Ulcerative Colitis Clinical Trials

Find Ulcerative Colitis Clinical Trials Near You

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

Status: Recruiting
Location: See all (382) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC

• Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy

• An endoscopy subscore greater than or equal to (\>=) 2 as obtained during central review of the screening video endoscopy

• Adolescent Participants: body weight must be \>= 40 kilograms (kg) at baseline (Week I-0)

• Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \[β-hCG\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests

• Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of UC (ADT-inadequate responder \[IR\]) as defined in the protocol

Locations
United States
Arizona
AZ Gastro Care
RECRUITING
Chandler
Research Solutions of Arizona
RECRUITING
Litchfield Park
Mayo Clinic
RECRUITING
Scottsdale
California
Clinnova Research
RECRUITING
Anaheim
Southern California Research Center
RECRUITING
Coronado
Om Research LLC
RECRUITING
Lancaster
GastroIntestinal Bioscience
RECRUITING
Los Angeles
TLC Clinical Research Inc
RECRUITING
Los Angeles
Om Research LLC 2
RECRUITING
Oxnard
Clinical Applications Laboratories, Inc
RECRUITING
San Diego
Medical Associates Research Group, Inc.
RECRUITING
San Diego
University of California San Francisco
RECRUITING
San Francisco
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Connecticut
Nuvance Health Danbury Hospital
COMPLETED
Danbury
Connecticut Children's Medical Center
RECRUITING
Hartford
Florida
American Institute of Research
RECRUITING
Cutler Bay
Nature Coast Clinical Research
RECRUITING
Inverness
Florida Research Institute
RECRUITING
Lakewood Rch
GCP Clinical Research
RECRUITING
Tampa
Georgia
Atlanta Gastroenterology Associates
RECRUITING
Atlanta
Children's Center for Digestive Health Care
RECRUITING
Atlanta
Gastroenterolgy Associates of Central GA
RECRUITING
Macon
Kansas
Cotton O'Neil Digestive Health Center
RECRUITING
Topeka
Kentucky
Tri-State Gastroenterology Assoc
RECRUITING
Crestview Hills
Louisiana
Delta Research Partners, LLC
RECRUITING
West Monroe
Maryland
Chevy Chase Clinical Research
RECRUITING
Chevy Chase
Woodholme Gastroenterology Associates
RECRUITING
Glen Burnie
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Atrium Health
RECRUITING
Charlotte
New York
Westchester Putnam Gastroenterology
RECRUITING
Carmel
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Inflammatory Bowel Disease Center at NYU Langone
RECRUITING
New York
Lenox Hill Hospital
RECRUITING
New York
Manhattan Clinical Research LLC
RECRUITING
New York
New York Gastroenterology Associates
RECRUITING
New York
Weill Cornell Medical College
RECRUITING
New York
Ohio
Gastro Intestinal Research Institute of Northern Ohio LLC
SUSPENDED
Westlake
Oklahoma
Digestive Disease Specialists Inc
RECRUITING
Oklahoma City
Oregon
The Oregon Clinic
RECRUITING
Portland
Pennsylvania
Susquehanna Research Group
RECRUITING
Harrisburg
Penn State Milton S Hershey Medical Ctr
RECRUITING
Hershey
Jefferson Digestive Health Institute
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Rhode Island
University Gastroenterology
RECRUITING
Providence
South Carolina
Digestive Disease Associates
RECRUITING
Rock Hill
Texas
The University of Texas at Austin
RECRUITING
Austin
DFW Clinical Trials
RECRUITING
Carrollton
