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A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
Official title: A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
882
Start Date
2025-10-01
Completion Date
2032-01-13
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Icotrokinra
Icotrokinra tablet will be administered orally.
Placebo
Placebo tablet will be administered orally.
Locations (301)
AZ Gastro Care
Chandler, Arizona, United States
Clinnova Research
Anaheim, California, United States
Southern California Research Center
Coronado, California, United States
Om Research LLC
Lancaster, California, United States
TLC Clinical Research Inc
Los Angeles, California, United States
GastroIntestinal Bioscience
Los Angeles, California, United States
Om Research LLC
Oxnard, California, United States
Clinical Applications Laboratories, Inc
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Nuvance Health Danbury Hospital
Danbury, Connecticut, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
American Institute of Research
Cutler Bay, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
GCP Clinical Research
Tampa, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, United States
Delta Research Partners, LLC
West Monroe, Louisiana, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Westchester Putnam Gastroenterology
Carmel, New York, United States
Manhattan Clinical Research LLC
New York, New York, United States
New York Gastroenterology Associates
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Gastro Intestinal Research Institute of Northern Ohio LLC
Westlake, Ohio, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, United States
The Oregon Clinic
Portland, Oregon, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Digestive Disease Associates
Rock Hill, South Carolina, United States
The University of Texas at Austin
Austin, Texas, United States
DFW Clinical Trials
Carrollton, Texas, United States
Victorium Clinical Research
Houston, Texas, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Blue Ridge Medical Research
Lynchburg, Virginia, United States
GEDYT
AAI, Argentina
Cer Instituto Medico
Buenos Aires, Argentina
Kynet Recoleta
Buenos Aires, Argentina
CIPREC
CABA, Argentina
Instituto de Investigaciones Clinicas T y T
Caba, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, Argentina
Sanatorio Maipu
Maipú, Argentina
HIGEA
Mendoza, Argentina
Monash Medical Centre
Clayton, Australia
Concord Repatriation General Hospital
Concord, Australia
St Vincents Hospital Melbourne
Fitzroy, Australia
Fiona Stanley Hospital
Murdoch, Australia
John Hunter Hospital
New Lambton Heights, Australia
Royal Melbourne Hospital
Parkville, Australia
Mater Hospital Brisbane
South Brisbane, Australia
CHU Saint-Pierre
Brussels, Belgium
UZ Brussel
Brussels, Belgium
AZ St. Lucas
Ghent, Belgium
Ghent University Hospital
Ghent, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium
CHwapi
Tournai, Belgium
Hospital das Clinicas do HC/UFMG
Belo Horizonte, Brazil
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Jaú, Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Canada
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, Canada
Viable Clinical Research
Kentville, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
London Digestive Disease Institute
London, Ontario, Canada
West GTA Research Inc
Mississauga, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, Canada
Clinique IMD
Montreal, Quebec, Canada
China Japan Friendship Hospital
Beijing, China
Capital Medical University, Beijing Friendship Hospital
Beijing, China
Changzhou No 2 Peoples Hospital
Changzhou, China
Chongqing General Hospital
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Affiliated Hospital of Hainan Medical University
Haikou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Heilongjiang Provincial Hospital
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Huizhou Central People's Hospital
Huizhou, China
Zhongda Hospital Southeast University
Nanjing, China
The First Affiliated Hospital of Ningbo University
Ningbo, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
The Second Affiliatted Hospital of Soochow University
Suzhou, China
Taian City Central Hospital
Taian, China
Meihekou Central Hospital
Tonghua, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The Central Hospital of Wuhan
Wuhan, China
Wuxi People s Hospital
Wuxi, China
Northern Jiangsu Peoples Hospital
Yangzhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, China
Fakultni nemocnice Brno
Brno, Czechia
Vojenska nemocnice Brno
Brno, Czechia
Nemocnice Ceske Budejovice
České Budějovice, Czechia
Centrum gastroenterologie a hepatologie s.r.o.
Kladno, Czechia
PreventaMed, s.r.o.
Olomouc, Czechia
Gastromedic, Ltd.
Pardubice, Czechia
AXON Clinical s.r.o.
Prague, Czechia
Clinoxus s r o
Prague, Czechia
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze
Praha 1- Mala Strana, Czechia
MUDr. Michal Konecny, Ph.D. s.r.o.
