A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

Who is this study for? Patients with moderately to severely active ulcerative colitis
What treatments are being studied? Mirikizumab
Status: Completed
Location: See all (376) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Digestive Health Specialists of the Southeast
Dothan
Arizona
Dcr-Pi, Pc
Litchfield Park
Maricopa Integrated Health System
Phoenix
Physicians Research Group
Tempe
California
Valley Gastroenterology
Arcadia
Care Access Research
Berkeley
Om Research, LLC
Lancaster
California Medical Research Associates
Northridge
Clinical Applications Laboratories, Inc.
San Diego
UCSF Medical Center at Mission Bay
San Francisco
Florida
Direct Helpers Research Center
Hialeah
Nature Coast Clinical Research, LLC
Inverness
SIH Research, LLC
Kissimmee
Research Associates of South Florida, LLC
Miami
Wellness Clinical Research
Miami Lakes
Center for Interventional Endoscopy
Orlando
Clintheory Healthcare
Orlando
Gastroenterology Associates of Pensacola, PA
Pensacola
Florida Medical Clinic LLC
Zephyrhills
Georgia
Digestive Healthcare of Georgia
Atlanta
Idaho
Grand Teton Research Group
Idaho Falls
Illinois
NorthShore University HealthSystem
Evanston
Indiana
Indiana University School of Medicine
Indianapolis
Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka
Louisiana
Texas Digestive Disease Consultants
Baton Rouge
Delta Research Partners LLC
Monroe
Nola Research Works, LLC
New Orleans
Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield
Henry Ford Health System
Novi
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming
Huron Gastroenterology Associates
Ypsilanti
Minnesota
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth
Mississippi
Care Access Research LLC
Jackson
Digestive Health Specialists
Tupelo
North Carolina
University of North Carolina Center for Inflammatory Bowel Disease
Chapel Hill
Carolina Digestive Diseases and Endoscopy Center
Greenville
New York
Northwell Health
Great Neck
Weill Cornell Medical College
New York
Ohio
Paramount Medical Research
Middleburg Heights
Care Access - Youngstown
Poland
Oklahoma
Central Sooner Research
Norman
University of Oklahoma Health Sciences Center
Oklahoma City
Pennsylvania
Digestive Disease Associates
Wyomissing
South Dakota
Midwest Medical Care
Sioux Falls
Tennessee
Gastro One
Germantown
Galen Medical Group
Hixson
Texas
Digestive Health Associates of Texas
Garland
Biopharma Informatic, LLC
Houston
Houston Methodist Research Ins
Houston
Gastroenterology Research of San Antonio
San Antonio
Southern Star Research Institute, LLC
San Antonio
Texas Digestive Disease Consultants
Southlake
Utah
Care Access Research LLC - Salt Lake City
Ogden
Virginia
Emeritas Research Group
Leesburg
The Gastroenterology Group, P.C.
Reston
Carilion Clinic
Roanoke
Wisconsin
Wisconsin Center for Advanced Research
Milwaukee
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
Caba
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma De Buenos Air
Hospital Privado Centro Medico de Cordoba SA
Cordoba
CER Instituto Medico
Quilmes
Fundación de Estudios Clínicos
Rosario
Centro de Investigaciones Médicas Tucuman
San M. De Tucuman
C.I.C.E. 9 de Julio
San Miguel De Tucumán
Australia
Royal Adelaide Hospital
Adelaide
Box Hill Hospital Outpatients
Box Hill
Princess Alexandra Hospital
Harlow
Melbourne Gastrointestinal Investigation Unit (MGIU)
Malvern
Coastal Digestive Health
Maroochydore
The Alfred Hospital
Melbourne
The Royal Melbourne Hospital
Parkville
Mater University Hospital
South Brisbane
Austria
Medizinische Universität Innsbruck
Innsbruck
Universitätsklinikum Salzburg
Salzburg
Medical University of Vienna
Vienna
Belgium
AZ Klina
Brasschaat
Universitair Ziekenhuis Gent
Gent
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven
Centre Hospitalier de Wallonie Picarde - Site Notre Dame
Tournai
Canada
West Edmonton Diabetes Center
Edmonton
Centre de santé et de services sociaux Champlain-Charles-Le Moyne
Greenfield Park
University of Western Ontario
London
Victoria Hospital
London
Hopital Maisonneure-Rosemount
Montreal
Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
Montreal
GI Research Institute
Vancouver
The Gordon and Leslie Diamond Health Care Centre
Vancouver
PerCuro Clinical Research
Victoria
China
West China Hospital, Sichuan University
Chengdu
The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
Chongqing
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou
Sir Run Run Shaw Hospital
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Med
Hangzhou
Anhui Provincial Hospital
Hefei City
The First Affiliated Hospital of Anhui Medical University
Hefei City
Jilin Central General Hospital
Jilin
Qilu Hospital of Shandong University
Jinan
Shandong Provincial Hospital
Jinan
Xiangya Hospital Central South University
Kaifu District
Kunming Medical College Affiliated First Hospital
Kunming
The First People's Hospital of Yunnan Province
Kunming
Liaocheng People's Hospital
Liaocheng
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing
Zhongda Hospital Southeast University
Nanjing
Jiangxi Pingxiang People's Hospital
Pingxiang
The Affiliated Hospital of Qingdao University
Qingdao
Renji Hospital Affliated to Shanghai Jiaotong University
Shanghai
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai
Taian City Central Hospital
Taian
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou
Renmin Hospital of Wuhan University
Wuhan
Tongji Hospital of Tongji University
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Denmark
Herlev and Gentofte Hospital
Herlev
Zealand University Hospital Køge
Køge
France
CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
Amiens Cedex
CHU Tours - Hôpital Trousseau
Chambray Les Tours
Hôpital Beaujon
Clichy
CHU Lille - Hôpital Claude Huriez
Lille Cedex
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille Cedex 20
CHRU de Montpellier-Hopital St Eloi
Montpellier Cedex 5
Hopital L'Archet 2
Nice Cedex
Hopital Saint-Louis
Paris
Centre Hospitalier de Pau
Pau
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac Cedex
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
Pierre Benite Cedex
Robert Debre Hospital
Reims
CHU de Saint Etienne Hopital Nord
Saint Priest En Jarez
Hopital de Hautepierre - Service d'Hépatogastroentérolgie
Strasbourg Cedex
CHRU Nancy Brabois - Hôpital d'Enfants
Vandoeuvre Les Nancy
Germany
Charité Campus Virchow-Klinikum
Berlin
Krankenhaus Waldfriede
Berlin
Städtisches Klinikum Brandenburg
Brandenburg
Studiengesellschaft BSF Unternehmergesellschaft
Halle (saale)
Universitätsklinikum Halle
Halle (saale)
HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
Hamburg
Medizinische Hochschule Hanover
Hannover
Gemeinschaftspraxis Dr. Peter Uebel
Ludwigshafen Am Rhein
Internistische Praxisgemeinschaft
Weyhe
Hungary
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred
Óbudai Egészségügyi Centrum
Budapest
Semmelweis Egyetem
Budapest
Debreceni Egyetem Klinikai Kozpont
Debrecen
Endomedix Diagnosztikai Központ - Miskolc
Miskolc
Karolina Korhaz-Rendelointezet
Mosonmagyarovar
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
Szeged
CLINFAN Szolgáltató Kft
Szekszard
Jávorszky Ödön Kórház
Vác
India
Bangalore Medical College and Research Institute
Bangalore
M S Ramaiah Medical College and Hospitals
Bangalore
Apollo Research and Innovations, Apollo Hospitals International Ltd
Gandhinagar
Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
Hyderabad
Gandhi Hospital
Hyderabad
SR Kalla Memorial Gastro & General Hospital
Jaipur
King George Medical University
Lucknow
Dayanand Medical College and Hospital
Ludhiana
Midas Multispeciality Hospital Pvt.Ltd.
Nagpur
Escorts Heart Institute and Research Centre Ltd
New Delhi
Poona Medical Foundation. Ruby Hall Clinic
Pune
Shree Giriraj Multispeciality Hospital
Rajkot
Nirmal Hospital Pvt Ltd.
Surat
Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
Wardha
Ireland
Beaumont Hospital, Dublin
Dublin
Israel
Shaare Zedek Medical Center
Bait Vagan
Soroka Medical Center - Pediatric Outpatient Clinic
Beer-sheva
Galilee Medical Center Department of Internal Medicine A
Nahariya
Kaplan Medical Center
Rehovot
Tel Aviv Sourasky Medical Center
Tel Aviv
King Fahad Medical City
Zerifin
Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia
Azienda ospedaliero-universitaria Mater Domini
Catanzaro
Azienda Ospedaliero Universitaria San Martino
Genova
Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
Milano
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena
Azienda Ospedaliera Universitaria Pisana
Pisa
Presidio di Rho
Rho
Policlinico Gemelli - Università Cattolica del Sacro Cuore
Roma
Ospedale Sandro Pertini
Rome
Istituto Clinico Humanitas
Rozzano
Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
San Donato Milanese
Ospedale Mauriziano Umberto I
Torino
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Torre
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
Udine
Japan
Asahikawa City Hospital
Asahikawa
Tokyo Medical and Dental University Hospital
Bunkyō
Juntendo University Hospital
Bunkyo-ku
Fukuoka University Chikushi Hospital
Chikushino
Mitsui Memorial Hospital
Chiyoda-ku
Sai Gastroenterologist Proctology
Fujiidera
Fukuoka University Hospital
Fukuoka
Matsuda Hospital
Hamamatsu-shi
National Hospital Organization Hirosaki National Hospital
Hirosaki
Hiroshima University Hospital
Hiroshima
NHO Mito Medical Center
Ibaraki-machi
Sameshima Hospital
Kagoshima
Ofuna Central Hospital
Kamakura
Kawasaki Municipal Hospital
Kawasaki
Kitakyushu Municipal Medical Center
Kitakyusyu-shi
Aoyama Clinic GI Endoscopy & IBD Center
Kobe-shi
Showa University Koto Toyosu Hospital
Koto-ku
Kumagaya General Hospital
Kumagaya-shi
Kumamoto University Hospital
Kumamoto-shi
Hidaka Coloproctology Clinic
Kurume-shi
National Hospital Organization Kyoto Medical Center
Kyoto
Gunma University Hospital
Maebashi
Kitasato University Kitasato Institute Hospital
Minato-ku
Kyorin University Hospital
Mitaka
Aichi Medical University Hospital
Nagakute-shi
Nagaoka Chuo General Hospital
Nagaoka-shi
Ishida Clinic of IBD and Gastroenterology
Oita-shi
Okayama University Hospital
Okayama
Infusion Clinic
Osaka-shi
NHO Osaka National Hospital
Osaka-shi
Saga-Ken Medical Center Koseikan
Saga-shi
Tokitokai Tokito Clinic
Saitama
Toho University Sakura Medical Center
Sakura
Sapporo Higashi Tokushukai Hospital
Sapporo
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo-shi
Tokushukai Sapporo Tokushukai Hospital
Sapporo-shi
Takagi Clinic - Sendai
Sendai-shi
Jichi Medical University Hospital
Shimotsuke-shi
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-ku
JHCO Tokyo Yamate Medical Center
Shinjuku-ku
Kagawa Prefectural Central Hospital
Takamatsu
National Hospital Organization Takasaki General Medical Centar
Takasaki
Toyama Prefectural Central Hospital
Toyama
Fujita Health University
Toyoake
Mie University Hospital
Tsu
Showa University Northern Yokohama Hospital
Yokohama
Yokohama City University Medical Center
Yokohama
Sankikai Yokohama Shin midori General Hospital
Yokohama-shi
Latvia
Digestive Diseases Center Gastro
Riga
Pauls Stradins Clinical Univeristy Hospital
Riga
Riga Eastern Clinical University Hospital
Riga
Lithuania
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas
Klaipeda Seamen's Hospital
Klaipeda
Republic Hospital of Klaipeda
Klaipeda
Respublikine Panevezio ligonine
Panevezys
Vilnius University Hospital Santariskiu Clinics
Vilnius
Malaysia
Hospital Ampang
Ampang
Universiti Sains Malaysia
Kubang Kerian
University Malaya Medical Centre
Lembah Pantai
Mexico
Scientia Investigacion Clinica S.C.
Chihuahua
Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
Culiacan
Centro de Investigación Clínica Acelerada
Mexico City
Sociedad de Metabolismo y Corazon
Veracruz
Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan
Netherlands
Amsterdam UMC, locatie AMC
Amsterdam
St Elisabeth Ziekenhuis
Tilburg
Bernhoven Ziekenhuis
Uden
UMC Utrecht, Dept. of Internal Medicine, MDL
Utrecht
Poland
Promedica Dental Clinic
Bedzin
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz
All-Medicus
Katowice
Topolowa Medicenter
Krakow
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin
ZOZ Gastromed
Lublin
Medicenter Nowy Targ
Nowy Targ
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn
KO-Med Centrum Medyczne
Straszów
SONOMED Centrum Medyczne
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin
Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
Torun
NZOZ Formed
Wadowice
NZOZ Vivamed
Warsaw
Centrum Medyczne NeuroProtect
Warszawa
Centrum Zdrowia MDM
Warszawa
Warsaw IBD Point Profesor Kierkus
Warszawa
LexMedica
Wroclaw
PlanetMed Sp.z o.o.
Wroclaw
ETG Zamość
Zamosc
Republic of Korea
Dong-A University Hospital
Busan
Inje University Haeundae Paik Hospital
Busan
Yeungnam Univeristy Medical Center
Daegu
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon
Asan Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Kyung Hee University Hospital
Seoul
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University Health System
Wonju-si
Romania
CCBR Clinical Research
Bucharest
Hifu Terramed Conformal SRL
Bucuresti
Institutul Clinic Fundeni
Bucuresti
MedLife Grivita
Bucuresti
Spitalul Clinic Colentina
Bucuresti
Spital Pelican Oradea
Oradea
Russian Federation
Multidisciplinary Medical Clinic Anthurium
Barnaul
Medical and Sanitary Division of Severstal
Cherepovets
LLC MA New Hospital
Ekaterinburg
Scientific Centre of Reconstructive and Restorative Surgery
Irkutsk
Alliance Biomedical URAL Group
Izhevsk
Clinical Trials Center of Medical Institute
Kaliningrad
State Autonomous Institution of Healthcare Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
Kazan
SIH Kemerovo Regional Clinical Hosptial
Kemerovo
Medical rehabilitation center
Moscow
Nizhny Novgorod Regional Hospital N.A. Semashko
Nizhny Novgorod
Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
Nizhny Novgorod
LLC Medicine Center SibNovoMed
Novosibirsk
Novosibirski Gastrocenter
Novosibirsk
Clinical Diagnostic Center Ultramed
Omsk
Karelia Republican Hospital V.A. Baranova
Petrozavodsk
Rostov State Medical University
Rostov-on-don
Saint Petersburg State Medical University n.a. Pavlov I.P.
Saint Petersburg
Scientific research center ECO-security
Saint Petersburg
Non-state Healthcare Institution Roadway Clinical Hospital of OJSC Russian Railways
Saint-petersburg
Pokrovskaya Municipal Hospital
Saint-petersburg
SBIH City Clinical Hospital #31
Saint-petersburg
Medical Institute REAVIZ
Samara
City Mariinskaya Hospital
St. Petersburg
Stavropol State Medical University
Stavropol
Yaroslavl Municipal HI Clinical Hospital #8
Yaroslavl
Serbia
Clinical Hospital Center Zvezdara
Belgrade
University Medical Center Bezanijska kosa
Belgrade
Clinical Center Kragujevac Gastroenterohepatology Clinic
Kragujevac
Regional Hospital Dr Radivoj Simonovic Sombor
Sombor
Sremska Mitrovica Health Centre
Sremska Mitrovica
General Hospital Djordje Joanovic
Zrenjanin
Slovakia
Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
Banska Bystrica
Univerzitna nemocnica Bratislava
Bratislava
KM Management
Nitra
Gastro
Prešov
Endomed, s.r.o.
Vranov N. Toplou
Spain
Instituto de Ciencias Médicas
Alicante
Hospital De Fuenlabrada
Fuenlabrada
Hospital Universitari de Girona
Girona
Hospital Universitario Juan Ramon Jimenez
Huelva
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruña
Hospital De Gran Canaria Dr. Negrin
Las Palmas De Gran Canaria
Hospital Universitario La Paz
Madrid
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitari Son Espases
Palma De Mallorca
Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
Sagunto
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Universitario Virgen Del Rocio
Sevilla
Switzerland
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern
Inselspital Bern
Berne
Kantonsspital St.Gallen
St.gallen
UniversitätsSpital Zürich
Zürich
Taiwan
China Medical University Hospital
Taichung
Health management center
Taipei
Turkey
Ege Universitesi Hastanesi
Izmir
Kocaeli University Medical Faculty Hospital
Izmit
Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
Kadıkoy
Antalya Egitim ve Arastırma Hastanesi
Kocaeli
Mersin University Medical Faculty
Yenişehir
Ukraine
Ivano-Frankivsk Regional Clinical Hospital
Ivano-frankivsk
City Clinical Hospital No. 2
Kharkiv
GI L.T. Malaya TI Namsu
Kharkiv
Kharkiv City Student Hospital
Kharkiv
Kherson City Clinical Hospital
Kherson
Medical Center of Limited Liability Company Medical Center Consilium Medical
Kiev
Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
Kropyvnytskyi
Communal institution of the Kyiv Regional Council Kyiv Regional Clinical Oncology Dispensary
Kyiv
Communal institution of the Kyiv Regional Council Kyiv Regional Clinical Oncology Dispensary
Kyiv
Kyiv Municipal Clinical Hospital #1
Kyiv
Lviv Railway Clinical Hospital
Lviv
Lviv Regional Endocrinology Dispensary
Lviv
Municipal non-profit enterprise Lviv Territorial Medical Union Multidisciplinary Clinical Hospital of Em -T
Lviv
Communal Enterprise Odesa Regional Clinical Hospital
Odesa
Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
Poltava
A. Novak Transcarpathian Regional Clinical Hospital
Uzhgorod
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia
MCIC MC LLC Health Clinic
Vinnytsia
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia
M.I. Pyrogov Regional Clinical Hospital
Vinnytsya
Diaservis - Medical and Diagnostic Center
Zaporizhia
Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
Zaporizhzhia
United Kingdom
Fairfield General Hospital
Bury
St Thomas' Hospital
Great Maze Pond
St James's University Hospital
Leeds
Whipps Cross University Hospital
London
Queens Hospital
Romford
Morriston Hospital
Swansea
Time Frame
Start Date: 2018-10-19
Completion Date: 2024-12-13
Participants
Target number of participants: 1177
Treatments
Placebo_comparator: Maintenance Period: Miri Induction Responder (IR) - Placebo (PBO) Subcutaneous (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.
Experimental: Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
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.
Other: Maintenance Period: PBO IR - PBO SC
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.
Other: Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
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.
Other: Extended Induction: Induction Nonresponders - 300mg Miri IV
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.
Other: Open Label Maintenance: Delayed Responders - 200 mg Miri SC
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.
Authors
Stepan Suchanek, Thomas V Ballard, Daniel M Van Handel, Gregory P Gaspard, Tasha Boone, Michael Weiss, Ricardo McCall, Keith Sultan, Connie C Hsu, COLLEEN M SCHMITT, Zamir Brelvi, Curtis Baum, John E Lowe, Douglas C Wolf, Armando De Feria, Matthew D McCollough, Kevin M Cronley, Manuel Fernandez, Maithili Chitnavis, James Arthur Maher, Mariquit Sendelbach, Jonathan Rieber, Christian D Stone, Mustafa Kathawala, Sharyle Fowler, William J Provance, Murthy Badiga, Andrew Gentry, Sara Llerena, Chad Gonzales, Lilani P Perera, Lawrence Cohen, Divesh Anireddy, Nirmal Kaur, Clint E Behrend, Mark Gerich, Andria M Mushahwar, Ronald P Fogel, Tejinder S Glamour, Navin Barot, Laurie Grossberg, Richard F Harty, Kenolisa C Onwueme, Lucky Flores, Paul Lamb, Glenn Freed, Sara N Horst, Jayaprakash Kamath, Henry Scheuller, Vijay Narayen, Syed T Mumtaz, Edmundo Justino, Muhammad Irfan, Charles Bernstein, Jean F Colombel, Timothy Ritter, Mark E Lamet, Alex Sherman, James C kao, Kenneth L Johnson, Marc Kudisch, Udayakumar Navaneethan, David R Cave, Monte Troutman, Timothy Zisman, Niaz Ausaf, Marc Ferrante, Ervin Eaker, Frederick W Schnure, Vijayalakshmi S Pratha, Sashidhar V Sagi, Nikhil V Inamdar, Stephen B Hanauer, Melvin B Heyman, Shahid Wahid, Doo-Sang Cho, Darren N Seril, Javier Sobrado, Ahmad Cheema, Rizwana H. Mohseni, Victor R Araya, William Holderman, Jorge Paoli-Bruno, Sartaj M Arora, Mark Kogan, Scott Clark, Adam Palance, Jonathan Siegel, Eugene F Yen, Brian Moloney, Tuba Esfandyari, Bashar Attar, Manoj Mehta, Souheil Moussly, Richard Rood, Jatinder S Pruthi, Mazen Issa, Jonathon C Chapman, Elias A Tarakji, Prodyot Ghosh, Chandar Singaram, Samuel Davidoff, Bruce A Salzberg, Maria Hatara, Anurekha Chadha, Umesh Choudhry, Richard S Bloomfeld, Peder J Pedersen, Peter Uebel, Calin Arimie, Glenn D Littenberg, Najm M Soofi, Raymond Cross, Priyesh Mehta, Ellen J Scherl, Jonathan F Williams, Mark Eisner, Keng-Yu Chuang, Jason K Hou, Noah Zinkin, Anil R Balani, Brigid Boland, Steven Cohen, Joaquin Diego, Stephen Felton, George Aaron Duvall, Guy W Neff, Bincy Abraham, David W Morris, Joseph G Cheatham, Michael D Kurtz, John Zak, karen Simon, Myung Choi, Jack Heneisen, Daniel Geenen, William J Sandborn, Robert Leventhal, Felix P Tiongco, Yasmin Alishahi, Michele Young, Emil Valle, Jakob Begun, Yoon-Tae Jeen, Aldona Mularczyk, Aleksandar Nagorni, Jonathan MacDonald, Laurence Picon, Stéphane Nancey, Ariadne Desjeux, Xavier Roblin, Matthieu Allez, Romain Altwegg, Pierre Desreumaux, Tanja Kühbacher, Emma Wesley, Jens Walldorf, Craig Mowat, Aminda De Silva, David Laharie, Xavier Treton, Carsten Büning, Ursula Seidler, Mathurin Fumery, Alexandre Aubourg, Florian Obermeier, Stefanie Howaldt, Jochen Klaus, Jens Encke, Anja Schirbel, Stefan Lueth, Benoit Coffin, Elisabeth Schnoy, Andreas Sturm, Laurent Peyrin-Biroulet, Xavier Hebuterne, Matthias Banasch, Camille Zallot, Robert Koch, Lilla Lakner, Ziad H Younes, Allan G Coates, Mrinal Garg, Nicholas P Martinez, Phillip J Goldstein, Samuel Idarraga, Vivek Huilgol, Satinder Gill, Richard K Gilroy, Geoffrey D Block, Sayed Yossef, Yaron Langman, Steven Cohn, George P Christophi, Thomas C Welton, Animesh Jain, Paul A Hellstern, Michael R Galambos, Sarah Glover, Scott Lee, Eduard Burnevich, Tryambak Samanta, Carlos Fernando de Magalhaes Francesconi, Estanislao Jesus Gomez, Avinash Balekuduru, Tetsuya Ishida, Wilson Catapani, Can Gonen, Zdena Zadorova, Bugra Tolga Konduk, Marinko Marusic, Zsolt Tulassay, Jean-Charles Grimaud, Jonghun Lee, Sho Takagi, Eran Goldin, Abel Novillo, Mitsushige Shibatoge, Audrey Weber, Assy Nimer, Ginette Fotsing, Kenji So, Naresh Bansal, Ana Teresa Pugas Carvalho, Omer Ozutemiz, Ebubekir Senates, Yijuan Ding, Sadettin Hulagu, Wouter Van Moerkercke, Robert Laheij, Jozsef Hamvas, Jan Fallingborg, Tibor Hlavaty, Tokuma Tanuma, Ehud Melzer, Bhabadev Goswami, Robert Edward Petryka, Laszlo Herszenyi, Agnes Salamon, Vasiliy Trofimov, Chia-Hung Tu, Hyo-Jong Kim, Keijiro Sunada, Baljinder Salh, Simona Bataga, Vedran Tomasic, Radu B Mateescu, Ivan Chopey, Mukul Rastogi, Toshifumi Ashida, Sergii Shevchuk, Peter Bampton, Satoshi Motoya, Noriyuki Horiki, Ozlen Atug, Maciej Gonciarz, Abhijit Chandra, Ja Seol Koo, Hirotada Akiho, Sung Kook Kim, Guy Aumais, Juan De Paula, Nobuo Toda, Vladimir Borzan, Marina Osipenko, Naizhong Hu, Yusuf Erzin, cheng-Hsin Chu, Nitin Pai, Shinji Katsushima, Faisal Batwa, Xueli Ding, Olga Niewiadomski, Kavitha Subramaniam, Juris Pokrotnieks, Kaiguang Zhang, Herma Fidder, Yi Jiang, Akash Shukla, Martin Buckley, Gregory Rosenfeld, Ching-Pin Lin, Vijendra Kirnake, Hideaki Naoe, Pinaki Roy, Rustam Abdulkhakov, Xiaoping Zou, Henning Nielsen, Shrikant Mukewar, Saroj Kant Sinha, Dragan Popovic, Guoxin Zhang, Naoyuki Uragami, Istvan Altorjay, Paolo Gionchetti, Maria Klopocka, David Kevans, Ivars Tolmanis, Zhihua Ran, Marco Daperno, Baruch Ovadia, Terry Ponich, Dino Tarabar, Francesca Rogai, Domingo Balderramo, Tarkan Karakan, Amarender Puri, Rupa Banerjee, Gediminas Kiudelis, Masaru Nakano, Noriyuki Ogata, Dean Tian, Igor Bakulin, Miles Sparrow, Yufang WANG, Shinichi Ogata, Signe Wildt, Tamas Molnar, Mark Lowenberg, Po-Li Wei, Timna Naftali, Jiing-Chyuan Luo, Kang-Moon Lee, Jacob Brodersen, Halis Simsek, Hideki Iijima, Gerald Holtmann, Jean-Marie Reimund, Maria Caterina Parodi, Dustin Loomes, Daniela Bartos, Vladimir Rafalskiy, Sung-Ae jung, Toshio Uraoka, Engin Altintas, Theodor Alexandru Voiosu, Sakiko Hiraoka, SungJae Shin, Shinji Tanaka, Erica Villa, Seong-Eun Kim, Maurizio Vecchi, Hong Guo, Takashi Hisabe, Jesse Siffledeen, Jaroslaw Kierkus, Eduardo Leo Carnerero, Abdulelah Almutairdi, Stephan Brand, Grazyna Rydzewska, Milan Lukas, Ruihua Shi, Xiaohua Hou, Mikio Kawai, Simone Saibeni, Luc Biedermann, Hisashi Ishida, Remo Panaccione, Walter Reinisch, Frank Seibold, Francesco Luzza, Reiko Kunisaki, Tadakazu Hisamatsu, Qian Cao, Abed Al Lehibi, Ida Normiha Hilmi, Sigal Fishman, Crispin Corte, Pieter Hindryckx, Tomoyoshi Shibuya, Naoki Ohmiya, Etienne Désilets, Jakob Seidelin, Alicia Maria Sambuelli, Zhengji Song, Chunxiao Chen, Roberta Pica, Katsuyoshi Matsuoka, Michal Lawinski, Yinglei Miao, Koichiro Matsuda, Kaoru Yokoyama, Shiro Nakamura, Zhihui Lin, Waqqas Afif, Liliana Simona Gheorghe, Finlay Macrae, Pascal Juillerat, Yongdong Wu, Jie Zhong, Jen-Wei Chou, Frank Wolfhagen, Antonio Gasbarrini, Ping Yao, Peng Yan, Carolina Ciacci, Takeshi Ishikawa, Rajib Sarkar, Britta Siegmund, Toshimitsu Fujii, Hong Shen, Yanqing Li, Atsuo Maemoto, Petar Svorcan, Fumihito Hirai, Hiroaki Ito, Hsu-Heng Yen, Peter Irving, Tomoki Inaba, Haim Shirin, Jimmy Limdi, Yan Chen, Wei-Chen Tai, Ajit Sood, Hale Akpinar, Zeljko Krznaric, Nobuo Aoyama, Alexander Bodelier, Stephan Boehm, Ayhan Hilmi Cekin
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Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov