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Active (not recruiting) Phase 3 NCT04232553

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

Phase 3 – large-scale trial before approval
Conditions: Crohn's Disease

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 30
Argentina (1)
DOM Centro de Reumatología
Buenos Aires
Australia (1)
Concord Repatriation General Hospital
Concord , New South Wales
Belgium (1)
Imelda General Hospital
Bonheiden , Antwerpen
Brazil (1)
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador , Estado de Bahia
Canada (1)
Gastroenterology and internal medicine research institute
Edmonton , Alberta
China (1)
Anhui Provincial Hospital
Hefei , Anhui
Croatia (1)
Klinički bolnički centar Zagreb
Zagreb , City of Zagreb
Czech Republic (1)
Vojenská Nemocnice Brno
Brno , Brno-město
Denmark (1)
Gastroenterologische Praxis Balsiger, Seibold & Partner
Aalborg , North Denmark
France (1)
Chu Saint Eloi
Montpellier , Languedoc-Roussillon
Hungary (1)
Synexus Magyarország Kft
Gyula , Bekes County
India (1)
Gujarat Hospital - Gastro & Vascular Centre
Surat , Gujarat
Israel (1)
Sheba Medical Center
Ramat Gan , Central District
Italy (1)
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan , Lombardy
Japan (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
Netherlands (1)
Elisabeth-TweeSteden Ziekenhuis
Tilburg , North Brabant
Poland (1)
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan , Greater Poland Voivodeship
Romania (1)
Spitalul de Oncologie Monza
Bucharest , Bucharest
Russia (1)
Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
Barnaul , Altayskiy Kray
Serbia (1)
Clinical Hospital Center Zvezdara
Belgrade , Beograd
Slovakia (1)
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica , Banská Bystrica Region
South Korea (1)
Yonsei University-Wonju Severance Christian Hospital
Wŏnju , Kang-won-do
Switzerland (1)
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern , Canton of Bern
Turkey (1)
Eskisehir Osmangazi University
Eskişehir , Eskişehir
Ukraine (1)
Medical Center Family Medicine Clinic
Dnipro , Dnipropetrovsk Oblast
United Kingdom (1)
Addenbrooke's Hospital
Cambridge , Cambridgeshire
United States (1)
Digestive Health Specialists
Dothan , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.06.2020
Completion date
01.04.2027
Registry ID
NCT04232553
Source
anzctr
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