ajay Bhalla
Principal Investigator
Gandhi Hospital
| Telangana, 500003, India
Recruiting
04027505566
Shravan Shravan Porika
Principal Investigator
Beaumont Hospital
| Dublin, DUBLIN 9, Ireland
Recruiting
35318377755
Aoibhlinn O'Toole
Principal Investigator
Soroka Medical Center
| Beer Sheva, 8410101, Israel
Recruiting
972507413471
Arik Segal
Principal Investigator
Shaare Zedek Medical Center
| Jerusalem, 91031, Israel
Recruiting
97226666064
Eran Goldin
Principal Investigator
Galilee Medical Center Department of Internal Medicine A
| Nahariya, 22100, Israel
Recruiting
97249107748
Nimer Assy
Principal Investigator
Kaplan Medical Center
| Rehovot, 7610001, Israel
Recruiting
97289441587
Nachum Bruce Benjamin Mosenkis
Principal Investigator
Tel Aviv Sourasky Medical Center
| Tel Aviv, 6423906, Israel
Recruiting
97236973896
Sigal Fishman
Principal Investigator
Assaf Harofeh Medical Center
| Zerifin, 70300, Israel
Vilniaus Universiteto Ligonines Santariskiu Klinikos
| Vilnius, LT-08661, Lithuania
Recruiting
37068825454
Edita Kazenaite
Principal Investigator
Hospital Sultanah Bahiyah
| Alor Star, Kedah, 05460, Malaysia
Not yet recruiting
6047406227
Muhammad Radzi Bin Abu Hassan
Principal Investigator
Hospital Raja Perempuan Zainab II
| Kota Bahru, Kelantan, 15586, Malaysia
Not yet recruiting
60139395880
Norasiah Binti Abu Bakar
Principal Investigator
Pusat Perubatan University Kebangsaan Malaysia
| Cheras, Kuala Lumpur, 56000, Malaysia
Not yet recruiting
60124500026
Raja Affendi Bin Raja Ali
Principal Investigator
Hospital Universiti Sains Malaysia
| Kelantan, 16150, Malaysia
Recruiting
6097676595
Yeong Yeh Lee
Principal Investigator
University Malaya Medical Centre
| Kuala Lumpur, 59100, Malaysia
Not yet recruiting
6042225768
Choon Kin Lee
Principal Investigator
University Malaya Medical Centre
| Kuala Lumpur, 59100, Malaysia
Recruiting
60379492966
Ida Normiha Hilmi
Principal Investigator
Hospital Serdang
| Selangor, 43000, Malaysia
Recruiting
60196662174
Rosaida Hj Md Said
Principal Investigator
Centro Para el Desarrollo de la Medicina y de Asistencia Med
| Culiacan, Sinaloa, 80230, Mexico
Completed
Scientia Investigacion Clinica S.C.
| Chihuahua, 31203, Mexico
Recruiting
6146883416
Gaspar Iglesias Miramontes
Principal Investigator
Sociedad de Metabolismo y Corazon S.C.
| Veracruz, 91900, Mexico
Recruiting
522299323157
Aracely Cruz Palacios
Principal Investigator
Republican Clinical Hospital
| Chisinau, MD2025, Moldova, Republic of
Recruiting
1137379689636
Elina Berliba
Principal Investigator
ETZ Elisabeth Tilburg
| Tilburg, North Brabant, 5042AD, Netherlands
Recruiting
31132218466
Robert Laheij
Principal Investigator
Amsterdam UMC, locatie AMC
| Amsterdam, 1105 AZ, Netherlands
Recruiting
31205666545
Mark Lowenberg
Principal Investigator
Bernhoven Uden
| Uden, 5406 PT, Netherlands
Recruiting
31413401932
Ingrid Gisbertz
Principal Investigator
Universitair Medisch Centrum Utrecht
| Utrecht, 3584, Netherlands
Recruiting
31887574446
Herma Fidder
Principal Investigator
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Chorob Tkanki Lacznej
| Bydgoszcz, Kujawsko-pomorskie, 85-168, Poland
Recruiting
48523655106
Maria Klopocka
Principal Investigator
ZOZ Gastromed
| Lublin, Lubelskie, 20-582, Poland
Recruiting
48795404502
Wit Danilkiewicz
Principal Investigator
Promedica S.C
| Bedzin, 42-500, Poland
Recruiting
0048322971991
Lukasz Firkowski
Principal Investigator
Centrum Medyczne Pratia Bydgoszcz
| Bydgoszcz, 85-796, Poland
Recruiting
0048604937500
Marcin Sobon
Principal Investigator
Szpital Miejski Sw. Jana Pawla II
| Elblag, 82-300, Poland