A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
Study Purpose
This study designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).
Recruitment Criteria
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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years - 80 Years |
| Gender | All |
- - Inclusion Criteria - Participants from Study AMAC (NCT02589665) or AMBG (NCT #:TBD) who have had at least one study drug administration and have not had early termination of study drug.
- - Female participants must agree to contraception requirements.
- - Exclusion Criteria - Participants must not have developed a new condition, including cancer in the originator study.
- - Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study - Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
- - Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Trial Details
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This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03519945 |
|
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Belgium, Canada, Croatia, Czechia, Denmark, France, Georgia, Hungary, Ireland, Italy, Japan, Latvia, Lithuania, Malaysia, Moldova, Republic of, Netherlands, Poland, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States |
|
The disease, disorder, syndrome, illness, or injury that is being studied. |
Ulcerative Colitis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Care Access Research - Salt Lake City
Salt Lake City, Utah, 84124
Status
Not yet recruiting
Address
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
Status
Recruiting
Address
Columbia University Medical Center
New York, New York, 10032
Status
Recruiting
Address
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446
Status
Not yet recruiting
Address
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Delta Research Partners LLC
Monroe, Louisiana, 71201
Status
Recruiting
Address
Borland Groover Clinic
Jacksonville, Florida, 32256 6004
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Address
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452
Status
Recruiting
Address
Inland Empire Liver Foundation
Rialto, California, 92377
Status
Not yet recruiting
Address
University of California San Diego
La Jolla, California, 92093
International Sites
Status
Recruiting
Address
John Radcliffe Hospital
Headington, Oxfordshire, OX3 9DU
Status
Not yet recruiting
Address
Diaservis Ltd
Zaporizhzhia, , 69035
Status
Not yet recruiting
Address
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, , 21005
Status
Not yet recruiting
Address
Medical Center "Health Clinic" LLC
Vinnitsa, , 21009
Status
Not yet recruiting
Address
Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo, Ukr.med.stom.acad.
Poltava, , 36011
Status
Not yet recruiting
Address
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta
Lviv, , 79007
Status
Not yet recruiting
Address
Lviv Regional Clinical Hospital
Liviv, , 79010
Status
Not yet recruiting
Address
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, , 04107
Status
Not yet recruiting
Address
International Institute of Clinical Trials LLC
Kyiv, , 02091
Status
Not yet recruiting
Address
CI Kherson CCH
Kherson, , 73000
Status
Not yet recruiting
Address
GI L.T. Malaya TI Namsu
Kharkiv, , 61039
Status
Not yet recruiting
Address
Ivano-Frankivsk State Medical University
Ivano-Frankivsk, , 76018
Status
Not yet recruiting
Address
Instituto de Ciencias medicas
Alicante, , 03004
Status
Not yet recruiting
Address
General Hospital "Djordje Joanovic"
Zrenjanin, , 23000
Status
Not yet recruiting
Address
Clinical Center Zemun
Zemun, , 11080
Status
Not yet recruiting
Address
General Hospital Sremska Mitrovica
Sremska Mitrovica, , 22000
Status
Not yet recruiting
Address
General Hospital Dr Radivoj Simonovic
Sombor, , 25000
