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Активно (без набиране) Фаза 3 NCT04232553

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Фаза 3 – широко изпитване преди одобрение
Заболявания: Crohn's Disease

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
Кой може да участва
Inclusion Criteria: * Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130) * If female, participant must meet the contraception requirements Exclusion Criteria: * Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial. * Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study. Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study. * Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy. * Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
Места на провеждане 30
Argentina (1)
DOM Centro de Reumatología
Buenos Aires
Австралия (1)
Concord Repatriation General Hospital
Concord , New South Wales
Белгия (1)
Imelda General Hospital
Bonheiden , Antwerpen
Бразилия (1)
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador , Estado de Bahia
Канада (1)
Gastroenterology and internal medicine research institute
Edmonton , Alberta
Китай (1)
Anhui Provincial Hospital
Hefei , Anhui
Хърватия (1)
Klinički bolnički centar Zagreb
Zagreb , City of Zagreb
Чехия (1)
Vojenská Nemocnice Brno
Brno , Brno-město
Дания (1)
Gastroenterologische Praxis Balsiger, Seibold & Partner
Aalborg , North Denmark
Франция (1)
Chu Saint Eloi
Montpellier , Languedoc-Roussillon
Унгария (1)
Synexus Magyarország Kft
Gyula , Bekes County
Индия (1)
Gujarat Hospital - Gastro & Vascular Centre
Surat , Gujarat
Израел (1)
Sheba Medical Center
Ramat Gan , Central District
Италия (1)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan , Lombardy
Япония (1)
National Hospital Organization Hirosaki General Medical Center
Hirosaki , Aomori
Latvia (1)
Pauls Stradins Clinical Univeristy Hospital
Riga , Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas
Mexico (1)
Christus Muguerza Hospital Sur
Monterrey , Nuevo León
Нидерландия (1)
Elisabeth-TweeSteden Ziekenhuis
Tilburg , North Brabant
Полша (1)
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan , Greater Poland Voivodeship
Румъния (1)
Spitalul de Oncologie Monza
Bucharest , Bucharest
Russia (1)
Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
Barnaul , Altayskiy Kray
Сърбия (1)
Clinical Hospital Center Zvezdara
Belgrade , Beograd
Словакия (1)
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica , Banská Bystrica Region
Южна Корея (1)
Yonsei University-Wonju Severance Christian Hospital
Wŏnju , Kang-won-do
Швейцария (1)
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern , Canton of Bern
Турция (1)
Eskisehir Osmangazi University
Eskişehir , Eskişehir
Ukraine (1)
Medical Center Family Medicine Clinic
Dnipro , Dnipropetrovsk Oblast
Великобритания (1)
Addenbrooke's Hospital
Cambridge , Cambridgeshire
САЩ (1)
Digestive Health Specialists
Dothan , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
22.06.2020
Крайна дата
01.04.2027
Регистрационен номер
NCT04232553
Източник
anzctr
Запитване за медицински туризъм

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