Victorium Clinical Research
RECRUITING
Houston
Southern Star Research Institute, LLC
RECRUITING
San Antonio
GI Alliance Southlake
RECRUITING
Southlake
Tyler Research Institute, LLC
RECRUITING
Tyler
Virginia
Gastroenterology Associates of Tidewater
RECRUITING
Chesapeake
Blue Ridge Medical Research
RECRUITING
Lynchburg
Washington
GI Alliance Tacoma
RECRUITING
Tacoma
Other Locations
Argentina
GEDYT
RECRUITING
Aai
Cer Instituto Medico
RECRUITING
Buenos Aires
Hospital Britanico de Buenos Aires
RECRUITING
Buenos Aires
Kynet Recoleta
RECRUITING
Buenos Aires
CIPREC
RECRUITING
Caba
Instituto de Investigaciones Clinicas T y T
RECRUITING
Caba
Clinica Universitaria Reina Fabiola
RECRUITING
Córdoba
Hospital Privado Centro Medico de Cordoba
RECRUITING
Córdoba
Hospital Sor Maria Ludovica de La Plata
RECRUITING
La Plata
Sanatorio Maipu
RECRUITING
Maipu
HIGEA
RECRUITING
Mendoza
Australia
Monash Medical Centre
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Fiona Stanley Hospital
RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
New Lambton Heights
Royal Melbourne Hospital
RECRUITING
Parkville
Mater Hospital Brisbane
RECRUITING
South Brisbane
Belgium
CHU Saint-Pierre
RECRUITING
Brussels
Cliniques Universitaires Saint Luc
RECRUITING
Brussels
Huderf
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
AZ St. Lucas
RECRUITING
Ghent
Ghent University Hospital
RECRUITING
Ghent
Universitair Ziekenhuis Leuven
RECRUITING
Leuven
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
RECRUITING
Liège
AZ Oostende
RECRUITING
Ostend
CHwapi
RECRUITING
Tournai
Brazil
Hospital das Clinicas do HC/UFMG
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Belo Horizonte
Unesp
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Botucatu
CDC - Centro Digestivo de Curitiba
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Curitiba
Hospital Pequeno Principe
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Curitiba
ATO Terapias
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Fortaleza
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
RECRUITING
Jaú
Liga Norte Riograndense Contra O Cancer
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Natal
Complexo Hospitalar de Niteroi
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Niterói
Hospital De Clinicas De Porto Alegre
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Porto Alegre
Hospital Ernesto Dornelles
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Porto Alegre
Hospital Moinhos de Vento
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Porto Alegre
Platano Centro De Pesquisa Clinica LTDA
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Recife
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING
Ribeirão Preto
Pesquisare Saude
RECRUITING
Santo André
BR Trials
RECRUITING
São Paulo
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
Instituto D Or de Pesquisa e Ensino
RECRUITING
São Paulo
Solare Trials
RECRUITING
São Paulo
INTEGRAL Pesquisa e Ensino
RECRUITING
Votuporanga
Canada
Barrie GI Associates
RECRUITING
Barrie
South Edmonton Gastroenterology Research Clinic
RECRUITING
Edmonton
Viable Clinical Research
RECRUITING
Kentville
London Digestive Disease Institute
RECRUITING
London
West GTA Research Inc
RECRUITING
Mississauga
CHUM - Centre hospitalier universitaire de Montreal
RECRUITING
Montreal
Clinique IMD
RECRUITING
Montreal
ABP Research Services Corp.