Přerov, Czechia
Centre Hospitalier de la Cote Basque
Bayonne, France
CHU de Clermont Ferrand - Site Estaing
Clermont-Ferrand, France
APHP - Hopital Henri Mondor
Créteil, France
Institut Prive MICI Clinique des Cedres
Échirolles, France
CHU de Lille Hopital Claude Huriez
Lille, France
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, France
CHU de Limoges Hopital Dupuytren
Limoges, France
GHI Le Raincy Montfermeil
Montfermeil, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, France
Jules Verne Clinic
Nantes, France
CHU de Nice Hopital de l Archet
Nice, France
Hopital Saint-Antoine
Paris, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, France
Hospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, France
CHU Toulouse - Hopital de Rangueil
Toulouse, France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, France
Universitaetsklinikum der RWTH Aachen
Aachen, Germany
Krankenhaus Waldfriede Mitte
Berlin, Germany
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, Germany
BSF Studiengesellschaft
Halle, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Praxisgemeinschaft Jerichow
Jerichow, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, Germany
Eugastro GmbH
Leipzig, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, Germany
Universitaetsmedizin Rostock
Rostock, Germany
Universitaetsklinikum Ulm
Ulm, Germany
Evangelismos S A
Athens, Greece
Alexandra General Hospital of Athens
Athens, Greece
University General Hospital of Heraklion
Heraklion, Greece
Theageneio Cancer Hospital
Thessaloniki, Greece
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
Békéscsaba, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
Budapest, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
Debrecen, Hungary
Szegedi Tudományegyetem Áok Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary
Clinfan Ltd. SMO
Szekszárd, Hungary
Szent Borbala Hospital Tatabanya
Tatabánya, Hungary
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
Surat, India
Haemek Medical Center
Afula, Israel
Assuta MC
Ashdod, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, Israel
Bnai Zion Medical Center
Haifa, Israel
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Galilee Medical Center
Nahariya, Israel
Schneider Children's Medical Center
Petah Tikva, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Ospedale San Raffaele di Milano
Milan, Italy
Ospedale Sacro Cuore Negrar-Verona
Negrar-Verona, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, Italy
Juntendo University Hospital Urayasu
Chiba, Japan
Ginza central clinic
Chūōku, Japan
Sai Gastroenterology Proctology
Fujiidera-shi, Japan
Fukui Prefectural Hospital
Fukui-shi, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, Japan
Gamagori City Hospital
Gamagōri, Japan
Matsuda Hospital
Hamamatsu, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, Japan
Hirosaki General Medical Center
Hirosaki, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, Japan
Kanazawa University Hospital
Kanazawa, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu, Japan
Kobe University Hospital
Kobe, Japan
Aoyama Naika Clinic
Kobe, Japan
Kumamoto University Hospital
Kumamoto, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Japan
Takano Hospital
Kumamoto, Japan
Kurume University Hospital
Kurume, Japan
Kyorin University Hospital
Mitaka, Japan
Takagi Clinic
Miyagi, Japan
Hyogo Medical University Hospital
Nishinomiya Shi, Japan
Nakagami Hospital
Okinawa, Japan
Kinshukai Infusion Clinic
Osaka, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Japanese Red Cross Osaka Hospital
Osaka, Japan
Oita Red Cross Hospital
Ōita, Japan
Sapporo Tokushukai Hospital
Sapporo, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, Japan
Yokohama City University Medical Center
Yokohama, Japan
Hospital Sultanah Bahiyah
Alor Star, Malaysia
Hospital Ampang
Ampang, Malaysia
Hospital Sultanah Aminah
Johor Bahru, Malaysia
Sultan Idris Shah Hospital
Kajang, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Maastricht UMC
Maastricht, Netherlands
Radboud Umcn
Nijmegen, Netherlands
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, Poland
Osrodek Badan Klinicznych CLINSANTE S C
Bydgoszcz, Poland
Vita Longa Sp z o o
Katowice, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, Poland
Centrum Medyczne Plejady
Krakow, Poland
Centrum Medyczne Promed
Krakow, Poland
Medrise Sp. z o.o.
Lublin, Poland
Allmedica
Nowy Targ, Poland
Medicus Zaniewski i Bilski
Olsztyn, Poland
Twoja Przychodnia
Opole, Poland
Pratia Poznan
Poznan, Poland
RiverMED
Poznan, Poland
Centrum Medyczne 'Medyk' Sp. z o.o. K.
Rzeszów, Poland
Endoskopia Sp z o.o.
Sopot, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland
Sonomed Sp. z o.o.
Szczecin, Poland
GASTROMED Sp. z o.o.
Torun, Poland
Clinical Best Solutions Warszawa
Warsaw, Poland
Medon Clinical Research
Warsaw, Poland
WSD MEDI Clinical Sp. z o. o.
Warsaw, Poland
Bodyclinic Sp. z o.o. sp. k
Warsaw, Poland
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Medical Network WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
Przychodnia Vistamed
Wroclaw, Poland
EMC Instytut Medyczny S A Penta Hospitals Przychodnie
Wroclaw, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek, Poland
ETG Zamosc
Zamość, Poland
Uls Braga - Hosp. Braga
Braga, Portugal
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, Portugal
Ulsam - Hosp. Santa Luzia
Viana do Castelo, Portugal
S C Delta Health Care S R L
Bucharest, Romania
Spitalul Clinic Colentina
Bucharest, Romania
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
Cluj-Napoca, Romania
Gastromed S R L
Constanța, Romania
Spitalul Clinic Judetean Sibiu
Sibiu, Romania
Inje University Haeundae Paik Hospital
Busan, South Korea
Yeungnam University Hospital
Daegu, South Korea
The Catholic University of Korea Daejeon St Mary's Hospital
Daejeon, South Korea
Seoul National University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, South Korea
Hosp. Clinic de Barcelona
Barcelona, Spain
Hosp. de Cabuenes
Cabueñes, Spain
Hosp. Arquitecto Marcide
Ferrol, Spain
Hosp. Galdakao-Usansolo
Galdakao, Spain
Hosp. Univ. de La Princesa
Madrid, Spain
Hosp. Univ. Infanta Leonor
Madrid, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
Hosp. Virgen Macarena
Seville, Spain
Hosp. Univ. I Politecni La Fe
Valencia, Spain
Hosp. Alvaro Cunqueiro
Vigo, Spain
Alingsas lasarett
Allingsas, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Linkoping University Hospital
Linköping, Sweden
Orebro universitetssjukhus
Örebro, Sweden
Ersta sjukhus
Stockholm, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, Sweden
Akademiska Sjukhuset
Uppsala, Sweden
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Gazi University Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye)
Antalya Training And Research Hospital
Antalya, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Mersin University Medical Faculty Hospital
Mersin, Turkey (Türkiye)
Fairfield General Hospital
Greater Manchester, United Kingdom
Whipps Cross University Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
St Georges University Hospitals NHS Foundation Trust
London, United Kingdom
Whiston Hospital
Rainhill, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom