Eine Studie zu LY3471851 bei wahrnehmenden mit mittelschwerer bis schwer aktiver Colitis ulcerosa (UC)

Eine adaptive, randomisierte, doppelblinde, placebokontrollierte Phase-2-Studie zu LY3471851 (NKTR 358) bei Patienten mit mittelschwerer bis schwer aktiver Colitis ulcerosa

Sponsoren

Hauptsponsor: Eli Lilly and Company

Quelle Eli Lilly and Company
Kurze Zusammenfassung

indipendente

detaillierte Beschreibung

indipendente

Gesamtstatus Verwirklichung
Anfangsdatum 2021-03-22
Fertigstellungstermin 2024-07-07
Primäres Abschlussdatum 2023-07-30
Phase Phase 2
Studientyp Interventionell
Primärer Ausgang
Messen Zeitfenster
indipendente Woche 12
Sekundäres Ergebnis
Messen Zeitfenster
Percentage of Participants Who Achieved Clinical Response Week 12
indipendente Woche 12
indipendente Woche 12
indipendente Woche 12
indipendente Woche 12
indipendente Woche 12
indipendente Woche 12
indipendente Baseline, Woche 12
indipendente Woche 12
Einschreibung 200
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: LY3471851

Beschreibung: administered SC

Armgruppenetikett: LY3471851 (High Dose)

Anderer Name: NKTR-358

Interventionsart: Arzneimittel

Interventionsname: LY3471851

Beschreibung: indipendente

Armgruppenetikett: indipendente

Anderer Name: NKTR-358

Interventionsart: Arzneimittel

Interventionsname: Placebo

Beschreibung: indipendente

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

indipendente

Geschlecht:

Alle

Mindestalter:

18 Jahre

Maximales Alter:

75 Jahre

Gesunde Freiwillige:

Nein

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
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) Study Director Eli Lilly and Company
Gesamtkontakt

Nachname: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Telefon: 1-317-615-4559

Email: [email protected]

Ort
Einrichtung: Status: Kontakt: Ermittler:
Dedicated Clinical Research | Litchfield Park, Arizona, 85340, United States Recruiting 623-512-4340 Connie C Hsu Principal Investigator
University of California San Diego | La Jolla, California, 92037, United States Not yet recruiting 858-246-2572 William Sandborn Principal Investigator
I.H.S. Health, LLC | Kissimmee, Florida, 34741, United States Recruiting 407-530-4370 Syed Lateef Principal Investigator
Gastroenterology Associates of Pensacola, PA | Pensacola, Florida, 32503, United States Recruiting 850-436-4536 Frederic Newman Principal Investigator
Atlantic Digestive Health Institute | Morristown, New Jersey, 07960, United States Not yet recruiting 973-971-7507 Razvan Arsenescu Principal Investigator
The Ohio State University Wexner Medical Center | Columbus, Ohio, 43210, United States Not yet recruiting 614-366-0471 Anita Afzali Principal Investigator
Biopharma Informatic, Inc. | Houston, Texas, 77084, United States Recruiting 2819443610 James Arthur Maher Principal Investigator
Southern Star Research Institute, LLC | San Antonio, Texas, 78229, United States Recruiting 210-581-2812 Jeff S Bullock Principal Investigator
Care Access Research - Ogden | Ogden, Utah, 84403, United States Recruiting 801-475-3680 Chad Gonzales Principal Investigator
The Gastroenterology Group, P.C. | Reston, Virginia, 20191, United States Recruiting 703-766-2650 Emil Valle Principal Investigator
DOM- Centro de Reumatologia | Caba, Buenos Aires, 1111, Argentina Not yet recruiting 541121203180 Fernanda Dorado Principal Investigator
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC | Caba, Buenos Aires, C1431FWO, Argentina Not yet recruiting 541148088200 Juan Sebastian Lasa Principal Investigator
Mautalen Salud e Investigacion-Centro de Osteopatías Médicas | Ciudad Autonoma De Buenos Air, Buenos Aires, C1128AAF, Argentina Not yet recruiting 541145143410 Emiliano Tron Principal Investigator
Instituto Medico Elsa Perez SRL (IMEP) | Ciudadela, Buenos Aires, 1702, Argentina Not yet recruiting 541146538023 Sandra Covanti Principal Investigator
Centro Médico Privado de Reumatología | Tucumán, T4000AXL, Argentina Not yet recruiting 03514200180 Eduardo Ezequiel Martinez Principal Investigator
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Paratus Clinical Research Brisbane | Albion, Queensland, 4010, Australia Not yet recruiting 61735062444 Sheetal Bull Principal Investigator
Mater Adult Hospital Brisbane | South Brisbane, Queensland, 4700, Australia Not yet recruiting 61731638195 Yoon-Kyo An Principal Investigator
Royal Adelaide Hospital | Adelaide, South Australia, 5000, Australia Not yet recruiting 61870740000 Peter Bampton Principal Investigator
Université Libre de Bruxelles - Hôpital Erasme | Brussels, 1070, Belgium Not yet recruiting 3225555377 Anneline Cremer Principal Investigator
AZ Maria Middelares | Gent, 9100, Belgium Not yet recruiting 3292467141 Didier Baert Principal Investigator
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Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS | Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil Not yet recruiting 555133336031 Julio Cesar Razera Principal Investigator
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas | Campinas, Sao Paulo, 13060-904, Brazil Not yet recruiting 551933438600 Joaquim Simões Neto Principal Investigator
Pesquisare | Santo Andre, Sao Paulo, 09080-110, Brazil Not yet recruiting 551144273339 Alexander de Sa Rolim Principal Investigator
Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual | Sao Paulo, SP, 04039-004, Brazil Not yet recruiting 551150840931 Debora Dourado Poli Principal Investigator
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP | Botucatu, São Paulo, 18618-687, Brazil Not yet recruiting 551438801171 Ligia Yukie Sassaki Principal Investigator
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo, São Paulo, 09715-090, Brazil Not yet recruiting 551144688183 Sandra Di Felice Boratto Principal Investigator
Hepatogastro | Sao Paulo, 04543-001, Brazil Not yet recruiting 551134373228 Rodrigo Andrey Rocco Principal Investigator
Gastroenterology Research, Nova Scotia Health Authority | Halifax, Nova Scotia, B3H1V7, Canada Not yet recruiting 9024735111 Michael Stewart Principal Investigator
London Health Science Centre - Victoria Hospital | London, Ontario, N6A 5W9, Canada Not yet recruiting 5196675977 Terry Ponich Principal Investigator
CISSS de la Montérégie - Centre Hôpital Charles-Le Moyne | Greenfield Park, Quebec, J4V2H1, Canada Not yet recruiting 4504665000 Andrew Wisniewski Principal Investigator
McGill University | Montreal, Quebec, H3G 1A4, Canada Not yet recruiting 5149341934 Peter Lakatos Principal Investigator
The First Affiliated Hospital of Anhui Medical University | HefeiCity, Anhui, 230022, China Not yet recruiting Naizhong Hu Principal Investigator
First affiliated Hospital of Sun Yat-Sen University | Guangzhou, Guangdong, 510080, China Not yet recruiting 862087332200 Baili Chen Principal Investigator
The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou, Guangdong, 510655, China Not yet recruiting 863502405878 Xiang Gao Principal Investigator
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech | Wu Han, Hubei, 430030, China Not yet recruiting De'an Tian Principal Investigator
Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan, Hubei, 430022, China Not yet recruiting Xiaohua Hou Principal Investigator
Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai, Shanghai, 200025, China Not yet recruiting Duowu Zou Principal Investigator
Sir Run Run Shaw Hospital | Hangzhou, Zhejiang, 310018, China Not yet recruiting Qian Cao Principal Investigator
Gregar s.r.o. | Olomouc, 779 00, Czechia Not yet recruiting 420585428910 Jan Gregar Principal Investigator
I. Interni klinika FN Plzen | Plzen-Lochotin, 304 60, Czechia Not yet recruiting 420377103322 Jana Kozeluhova Principal Investigator
A-Shine s.r.o. | Plzen, 31200, Czechia Recruiting 420777242101 Lubos Janu Principal Investigator
Nemocnice Slaný | Slany, 274 01, Czechia Recruiting 420312575316 Martin Peterka Principal Investigator
CHU De Grenoble Hopital Albert Michallon | Grenoble Cedex 09, 38043, France Not yet recruiting 0476766150 Bruno Bonaz Principal Investigator
Acad. F. Todua Medical Center - Research Institute of Clinical Medicine | Tbilisi, 0112, Georgia Not yet recruiting 995599117976 Tengiz Telia Principal Investigator
Medical Center: Medinvestment | Tbilisi, 0186, Georgia Not yet recruiting 995599333836 Irakli Khmaladze Principal Investigator
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt | Frankfurt am Main, Hessen, 60590, Germany Not yet recruiting 496963015154 Irina Blumenstein Principal Investigator
Medizinische Hochschule Hanover | Hannover, Niedersachsen, 30625, Germany Not yet recruiting 00495115329427 Ursula Seidler Principal Investigator
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt | Halle (Saale),, Sachsen Anhalt, 06108, Germany Not yet recruiting 0049 345 299 760 Lars Fechner Principal Investigator
Gastroenterologische Spezialpraxis | Berlin, 10318, Germany Not yet recruiting 0049305293310 Michael Mroß Principal Investigator
Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen | Hamburg, 20251, Germany Not yet recruiting 004940 4232651 50 Stefanie Howaldt Principal Investigator
Clinexpert SMO | Budapest, 1033, Hungary Recruiting 36703622417 Zsanett Heringh Principal Investigator
Obudai Egeszsegugyi Centrum Kft | Budapest, 1036, Hungary Recruiting 36304455682 Csaba Fulop Principal Investigator
Bugat Pal Korhaz | Gyongyos, 3200, Hungary Recruiting 3637312491 Gyula Horvat Principal Investigator
Clinfan Szolgaltato Kft. | Szekszard, 7100, Hungary Recruiting 36302777114 Agnes Salamon Principal Investigator
Shree Giriraj Hospital | Rajkot, Gujarat, 360004, India Not yet recruiting 09825077472 Chetan Mehta Principal Investigator
Midas Multispecilaity Hopsital Pvt Ltd | Ramdaspeth, Nagpur, 440010, India Not yet recruiting 91 7720033280 Shrikant Mukewar Principal Investigator
S.R. Kalla Hospital | Jaipur, Rajasthan, 302001, India Not yet recruiting 911415112042 Mukesh Kalla Principal Investigator
Shri Mahant Indiresh Hospital | Dheradun, Uttarakhand, 248001, India Not yet recruiting 911352522100 Pankaj Dixit Principal Investigator
Post Graduate Institute of Medical Education & Research | Chandigarh, 160012, India Not yet recruiting 911722747585 Jayanta Samanta Principal Investigator
Apollo Speciality Hospital | Chennai, 6000, India Not yet recruiting 04424354956 Ganesh Subramanian Principal Investigator
Gujarat Hospital - Gastro and Vascular Centre | Gujarat, 395009, India Not yet recruiting 02612782020 Saumin Shah Principal Investigator
Gandhi Hospital | Telangana, 500003, India Not yet recruiting 04027505566 Porika Shravan Kumar Principal Investigator
Soroka Medical Center | Beer Sheva, 8410101, Israel Not yet recruiting 972507413471 Arik Segal Principal Investigator
Galilee Medical Center - Internal A | Nahariya, 22100, Israel Not yet recruiting 97249107748 Nimer Assy Principal Investigator
Kaplan Medical Center | Rehovot, 7610001, Israel Not yet recruiting 97289441587 Ehud Melzer Principal Investigator
Fukuoka University Chikushi Hospital | Chikushino-shi, Fukuoka-Ken, 818 8502, Japan Recruiting 81120023812 Takashi Hisabe Principal Investigator
Tokushukai Sapporo Tokushukai Hospital | Sapporo-shi, Hokkaido, 004 0041, Japan Recruiting 81120023812 Toshifumi Ashida Principal Investigator
Sapporo Medical University Hospital | Sapporo, Hokkaido, 060-8543, Japan Not yet recruiting 81120023812 Hiroshi Nakase Principal Investigator
Sameshima Hospital | Kagoshima-shi, Kagoshima, 892-0846, Japan Recruiting 81120023812 Nobuaki Nishimata Principal Investigator
Shinseikai Sai Gastroenterology, proctology | Fujiidera-shi, Osaka Fu, 583 0027, Japan Recruiting 81120023812 Souken Sai Principal Investigator
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Matsuaikai Matsuda Hospital | Hamamatsu-shi, Shizuoka-Ken, 4328061, Japan Recruiting 81120023812 Kazuhiko Kawakami Principal Investigator
Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku, Tokyo-To, 162 8655, Japan Recruiting 81120023812 Junichi Akiyama Principal Investigator
Toyama Prefectural Central Hospital | Toyama-Shi, Toyama, 930-8550, Japan Recruiting 81120023812 Koichiro Matsuda Principal Investigator
Fukuoka University Hospital | Fukuoka, 814-0180, Japan Recruiting 81120023812 Fumihito Hirai Principal Investigator
Yamagata University Hospital | Yamagata, 990-9585, Japan Not yet recruiting 81120023812 Yasuhiko Abe Principal Investigator
Ajou University Hospital | Suwon-si, Gyeonggi-do, 443380, Korea, Republic of Not yet recruiting Sung Jae Shin Principal Investigator
Seoul St. Mary's Hospital | Seoul, Korea, 06591, Korea, Republic of Not yet recruiting Bo-In Lee Principal Investigator
Inje University Haeundae Paik Hospital | Busan, 48108, Korea, Republic of Recruiting 820517970009 Tae-oh Kim Principal Investigator
Yonsei University Wonju Severance Christian Hospital | Gangwon-do, 26426, Korea, Republic of Not yet recruiting Hyun-Sook Kim Principal Investigator
Samsung Medical Center | Seoul, 06351, Korea, Republic of Recruiting YoungHo Kim Principal Investigator
Pauls Stradins Kliniska Universitates Slimnica | Riga, LV-1002, Latvia Not yet recruiting 3717069509 Aldis Pukitis Principal Investigator
Pauls Stradins Kliniska Universitates Slimnica | Riga, LV-1002, Latvia Not yet recruiting 3717069509 Juris Pokrotnieks Principal Investigator
Health Center 4, Affiliate Diagnostic Center | Riga, LV-1003, Latvia Not yet recruiting 37126588961 Ilona Vilkoite Principal Investigator
Szpital Miejski Sw. Jana Pawla II | Elblag, 82-300, Poland Not yet recruiting 48552394450 Krzysztof Niezgoda Principal Investigator
WIP Warsaw IBD Point Profesor Kierkus | Warszawa, 00-728, Poland Not yet recruiting 48500111648 Jaroslaw Kierkus Principal Investigator
Vivamed | Warszawa, 03-580, Poland Not yet recruiting 48226185950 Robert Edward Petryka Principal Investigator
ETG Zamosc | Zamosc, 22-400, Poland Not yet recruiting 0048721055855 Katarzyna Wojcik Principal Investigator
SC Pelican SRL | Oradea, Bihor, 410469, Romania Not yet recruiting 40359804343 Alin-Horea Suta Principal Investigator
SC Med Life SA | Bucuresti, 010719, Romania Not yet recruiting 40212094030 Ion-Eugeniu Craciun Principal Investigator
SC Centrul Medical Sana SRL | Bucuresti, 011025, Romania Not yet recruiting 40212128222 Nicoleta Claudia Cimpoeru Principal Investigator
Spital Clinic Colentina | Bucuresti, Romania Not yet recruiting 40213173245 Radu Bogdan Mateescu Principal Investigator
Spitalul Clinic Judetean de Urgenta Cluj | Cluj-Napoca, 400006, Romania Not yet recruiting 40264599596 Dan Lucian Dumitrascu Principal Investigator
S.C. Materna Care S.R.L. | Timisoara, 300645, Romania Not yet recruiting 40721523258 Adriana Tudora Principal Investigator
LLC Olla-Med | Moscow, 105554, Russian Federation Not yet recruiting 74951059905 Pavel Makarchuk Principal Investigator
Moscow Clinical Research Center | Moscow, 111123, Russian Federation Not yet recruiting 74953043072 Oleg Knyazev Principal Investigator
First Moscow State Medical University | Moscow, 119435, Russian Federation Not yet recruiting 84996860016 Inna Tulina Principal Investigator
Open Joint Stock Company Clinical and Diagnostic Center Euromedservice | Moscow, Russian Federation Not yet recruiting 74957816006 Elena Anikina Principal Investigator
LLC Novosibirsk GastroCenter | Novosibirsk, 630007, Russian Federation Not yet recruiting 73833323359 Ekaterina Valuyskikh Principal Investigator
The University Clinic of OSMU | Omsk, 644050, Russian Federation Not yet recruiting 73812655670 Galina Nechaeva Principal Investigator
Rostov State Medical University | Rostov-on-Don, 344022, Russian Federation Not yet recruiting 88632719705 Alexander Tkachev Principal Investigator
SPb SBIH "City Mariinskaya Hospital" | Saint-Petersburg, 194104, Russian Federation Not yet recruiting 78126050303 Ksenia Vyutrikh Principal Investigator
Academician I.P. Pavlov First St-Petersburg State Medical University | St-Petersburg, 197022, Russian Federation Not yet recruiting 78123386667 Oksana Shchukina Principal Investigator
GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health | St. Petersburg, 195067, Russian Federation Not yet recruiting 79616127712 Igor Bakulin Principal Investigator
FNsP FDRoosevelta Banska Bystrica | Banska Bystrica, 97517, Slovakia Not yet recruiting Jozef Balaz Principal Investigator
ENDOMED s.r.o. | Kosice, 04013, Slovakia Not yet recruiting Miroslav Fedurco Principal Investigator
Medical Center of LLC Medical Center Clinic of Family Medicine | Dnipro, Ukraine Recruiting 380562310310 Yana Shapovalova Principal Investigator
International Institute of Clinical Trials LLC | Kyiv, 02091, Ukraine Not yet recruiting 380800211298 Svitlana Skybalo Principal Investigator
Medical Centre CONSILIUM MEDICAL | Kyiv, 04050, Ukraine Recruiting 380442470927 Oksana Gerasymenko Principal Investigator
Communal Non-Commercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital | Liviv, 79010, Ukraine Not yet recruiting 380676753303 Yaroslav Zborivskyy Principal Investigator
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta | Lviv, 79007, Ukraine Recruiting 38032264308 Olha Ivanishyn Principal Investigator
Communal Enterprise "Odesa Regional Clinical Hospital" | Odesa, 65000, Ukraine Not yet recruiting 380674810508 Andriy Yurkiv Principal Investigator
A. Novak Transcarpathian Regional Clinical Hospital | Uzhgorod, 88018, Ukraine Not yet recruiting 380312615101 Yaroslava Rishko Principal Investigator
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia, 21029, Ukraine Not yet recruiting 380432437212 Halyna Tomashkevych Principal Investigator
Vinnytsia War Veterans Regional Clinical Hospital | Vinnytsia, Ukraine Not yet recruiting 380432550794 Valerii Ivanov Principal Investigator
Diacenter LLC | Zaporizhzhia, 69104, Ukraine Not yet recruiting 380612965685 Yevgen Poplyonkin Principal Investigator
Royal Derby Hospital | Derby, Derbyshire, DE22 3DT, United Kingdom Not yet recruiting 1332133272 Said Din Principal Investigator
Whipps Cross University Hospital | Leytonstone, London, E11 1NR, United Kingdom Not yet recruiting 02085395522 Syed Hoque Principal Investigator
York Hospital | York, North Yorkshire, YO31 8HE, United Kingdom Not yet recruiting 01904631313 Gerry Robins Principal Investigator
Guys/St. Thomas Hospital | London, Surrey, SE1 9RT, United Kingdom Not yet recruiting 02071882498 Mark Samaan Principal Investigator
St. George's University Hospitals NHS Foundation Trust | London, SW17 0QT, United Kingdom Not yet recruiting 442087251206 Richard Pollok Principal Investigator
Standort Länder

Argentina

Australia

Belgium

Brazil

Canada

China

Czechia

France

Georgia

Germany

Hungary

India

Israel

Japan

Korea, Republic of

Latvia

Poland

Romania

Russian Federation

Slovakia

Ukraine

United Kingdom

United States

Überprüfungsdatum

2021-05-01

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert Nein
Anzahl der Waffen 3
Armgruppe

Etikette: LY3471851 (High Dose)

Art: Experimental

Beschreibung: Stage 1 LY3471851 given subcutaneously (SC) Stage 2 LY3471851 multiple doses to be confirmed

Etikette: LY3471851 (niedrige Dosis)

Art: Experimental

Beschreibung: indipendente

Etikette: Placebo

Art: Placebo-Komparator

Beschreibung: indipendente

Akronym INSTRUCT-UC
Studiendesign Info

Zuweisung: Zufällig

Interventionsmodell: Parallele Zuordnung

Hauptzweck: Behandlung

Maskierung: Doppel (Teilnehmer, Besetzt)

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