RECRUITING
Oakville
Toronto Immune and Digestive Health Institute Inc
RECRUITING
Toronto
GIRI Gastrointestinal Research Institute
RECRUITING
Vancouver
China
Capital Medical University, Beijing Friendship Hospital
RECRUITING
Beijing
China Japan Friendship Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
West China School of Medicine/West China Hospital, Sichuan University
RECRUITING
Cheng Du Shi
Chongqing General Hospital
RECRUITING
Chongqing
The First People's Hospital of Foshan
RECRUITING
Foshan
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
The First Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Sixth Affiliated Hospital Sun Yat sen University
RECRUITING
Guangzhou
Affiliated Hospital of Hainan Medical University
RECRUITING
Haikou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Heilongjiang Provincial Hospital
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huizhou Central People's Hospital
RECRUITING
Huizhou
Lanzhou University Second Hospital
RECRUITING
Lanzhou
The first affiliated hospital of Henan University of science and technology
RECRUITING
Luoyang
The affiliated hospital of Southwest Medical University
RECRUITING
Luzhou
Jiangsu Province Hospital of Traditional Chinese Medicine
RECRUITING
Nanjing
Zhongda Hospital Southeast University
RECRUITING
Nanjing
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Ruijin Hospital Shanghai Jiao Tong University
RECRUITING
Shanghai
Shengjing Hospital Of China Medical University
RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
The Second Affiliatted Hospital of Soochow University
RECRUITING
Suzhou
Taian City Central Hospital
RECRUITING
Taian
Meihekou Central Hospital
RECRUITING
Tonghua
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The Central Hospital of Wuhan
RECRUITING
Wuhan
Wuxi People s Hospital
RECRUITING
Wuxi
Northern Jiangsu Peoples Hospital
RECRUITING
Yangzhou
Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
France
Centre Hospitalier de la Cote Basque
RECRUITING
Bayonne
CHU de Clermont Ferrand - Site Estaing
RECRUITING
Clermont-ferrand
APHP - Hopital Henri Mondor
RECRUITING
Créteil
Institut Prive MICI Clinique des Cedres
RECRUITING
Échirolles
CHU de Lille Hopital Claude Huriez
RECRUITING
Lille
Hôpital Jeanne de FLANDRE, CHRU LILLE
RECRUITING
Lille
CHU de Limoges Hopital Dupuytren
RECRUITING
Limoges
GHI Le Raincy Montfermeil
RECRUITING
Montfermeil
CHU de Montpellier Hopital Saint Eloi
RECRUITING
Montpellier
Jules Verne Clinic
RECRUITING
Nantes
CHU de Nice Hopital de l Archet
RECRUITING
Nice
Hopital Saint-Antoine
RECRUITING
Paris
CHU de Bordeaux - Hospital Haut-Leveque
RECRUITING
Pessac
Hospices Civils de Lyon CHU Lyon Sud
RECRUITING
Pierre-bénite
CHU Saint Etienne Hopital Nord
RECRUITING
Saint-priest-en-jarez
CHU Toulouse - Hopital de Rangueil
RECRUITING
Toulouse
CHRU de Nancy - Hopitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Germany
Universitaetsklinikum der RWTH Aachen
RECRUITING
Aachen
Krankenhaus Waldfriede Mitte
RECRUITING
Berlin
Medizinisches Versorgungszentrum (MVZ) Dachau
RECRUITING
Dachau
Universitaetsklinik Erlangen
RECRUITING
Erlangen
BSF Studiengesellschaft
RECRUITING
Halle
Medizinische Hochschule Hannover
RECRUITING
Hanover
Praxisgemeinschaft Jerichow
RECRUITING
Jerichow
Universitatsklinikum Schleswig Holstein Kiel
RECRUITING
Kiel
Eugastro GmbH
RECRUITING
Leipzig
Staedtisches Klinikum Lueneburg
RECRUITING
Lüneburg
Dr. von Haunersches Kinderspital
RECRUITING
München
Universitaetsmedizin Rostock
RECRUITING
Rostock
Universitaetsklinikum Ulm
RECRUITING
Ulm
HELIOS Klinikum Wuppertal GmbH
RECRUITING
Wuppertal
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens
Evangelismos S A
RECRUITING
Athens
Hippokration Hospital
RECRUITING
Athens
Thoracic General Hospital Of Athens I Sotiria
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon
RECRUITING
Nikaia
Geniko Nosokomeio Peiraia Tzaneio
RECRUITING
Piraeus
Theageneio Cancer Hospital
RECRUITING
Thessaloniki
Hungary
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
RECRUITING
Békéscsaba
Obudai Egeszsegugyi Centrum Kft
RECRUITING
Budapest
Pannónia Magánorvosi Centrum Kft
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Semmelweis Egyetem 1
RECRUITING
Budapest
Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
RECRUITING
Debrecen
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
RECRUITING
Debrecen
Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz
RECRUITING
Nyíregyháza
Szegedi Tudományegyetem Áok Szent-Györgyi Albert Klinikai Központ
RECRUITING
Szeged
Clinfan Ltd. SMO
RECRUITING
Szekszárd
Szent Borbala Hospital Tatabanya
RECRUITING
Tatabánya
India
Mazumdar Shaw Medical Centre - Narayana Hrudayalaya Limited
RECRUITING
Bangalore
Aster CMI Hospital
RECRUITING
Bengaluru
SUM Ultimate Medicare
RECRUITING
Bhubaneswar
Lisie Hospital
RECRUITING
Ernākulam
Fortis Memorial Research Institute
RECRUITING
Gurugram
Asian Institute Of Gastroenterology
RECRUITING
Hyderabad
Yashoda Super Speciality Hospitals 1
RECRUITING
Hyderabad
S. R. Kalla Memorial General Hospital
RECRUITING
Jaipur
Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines
RECRUITING
Ludhiana
Fortis Hospital
RECRUITING
Ludhiana
P D Hinduja National Hospital and Medical Research Center
RECRUITING
Mumbai
All India Institute of Medical Sciences
RECRUITING
New Delhi
GB Pant Institute of Post Graduate Medical Education & Research
RECRUITING
New Delhi
Indraprastha Apollo Hospital
RECRUITING
New Delhi
Sir Ganga Ram Hospital
RECRUITING
New Delhi
All India Institute of Medical Sciences
RECRUITING
Patna
Yashoda Super Speciality Hospitals
RECRUITING
Secunderabad
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
RECRUITING
Surat
Israel
Haemek Medical Center
RECRUITING
Afula
Assuta MC
RECRUITING
Ashdod
Shamir Medical Center Assaf Harofeh
RECRUITING
Be’er Ya‘aqov
Shamir Medical Center Assaf Harofeh 1
RECRUITING
Be’er Ya‘aqov
Bnai Zion Medical Center
RECRUITING
Haifa
Rambam Health Care Campus
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center 1
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Schneider Children's Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sheba Medical Center 1
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Tel Aviv Sourasky Medical Center 1
RECRUITING
Tel Aviv
Italy
A O U Sant Orsola Malpighi
RECRUITING
Bologna
Azienda Ospedaliero Universitaria Careggi
RECRUITING
Florence
ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi
RECRUITING
Milan
Ospedale San Raffaele di Milano
RECRUITING
Milan
Ospedale Sacro Cuore Negrar-Verona
RECRUITING
Negrar-verona
Azienda Ospedaliera San Camillo-Forlanini
RECRUITING
Roma
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Casa Sollievo Della Sofferenza IRCCS
RECRUITING
San Giovanni Rotondo
Japan
Juntendo University Hospital Urayasu
RECRUITING
Chiba
Ginza central clinic
RECRUITING
Chūōku
Sai Gastroenterology Proctology
RECRUITING
Fujiidera-shi
Fukui Prefectural Hospital
RECRUITING
Fukui-shi
Saiseikai Fukuoka General Hospital
RECRUITING
Fukuoka
Gamagori City Hospital
RECRUITING
Gamagōri
Matsuda Hospital
RECRUITING
Hamamatsu
National Hospital Organization Mito Medical Center
RECRUITING
Higashiibaraki-gun
Hirosaki General Medical Center
RECRUITING
Hirosaki
Kagoshima IBD Gastroenterology Clinic
RECRUITING
Kagoshima
Kanazawa University Hospital
RECRUITING
Kanazawa
National Hospital Organization Kanazawa Medical Center
RECRUITING
Kanazawa
Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa
Hospital of the University of Occupational and Environmental Health
RECRUITING
Kitakyushu
Aoyama Naika Clinic
RECRUITING
Kobe
Kobe University Hospital
RECRUITING
Kobe
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Kumamoto University Hospital
RECRUITING
Kumamoto
Takano Hospital
RECRUITING
Kumamoto
Kurume University Hospital
RECRUITING
Kurume
Kyorin University Hospital
RECRUITING
Mitaka
Takagi Clinic
RECRUITING
Miyagi
Hyogo Medical University Hospital
RECRUITING
Nishinomiya Shi
Oita Red Cross Hospital
RECRUITING
Ōita
Nakagami Hospital
RECRUITING
Okinawa
Japanese Red Cross Osaka Hospital
RECRUITING
Osaka
Kinshukai Infusion Clinic
COMPLETED
Osaka
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
RECRUITING
Sapporo
Sapporo Tokushukai Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
Tokyo Metropolitan Bokutoh Hospital
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Sumida Ku
National Hospital Organization Shizuoka Medical Center
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Sunto-gun
Yokohama City University Medical Center
RECRUITING
Yokohama
Malaysia
Hospital Sultanah Bahiyah
RECRUITING
Alor Star
Hospital Ampang
RECRUITING
Ampang
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Sultan Idris Shah Hospital
RECRUITING
Kajang
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
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Kuala Lumpur
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Netherlands
Vrije Universiteit Medisch Centrum
RECRUITING
Amsterdam
Maastricht UMC
RECRUITING
Maastricht
Radboud Umcn
RECRUITING
Nijmegen
Poland
Centrum Medyczne Medis ManerMed Sp Z O O
RECRUITING
Bydgoszcz
NZOZ Centrum Medyczne KERmed
RECRUITING
Bydgoszcz
Osrodek Badan Klinicznych CLINSANTE S C
RECRUITING
Bydgoszcz
Vita Longa Sp z o o
RECRUITING
Katowice
Centrum Medyczne Plejady
RECRUITING
Krakow
Malopolskie Badania Kliniczne Sp z o o
RECRUITING
Krakow
Promed P. Lach R. Glowacki Sp.j. Centrum Medyczne Promed
RECRUITING
Krakow
Medrise Sp. z o.o.
RECRUITING
Lublin
Allmedica
RECRUITING
Nowy Targ
Medicus Zaniewski i Bilski
RECRUITING
Olsztyn
Twoja Przychodnia
RECRUITING
Opole
RiverMED
RECRUITING
Poznan
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp z o o
RECRUITING
Poznan
Centrum Medyczne 'Medyk' Sp. z o.o. K.
RECRUITING
Rzeszów
Endoskopia Sp z o.o.
RECRUITING
Sopot
Sonomed Sp. z o.o.
RECRUITING
Szczecin
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
GASTROMED Sp. z o.o.
RECRUITING
Torun
Bodyclinic Sp. z o.o. sp. k
RECRUITING
Warsaw
Clinical Best Solutions Warszawa
RECRUITING
Warsaw
Instytut Pomnik Centrum Zdrowia Dziecka
RECRUITING
Warsaw
Medical Network WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Medon Clinical Research
RECRUITING
Warsaw
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
RECRUITING
Warsaw
WSD MEDI Clinical Sp. z o. o.
RECRUITING
Warsaw
Centrum Medyczne Oporow
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Wroclaw
EMC Instytut Medyczny S A Penta Hospitals Przychodnie
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Wroclaw
Vistamed & Vertigo Sp Z O O
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Wroclaw
ETG Zamosc
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Zamość
Portugal
Uls Braga - Hosp. Braga
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Braga
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
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Guimarães
Uls Santa Maria - Hosp. Santa Maria
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Lisbon
Uls Loures Odivelas - Hosp. Loures
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Loures
Uls Santo Antonio - Hosp. Santo Antonio
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Porto
Ulsam - Hosp. Santa Luzia
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Viana Do Castelo
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Yeungnam University Hospital
RECRUITING
Daegu
The Catholic University of Korea Daejeon St Mary's Hospital
RECRUITING
Daejeon
Asan Medical Center
RECRUITING
Seoul
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
The Catholic university of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Romania
S C Delta Health Care S R L
RECRUITING
Bucharest
Spitalul Clinic Colentina
RECRUITING
Bucharest
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
RECRUITING
Cluj-napoca
Gastromed S R L
RECRUITING
Constanța
Spitalul Clinic Judetean de Urgenta Craiova
RECRUITING
Craiova
Spitalul Clinic Judetean Sibiu
RECRUITING
Sibiu
Spain
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Hosp. Sant Joan de Deu
RECRUITING
Barcelona
Hosp. Arquitecto Marcide
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Ferrol
Hosp. Galdakao-Usansolo
RECRUITING
Galdakao
Hosp. de Cabuenes
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Gijón
Hosp. Univ. Dr. Josep Trueta
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Girona
Hosp. Univ. de La Princesa
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Madrid
Hosp. Univ. Infanta Leonor
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Madrid
Hosp. Clinico Univ. de Santiago
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Santiago De Compostela
Hosp. Virgen Macarena
