A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Interleukin-23 (IL-23), IL-23p19, Inflammatory Bowel Disease
Eligibility Criteria
Inclusion Criteria:
- Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- If female, must meet the contraception requirements.
Exclusion Criteria:
- Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
- Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
- Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
- Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
- Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
- Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
Sites / Locations
- Digestive Health Specialists
- Dcr-Pi, Pc
- Maricopa Integrated Health System
- Physicians Research Group
- Valley Gastroenterology
- Care Access Research
- Om Research, LLC
- California Medical Research Associates
- Clinical Applications Laboratories, Inc.
- UCSF Medical Center at Mission Bay
- Direct Helpers Research Center
- Nature Coast Clinical Research, LLC
- SIH Research, LLC
- Wellness Clinical Research
- Columbus Clinical Services, LLC
- Research Associates of South Florida, LLC
- Center for Interventional Endoscopy
- Clintheory Healthcare
- Gastroenterology Associates of Pensacola, PA
- Florida Digestive Specialist
- Florida Medical Clinic LLC
- Digestive Healthcare of Georgia
- Grand Teton Research Group
- NorthShore University HealthSystem
- Indiana University School of Medicine
- Cotton-O'Neil Clinical Research Center, Digestive Health
- Texas Digestive Disease Consultants
- Delta Research Partners LLC
- Nola Research Works, LLC
- Clinical Research Institute of Michigan, LLC
- Henry Ford Health System
- Gastroenterology Associates of Western Michigan, P.L.C.
- Huron Gastroenterology Associates
- MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
- Gen1 Research - Gastroenterology & Nutrition, PC
- Northwell Health
- Weill Cornell Medical College
- University of North Carolina Center for Inflammatory Bowel Disease
- Carolina Digestive Diseases and Endoscopy Center
- Paramount Medical Research
- Care Access - Youngstown
- Central Sooner Research
- University of Oklahoma Health Sciences Center
- Care Access Research LLC
- Digestive Disease Associates
- Midwest Medical Care
- Gastro One
- Galen Medical Group
- Digestive Health Associates of Texas
- Houston Methodist Research Ins
- Biopharma Informatic, LLC
- Gastroenterology Research of San Antonio
- Southern Star Research Institute, LLC
- Texas Digestive Disease Consultants
- Care Access Research LLC - Salt Lake City
- Emeritas Research Group
- The Gastroenterology Group, P.C.
- Carilion Clinic
- Digestive Health Specialists
- Wisconsin Center for Advanced Research
- Centro de Investigaciones Metabólicas (CINME)
- Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
- CER Instituto Medico
- Fundación de Estudios Clínicos
- Centro de Investigaciones Médicas Tucuman
- C.I.C.E. 9 de Julio
- Hospital Privado Centro Medico de Cordoba SA
- Princess Alexandra Hospital
- Coastal Digestive Health
- Mater University Hospital
- Royal Adelaide Hospital
- Box Hill Hospital Outpatients
- Melbourne Gastrointestinal Investigation Unit (MGIU)
- The Alfred Hospital
- The Royal Melbourne Hospital
- Medizinische Universität Innsbruck
- Universitätsklinikum Salzburg
- Medical University of Vienna
- Universitair Ziekenhuis Gent
- Centre Hospitalier de Wallonie Picarde - Site Notre Dame
- AZ Klina
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
- West Edmonton Diabetes Center
- The Gordon and Leslie Diamond Health Care Centre
- GI Research Institute
- PerCuro Clinical Research
- Victoria Hospital
- University of Western Ontario
- Centre de santé et de services sociaux Champlain-Charles-Le Moyne
- Hopital Maisonneure-Rosemount
- Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
- Anhui Provincial Hospital
- The First Affiliated Hospital of Anhui Medical University
- Beijing Friendship Hospital Affiliate of Capital University
- Xiangya Hospital Central South University
- The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
- The First Hospital Affiliated to AMU (Southwest Hospital)
- Fujian Province Hospital
- The Sixth Affiliated Hospital, Sun Yat-Sen University
- The University of Hong Kong-Shenzhen Hospital
- Hainan General Hospital
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Renmin Hospital of Wuhan University
- Changzhou No.2 People's Hospital
- The Affiliated Drum Tower Hospital of Nanjing University
- Jiangsu Province Hospital of Chinese Medicine
- Jiangsu Province Hospital
- Zhongda Hospital Southeast University
- Nanjing Medical University - Nanjing Jiangning Hospital
- Jiangxi Pingxiang People's Hospital
- Jilin Central General Hospital
- The Second Hospital of Dalian Medical University
- Shengjing Hospital of China Medical University
- Qilu Hospital of Shandong University
- Liaocheng People's Hospital
- The Affiliated Hospital of Medical College Qingdao Univ
- Taian City Central Hospital
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
- Renji Hospital Affliated to Shanghai Jiaotong University
- West China Hospital of Sichuan University
- No.1 Hospital Affiliated to Xinjiang Medical University
- Kunming Medical College Affiliated First Hospital
- The First People's Hospital of Yunnan Province
- The Second Affiliated Hospital of Zhejiang University School of Med
- First Affiliated Hosp of College of Med, Zhejiang University
- Sir Run Run Shaw Hospital
- The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
- Tongji Hospital of Tongji University
- Vojenská Nemocnice Brno
- Fakultni nemocnice Kralovske Vinohrady
- Hepato-Gastroenterologie HK
- MUDr. Gregar, s.r.o.
- A-Shine
- MEDIENDO
- Fakultni Nemocnice u sv. Anny v Brne
- PreventaMed, s.r.o.
- ISCARE Clinical Centre
- Herlev and Gentofte Hospital
- Zealand University Hospital Køge
- Hopital de Hautepierre - Service d'Hépatogastroentérolgie
- Hopital Saint-Louis
- CHU Lille - Hôpital Claude Huriez
- Hôpital Beaujon
- Centre Hospitalier de Pau
- Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
- CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
- CHU Tours - Hôpital Trousseau
- Assistance Publique Hôpitaux de Marseille - Hôpital Nord
- CHRU de Montpellier-Hopital St Eloi
- Hopital L'Archet 2
- CHU Bordeaux - Hôpital Haut-Lévêque
- Robert Debre Hospital
- CHU de Saint Etienne Hopital Nord
- CHRU Nancy Brabois - Hôpital d'Enfants
- Medizinische Hochschule Hanover
- Gemeinschaftspraxis Dr. Peter Uebel
- Studiengesellschaft BSF Unternehmergesellschaft
- Universitätsklinikum Halle
- Charité Campus Virchow-Klinikum
- Krankenhaus Waldfriede
- Städtisches Klinikum Brandenburg
- HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
- Internistische Praxisgemeinschaft
- DRC Gyogyszervizsgalo Kozpont Kft.
- Jávorszky Ödön Kórház
- Óbudai Egészségügyi Centrum
- Semmelweis Egyetem
- Debreceni Egyetem Klinikai Kozpont
- Endomedix Diagnosztikai Központ - Miskolc
- Karolina Korhaz-Rendelointezet
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
- CLINFAN Szolgáltató Kft
- Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
- Escorts Heart Institute and Research Centre Ltd
- Apollo Research and Innovations, Apollo Hospitals International Ltd
- Shree Giriraj Multispeciality Hospital
- Nirmal Hospital Pvt Ltd.
- Bangalore Medical College and Research Institute
- M S Ramaiah Medical College and Hospitals
- Midas Multispeciality Hospital Pvt.Ltd.
- Poona Medical Foundation. Ruby Hall Clinic
- Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
- Dayanand Medical College and Hospital
- SR Kalla Memorial Gastro & General Hospital
- King George Medical University
- Fortis Hospital
- Gandhi Hospital
- Beaumont Hospital, Dublin
- Shaare Zedek Medical Center
- Soroka Medical Center - Pediatric Outpatient Clinic
- Galilee Medical Center Department of Internal Medicine A
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center
- Assaf Harofeh Medical Center
- Presidio di Rho
- Istituto Clinico Humanitas
- Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
- Ospedale Sandro Pertini
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
- Azienda ospedaliero-universitaria Mater Domini
- Azienda Ospedaliero Universitaria San Martino
- Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
- Azienda Ospedaliera Universitaria Policlinico de Modena
- Azienda Ospedaliera Universitaria Pisana
- Policlinico Gemelli - Università Cattolica del Sacro Cuore
- Ospedale Mauriziano Umberto I
- Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
- Aichi Medical University Hospital
- Fujita Health University Hospital
- National Hospital Organization Hirosaki General Medical Center
- Toho University Sakura Medical Center
- Kitakyushu Municipal Medical Center
- Hidaka Coloproctology Clinic
- Fukuoka University Chikushi Hospital
- Gunma University Hospital
- National Hospital Organization Takasaki General Medical Centar
- NHO Mito Medical Center
- Asahikawa City Hospital
- Tokushukai Sapporo Tokushukai Hospital
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
- Sapporo Higashi Tokushukai Hospital
- Aoyama Clinic GI Endoscopy & IBD Center
- Kagawa Prefectural Central Hospital
- Sankikai Yokohama Shin midori General Hospital
- Ofuna Central Hospital
- Kawasaki Municipal Hospital
- Yokohama City University Medical Center
- Showa University Northern Yokohama Hospital
- Kumamoto University Hospital
- Mie University Hospital
- Takagi Clinic - Sendai
- Nagaoka Chuo General Hospital
- Ishida Clinic of IBD and Gastroenterology
- Sai Gastroenterologist Proctology
- Infusion Clinic
- NHO Osaka National Hospital
- Saga-Ken Medical Center Koseikan
- Kumagaya General Hospital
- Matsuda Hospital
- Jichi Medical University Hospital
- Mitsui Memorial Hospital
- Center Hospital of the National Center for Global Health and Medicine
- Juntendo University Hospital
- Tokyo Medical and Dental University Hospital
- Showa University Koto Toyosu Hospital
- Kitasato University Kitasato Institute Hospital
- Kyorin University Hospital
- JHCO Tokyo Yamate Medical Center
- Fukuoka University Hospital
- Hiroshima University Hospital
- Sameshima Hospital
- National Hospital Organization Kyoto Medical Center
- Okayama University Hospital
- Tokitokai Tokito Clinic
- Toyama Prefectural Central Hospital
- Severance Hospital, Yonsei University Health System
- Kyung Hee University Hospital
- Dong-A University Hospital
- Kangbuk Samsung Hospital
- Asan Medical Center
- Samsung Medical Center
- The Catholic University of Korea, Daejeon St. Mary's Hospital
- Inje University Haeundae Paik Hospital
- Yeungnam Univeristy Medical Center
- Pauls Stradins Clinical Univeristy Hospital
- Digestive Diseases Center "Gastro"
- Riga Eastern Clinical University Hospital
- Respublikine Panevezio ligonine
- Hospital of Lithuanian University of Health Sciences Kaunas
- Republic Hospital of Klaipeda
- Klaipeda Seamen's Hospital
- Vilnius University Hospital Santariskiu Clinics
- Universiti Sains Malaysia
- University Malaya Medical Centre
- Hospital Ampang
- Centro de Investigación Clínica Acelerada
- Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
- Centro Para el Desarrollo de la Medicina y de Asistencia Med
- Scientia Investigacion Clinica S.C.
- Sociedad de Metabolismo y Corazon
- St Elisabeth Ziekenhuis
- Amsterdam UMC, locatie AMC
- Bernhoven Ziekenhuis
- UMC Utrecht, Dept. of Internal Medicine, MDL
- LexMedica
- Szpital Uniwersytecki Nr 2 w Bydgoszczy
- Centrum Medyczne Pratia Bydgoszcz
- ZOZ Gastromed
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
- NZOZ Vivamed
- Topolowa Medicenter
- Medicenter Nowy Targ
- NZOZ Formed
- Endoskopia Sp. z.o.o.
- SONOMED Centrum Medyczne
- All-Medicus
- Wojewodzki Specjalistyczny Szpital w Olsztynie
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
- Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
- Warsaw IBD Point Profesor Kierkus
- Centrum Zdrowia MDM
- Centrum Medyczne NeuroProtect
- PlanetMed Sp.z o.o.
- ETG Zamość
- Promedica Dental Clinic
- KO-Med Centrum Medyczne
- CCBR Clinical Research
- MedLife Grivita
- Spitalul Clinic Colentina
- Institutul Clinic Fundeni
- Hifu Terramed Conformal SRL
- Spital Pelican Oradea
- Scientific Centre of Reconstructive and Restorative Surgery
- Karelia Republican Hospital V.A. Baranova
- Nizhny Novgorod Regional Hospital N.A. Semashko
- Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
- Novosibirski Gastrocenter
- Rostov State Medical University
- Scientific research center ECO-security
- Multidisciplinary Medical Clinic "Anthurium"
- Medical and Sanitary Division of Severstal
- LLC MA New Hospital
- Alliance Biomedical URAL Group
- Clinical Trials Center of Medical Institute
- State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan"
- SIH Kemerovo Regional Clinical Hosptial
- Medical rehabilitation center
- LLC "Medicine Center SibNovoMed"
- Clinical Diagnostic Center Ultramed
- Saint Petersburg State Medical University n.a. Pavlov I.P.
- Pokrovskaya Municipal Hospital
- Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"
- SBIH City Clinical Hospital #31
- Medical Institute REAVIZ
- City Mariinskaya Hospital
- Stavropol State Medical University
- Yaroslavl Municipal HI Clinical Hospital #8
- Clinical Hospital Center Zvezdara
- University Medical Center "Bezanijska kosa"
- Regional Hospital Dr Radivoj Simonovic Sombor
- Sremska Mitrovica Health Centre
- General Hospital "Djordje Joanovic"
- Clinical Center Kragujevac Gastroenterohepatology Clinic
- KM Management
- Gastro
- Endomed, s.r.o.
- Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
- Univerzitna nemocnica Bratislava
- Hospital Universitario Virgen Del Rocio
- Hospital Universitario Central de Asturias
- Hospital Universitari Son Espases
- Hospital Universitario Marqués de Valdecilla
- Hospital De Fuenlabrada
- Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
- Instituto de Ciencias Médicas
- Hospital Universitari de Girona
- Hospital Universitario Juan Ramon Jimenez
- Complexo Hospitalario Universitario A Coruña, CHUAC
- Hospital De Gran Canaria Dr. Negrin
- Hospital Universitario La Paz
- Gastroenterologische Praxis Balsiger, Seibold & Partner
- Inselspital Bern
- Kantonsspital St.Gallen
- UniversitätsSpital Zürich
- China Medical University Hospital
- Health management center
- Antalya Egitim ve Arastırma Hastanesi
- Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
- Kocaeli University Medical Faculty Hospital
- Mersin University Medical Faculty
- Ege University Medicine of Faculty
- Ivano-Frankivsk Regional Clinical Hospital
- City Clinical Hospital No. 2
- Kherson City Clinical Hospital
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
- Lviv Railway Clinical Hospital
- Lviv Regional Endocrinology Dispensary
- Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"
- Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
- Diaservis - Medical and Diagnostic Center
- Kharkiv City Student Hospital
- GI L.T. Malaya TI Namsu
- Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
- Kyiv Municipal Clinical Hospital #1
- Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
- Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
- Communal Enterprise "Odesa Regional Clinical Hospital"
- A. Novak Transcarpathian Regional Clinical Hospital
- Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
- MCIC MC LLC Health Clinic
- CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
- M.I. Pyrogov Regional Clinical Hospital
- Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
- Queens Hospital
- Fairfield General Hospital
- St Thomas' Hospital
- Whipps Cross University Hospital
- Morriston Hospital
- St James's University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Other
Other
Other
Other
Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (SC)
Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
Maintenance Period: PBO IR - PBO SC
Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
Extended Induction: Induction Nonresponders - 300mg Miri IV
Open Label Maintenance: Delayed Responders - 200 mg Miri SC
Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
Participants who received PBO SC or 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40.