Status
Not yet recruiting
Address
Clinical Center Nis
Nis, , 18000
Status
Not yet recruiting
Address
Clinical Hospital Center Kragujevac
Kragujevac, , 34000
Status
Not yet recruiting
Address
Military Medical Academy
Belgrade, , 11000
Status
Not yet recruiting
Address
Military Medical Academy
Belgrade, , 11000
Status
Not yet recruiting
Address
Clinical Center Zvezdara
Belgrade, , 11000
Status
Not yet recruiting
Address
Clinical Center of Serbia
Belgrade, , 11000
Status
Not yet recruiting
Address
Clinical Center Bezanijska Kosa
Belgrade, NAP, 11000
Status
Not yet recruiting
Address
SHI of Yaroslavl Region Clinical Hospital #8
Yaroslavl, , 150030
Status
Not yet recruiting
Address
Railway clinical hospital
St. Petersburg, , 195271
Status
Not yet recruiting
Address
Medical Institute REAVIZ
Samara, , 443001
Status
Not yet recruiting
Address
SBIH City Clinical Hospital #31
Saint-Petersburg, , 197110
Status
Not yet recruiting
Address
LLC Gastroenterology Centre Expert
Saint-Petersburg, , 197110
Status
Not yet recruiting
Address
SPb SBIH "City Mariinskaya Hospital"
Saint-Petersburg, , 194104
Status
Not yet recruiting
Address
SBIH of Moscow "City Clinical Hospital #24 "
Moscow, , 127015
Status
Not yet recruiting
Address
Treatment and Rehabilitation Center of the Ministry of Health of the RF
Moscow, , 125367
Status
Not yet recruiting
Address
Irkutsk State Medical Academy of Continuing Education
Irkutsk, , 664049
Status
Not yet recruiting
Address
LLC MA New Hospital
Ekaterinburg, , 620109
Status
Recruiting
Address
Vivamed
Warszawa, , 03-580
Status
Recruiting
Address
Endoskopia sp z o. o
Sopot, , 81-756
Status
Recruiting
Address
Centrum Medyczne Lux Med Poradnia Gastroenterologii
Rzeszow, , 35-068
Status
Recruiting
Address
NZOZ Gastromed
Lublin, , 20-582
Status
Recruiting
Address
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, , 31009
Status
Recruiting
Address
NZOZ ALL-MEDICUS, Zaklad Gastroenterologii
Katowice, , 40-659
Status
Recruiting
Address
Szpital Miejski Sw. Jana Pawla II
Elblag, , 82-300
Status
Recruiting
Address
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, , 85-168
Status
Recruiting
Address
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Status
Recruiting
Address
Republican Clinical Hospital
Chisinau, , MD2025
Status
Not yet recruiting
Address
University Malaya Medical Centre
Kuala Lumpur, , 59100
Status
Not yet recruiting
Address
University Malaya Medical Centre
Kuala Lumpur, , 59100
Status
Not yet recruiting
Address
Hospital Universiti Sains Malaysia
Kelantan, , 16150
Status
Not yet recruiting
Address
Pusat Perubatan University Kebangsaan Malaysia
Cheras, Kuala Lumpur, , 56000
Status
Not yet recruiting
Address
Hospital Ampang
Ampang, Selangor, 68000
Status
Not yet recruiting
Address
Hospital Raja Perempuan Zainab II
Kota Bahru, Kelantan, 15586
Status
Not yet recruiting
Address
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460
Status
Not yet recruiting
Address
Vilnius University Hospital Santariskiu Clinics
Vilnius, , LT-08661
Status
Recruiting
Address
Vilniaus Universiteto Ligonines Santariskiu Klinikos
Vilnius, , LT-08661
Status
Recruiting
Address
Respublikine Panevezio Ligonine
Panevezys, , LT-35144
Status
Recruiting
Address
Klaipeda Seamen's Hospital
Klaipeda, , 92288
Status
Recruiting
Address
Republic Hospital of Klaipeda
Klaipeda, , 92231
Status
Not yet recruiting
Address
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, , 50161
Status
Recruiting
Address
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, , 50161
Status
Recruiting
Address
Riga Eastern Clinical University Hospital
Riga, , LV-1038
Status
Recruiting
Address
Digestive Diseases Center "Gastro"
Riga, , LV-1006
Status
Recruiting
Address
Health Center 4, Affiliate Diagnostic Center
Riga, , LV-1003
Status
Recruiting
Address
Pauls Stradins Kliniska Universitates Slimnica
Riga, , LV-1002
Status
Not yet recruiting
Address
Okayama University Hospital
Okayama, , 700-8558
Status
Not yet recruiting
Address
Kumamoto University Hospital
Kumamoto, , 860-8556
Status
Recruiting
Address
Toyama Prefectural Central Hospital
Toyama-Shi, Toyama, 930-8550
Status
Recruiting
Address
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073
Status
Recruiting
Address
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Status
Not yet recruiting
Address
Kitasato University Kitasato Institute Hospital
Minato-Ku, Tokyo, 108 8642
Status
Not yet recruiting
Address
Showa University Koto Toyosu Hospital
Koto-ku, Tokyo, 135 8577
Status
Recruiting
Address
Tokyo Medical And Dental University Hospital
Bunkyo-ku, Tokyo, 113-8519
Status
Not yet recruiting
Address
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Status
Not yet recruiting
Address
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku, Tokyo-To, 162 8655
Status
Not yet recruiting
Address
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498
Status
Not yet recruiting
Address
Matsuaikai Matsuda Hospital
Hamamatsu-shi, Shizuoka-Ken, 4328061
Status
Not yet recruiting
Address
Tokitokai Tokito Clinic
Saitama-shi, Saitama-Ken, 336 0963
Status
Not yet recruiting
Address
Kumagaya General Hospital
Kumagaya-shi, Saitama-Ken, 360-8567
Status
Recruiting
Address
Saga-Ken Medical Center Koseikan
Saga-shi, Saga, 840 8571
Status
Not yet recruiting
Address
NHO Osaka National Hospital
Osaka-shi, Osaka, 540 0006
Status
Recruiting
Address
Kinshukai Infusion Clinic
Osaka-shi, Osaka, 530 0011
Status
Not yet recruiting
Address
Osaka University Hospital
Suita-shi, Osaka-Fu, 5650871
Status
Not yet recruiting
Address
Shinseikai Sai Gastroenterology, proctology
Fujidera-shi, Osaka Fu, 583 0027
Status
Not yet recruiting
Address
Ishida Clinic of IBD and Gastroenterology
Oita-shi, Oita-Ken, 870 0823
Status
Not yet recruiting
Address
Nagaoka Chuo General Hospital
Nagaoka-shi, Niigata, 940-8653
Status
Not yet recruiting
Address
Takagi Clinic
Sendai-shi, Miyagi-Ken, 981 3213
Status
Not yet recruiting
Address
Mie University Hospital
Tsu, Mie, 514-8507
Status
Not yet recruiting
Address
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Status
Not yet recruiting
Address
Showa University Northern Yokohama Hospital
Yokohama, Kanagawa, 224-8503
Status
Recruiting
Address
Matsushima Clinic
Yokohama, Kanagawa, 220 0045
Status
Recruiting
Address
Kawasaki Municipal Kawasaki Hospital
Kawasaki, Kanagawa, 210-0013
Status
Recruiting
Address
Gokeikai Ofuna Chuo Hospital
Kamakura-shi, Kanagawa, 247-0056
Status
Not yet recruiting
Address
Sankikai Yokohama Shin midori General Hospital
Yokohama-shi, Kanagawa-Ken, 226 0025
Status
Not yet recruiting
Address
Kitasato University Hospital
Sagamihara-shi, Kanagawa-ken, 252-0375
Status
Recruiting
Address
Sameshima Hospital
Kagoshima-shi, Kagoshima, 892-0846
Status
Not yet recruiting
Address
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa, 760-8557
Status
Not yet recruiting
Address
Takamatsu Red Cross Hospital
Takamatsu, Kagawa, 760-0017
Status
Recruiting
Address
The Hospital of Hyogo College of Medecine
Nishinomiya, Hyogo, 663-8501
Status
Not yet recruiting
Address
Aoyama Clinic GI Endoscopy & IBD Center
Kobe-shi, Hyogo-Ken, 650 0015
Status
Not yet recruiting
Address
Tokushukai Sapporo Higashi Tokushukai Hospital
Sapporo-shi, Hokkaido, 065 0033
Status
Recruiting
Address
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo-shi, Hokkaido, 060 0033
Status
Not yet recruiting
Address
Keijinkai Teine Keijinkai Hospital
Sapporo-shi, Hokkaido, 0068555
Status
Not yet recruiting
Address
Tokushukai Sapporo Tokushukai Hospital
Sapporo-shi, Hokkaido, 004 0041
Status
Not yet recruiting
Address
Hiroshima University Hospital
Hiroshima-shi, Hiroshima-ken, 734-8551
Status
Not yet recruiting
Address
NHO Mito Medical Center
Ibaraki-machi, HigaShiibaraki-Gun, 311 3193
Status
Not yet recruiting
Address
Takasaki General Medical Center
Takasaki, Gunma, 370-0829
Status
Not yet recruiting
Address
Gunma University Hosptial
Maebashi, Gunma, 371-8511
Status
Not yet recruiting
Address
NHO Kyoto Medical Center
Kyoto-shi, Fushimi-ku, 612 8555
Status
Not yet recruiting
Address
Hidaka Coloproctology Clinic
Kurume-shi, Fukuoka-Ken, 839 0809
Status
Not yet recruiting
Address
Yukinoseibokai St. Mary's Hospital
Kurume-shi, Fukuoka-Ken, 830 8543
Status
Not yet recruiting
Address
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka-Ken, 818 8502
Status
Not yet recruiting
Address
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, 802-0077
Status
Not yet recruiting
Address
Toho University School of Medicine, Sakura Hospital
Sakura, Chiba, 285-8741
Status
Not yet recruiting
Address
NHO Hirosaki National Hospital
Hirosaki-shi, Aomori-Ken, 036 8545
Status
Not yet recruiting
Address
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, 470-1192
Status
Not yet recruiting
Address
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, 480-1195
Status
Not yet recruiting
Address
A.O. San Giovanni di Dio e Ruggi D'Aragona
Salerno, , 84131
Status
Not yet recruiting
Address
Azienda Ospedlaliero-Univeristaria Pisana - Ospedale di Cisanello - Gastroenterologia
Pisa, , 56124
Status
Not yet recruiting
Address
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, , 41124
Status
Not yet recruiting
Address
Policlinico S. Orsola Malpighi - Universita di Bologna
Bologna, , 40138
Status
Not yet recruiting
Address
Ospedale Sandro Pertini
Roma, RM, 00157
Status
Not yet recruiting
Address
Beaumont Hospital
Dublin, , DUBLIN 9
Status
Recruiting
Address
Javorszky Odon Hospital
Vac, , 2600
Status
Recruiting
Address
Clinfan Szolgaltato Kft.
Szekszard, , 7100
Status
Not yet recruiting
Address
SZTE I. sz. Belgyogyaszati Klinika
Szeged, , 6720
Status
Not yet recruiting
Address
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, , 1125
Status
Not yet recruiting
Address
Dr. Rethy Pal Korhaz es Rendelointezet
Bekescsaba, Bekes, 5600
Status
Recruiting
Address
LLC ARENSIA Exploratory Medicine
Tbilisi, , 0112
Status
Not yet recruiting
Address
CHU St Etienne Hopital Nord
Saint Etienne Cedex 2, , 42055
Status
Not yet recruiting
Address
Nyborg Sygehus - OUH
Nyborg, , 5800
Status
Recruiting
Address
Hepato-gastroenterologie HK, s.r.o.
Hradec Kralove, , 50012
Status
Not yet recruiting
Address
University Hospital Center Sestre Milosrdnice
Zagreb, , 10000
Status
Not yet recruiting
Address
Polyclinic Bonifarm
Zagreb, , 10000
Status
Not yet recruiting
Address
Clinical Hospital Sveti Duh
Zagreb, , 10000
Status
Not yet recruiting
Address
CHC Zagreb
Zagreb, , 10000
Status
Not yet recruiting
Address
University Hospital Split
Split, , 21000
Status
Not yet recruiting
Address
University Hospital Center Osijek
Osijek, , 31000
Status
Recruiting
Address
McGill University
Montreal, Quebec, H3G 1A4
Status
Recruiting
Address
CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital
Montreal, Quebec, H1T 2M4
Status
Not yet recruiting
Address
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Status
Recruiting
Address
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , 3000
Status
Recruiting
Address
Universitair Ziekenhuis Gent
Gent, , 9000
Status
Recruiting
Address
St Vincents Hospital Melbourne
Fitzroy, Victoria, 3065
Status
Recruiting
Address
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Status
Not yet recruiting
Address
Mautalen Salud e Investigación - Servicio de Endocrinología
Ciudad Autonoma De Buenos Air, , C1128AAF
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