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Seville
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
Hosp. Alvaro Cunqueiro
RECRUITING
Vigo
Sweden
Alingsas lasarett
RECRUITING
Allingsas
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Linkoping University Hospital
RECRUITING
Linköping
Orebro universitetssjukhus
RECRUITING
Örebro
Ersta sjukhus
RECRUITING
Stockholm
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Akademiska Sjukhuset
RECRUITING
Uppsala
Switzerland
Department of Visceral Surgery and Medicine
RECRUITING
Bern
HOCH Health Ostschweiz Kantonsspital St.Gallen
RECRUITING
Sankt Gallen
University Hospital Zurich
RECRUITING
Zurich
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Mackay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital
RECRUITING
Taoyuan
Turkey
Ankara Bilkent Sehir Hastanesi
RECRUITING
Ankara
Gazi University Hospital
RECRUITING
Ankara
Gazi University Hospital 1
RECRUITING
Ankara
Hacettepe University Medical Faculty
RECRUITING
Ankara
Antalya Training And Research Hospital
RECRUITING
Antalya
Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Istanbul
Marmara University Istanbul Pendik Education and Research Hospital
RECRUITING
Istanbul
Marmara University Istanbul Pendik Education and Research Hospital 1
RECRUITING
Istanbul
Ege University Medical Faculty
RECRUITING
Izmir
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
Mersin University Medical Faculty Hospital
RECRUITING
Mersin
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Royal Hospital for Children and Young People
RECRUITING
Edinburgh
Fairfield General Hospital
RECRUITING
Greater Manchester
Kings College Hospital
RECRUITING
London
St Georges University Hospitals NHS Foundation Trust
RECRUITING
London
Whipps Cross University Hospital
RECRUITING
London
Whiston Hospital
RECRUITING
Rainhill
Sheffield Children's Hospital
RECRUITING
Sheffield
Stepping Hill Hospital
RECRUITING
Stockport
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2032-01-13
Participants
Target number of participants: 882
Treatments
Experimental: Double-blind (DB) Induction Study: Icotrokinra
Adult participants will be randomized to receive icotrokinra daily, orally starting at induction Week 0 (Week I-0). At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Placebo_comparator: DB Induction Study: Placebo
Adult participants will be randomized to receive placebo daily, orally starting at Week I-0. At Week I-12, all participants will be evaluated for clinical response and will enter the Maintenance study.
Experimental: DB Maintenance Study: Icotrokinra
Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive icotrokinra daily, orally starting at maintenance Week 0 (Week M-0) through Week M-40. Participants who are clinical nonresponders to icotrokinra or placebo will also enter the Maintenance study directly and receive icotrokinra daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a long-term extension (LTE).
Placebo_comparator: DB Maintenance Study: Placebo
Adult participants who are in clinical response to icotrokinra at the end of the Induction study will enter the Maintenance study and be randomized to receive placebo daily, orally starting at Week M-0 through Week M-40. Participants who are clinical responders to placebo will also enter the Maintenance study directly and continue to receive placebo daily. After completion of the Maintenance study through Week M-40, eligible participants can participate in a LTE.
Experimental: Open-label (OL) Induction Phase: Icotrokinra
Adolescent participants will enter the Induction phase and receive icotrokinra daily, orally. At Week I-12 all participants will be evaluated for clinical response and will enter the Maintenance phase.
Experimental: OL Maintenance Phase: Icotrokinra
Adolescent participants who are in clinical response to icotrokinra will enter the Maintenance phase at Week M-0 and continue to receive icotrokinra daily, orally up to Week M-40. Participants who are nonresponders to icotrokinra will also enter the Maintenance phase to receive icotrokinra daily. After completion of the Maintenance phase through Week M-40, eligible participants can participate in a LTE.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov