Crohn's Disease Clinical Trials

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A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Status: Recruiting
Location: See all (353) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

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

• Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD

• Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \>=220 but \<=450 and either mean daily SF count \>=4, or mean daily AP score \>=2

• Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \>= 6 for participants with colonic or ileocolonic disease, and SES-CD \>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments

• A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-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 naïve to advanced therapies (advanced drug therapy \[ADT\]-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 CD- (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
Alliance Research Institute, LLC - Canoga Park
RECRUITING
Canoga Park
Southern California Research Center
RECRUITING
Coronado
Om Research, LLC 1
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
Florida
American Institute of Research
RECRUITING
Cutler Bay
Nature Coast Clinical Research
RECRUITING
Inverness
Green Leaf Clinical Trials
RECRUITING
Jacksonville
Florida Research Center Inc.
RECRUITING
Lakewood Rch
Sanchez Clinical Research, Inc
RECRUITING
Miami
GCP Clinical Research
RECRUITING
Tampa
Georgia
Children's Center for Digestive Health Care
RECRUITING
Atlanta
Gastroenterolgy Associates of Central GA
RECRUITING
Macon
Indiana
IU Health University Hospital
RECRUITING
Indianapolis
Kansas
Kansas Gastroenterology, LLC
RECRUITING
Wichita
Kentucky
Tri-State Gastroenterology Assoc
RECRUITING
Crestview Hills
Louisiana
Gastroenterology Clinic of Acadiana
RECRUITING
Lafayette
Delta Research Partners, LLC
RECRUITING
West Monroe
Maryland
Chevy Chase Clinical Research
RECRUITING
Chevy Chase
Woodholme Gastroenterology Associates
RECRUITING
Glen Burnie
Minnesota
Mayo Clinic 1
RECRUITING
Rochester
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Atrium Health
RECRUITING
Charlotte
New York
Westchester Putnam Gastroenterology
RECRUITING
Carmel
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
Baylor University Medical Center
RECRUITING
Dallas
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
Hospital Britanico de Buenos Aires
RECRUITING
Caba
Clinica Universitaria Reina Fabiola
RECRUITING
Córdoba
Hospital Privado de Cordoba
RECRUITING
Córdoba
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
Mater Hospital Brisbane
RECRUITING
South Brisbane
Belgium
CHU Saint-Pierre
RECRUITING
Brussels
Cliniques Universitaires Saint Luc
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
RECRUITING
Belo Horizonte
Unesp
RECRUITING
Botucatu
Chronos Clinica Medica Ltda
RECRUITING
Brasília
L2IP Instituto de Pesquisas Clinicas
RECRUITING
Brasília
CDC - Centro Digestivo de Curitiba
RECRUITING
Curitiba
ATO Terapias
RECRUITING
Fortaleza
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
RECRUITING
Jaú
Galileo Medical Research Ltda
RECRUITING
Juiz De Fora
Cliged
RECRUITING
Macaé
Liga Norte Riograndense Contra O Cancer
RECRUITING
Natal
Complexo Hospitalar de Niteroi
RECRUITING
Niterói
Hospital De Clinicas De Porto Alegre
RECRUITING
Porto Alegre
Hospital Ernesto Dornelles
RECRUITING
Porto Alegre
Hospital Moinhos de Vento
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Porto Alegre
Platano Centro De Pesquisa Clinica LTDA
RECRUITING
Recife
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
RECRUITING
Ribeirão Preto
Clinica Ibis Medicina Ltda
RECRUITING
Salvador
Pesquisare Saude
RECRUITING
Santo André
Irmandade da Santa Casa da Misericórdia de Santos
RECRUITING
Santos
Hospital de Base da Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
BR Trials
RECRUITING
São Paulo
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo (Hc-Fmusp)
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
CHUM - Centre hospitalier universitaire de Montreal
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
The second Xiangya Hospital of Central South University
RECRUITING
Changsha
Xiangya Hospital Central South University
RECRUITING
Changsha
Changzhou No 2 Peoples Hospital
RECRUITING
Changzhou
West China Hospital Si Chuan University
RECRUITING
Chengdu
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
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huizhou Central People's Hospital
RECRUITING
Huizhou
Jinhua municipal central hospital
RECRUITING
Jinhua
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 Guangxi Medical University
RECRUITING
Nanning
Ningbo medical center lihuili hospital
RECRUITING
Ningbo
Huashan Hospital Fudan University
RECRUITING
Shanghai
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University
RECRUITING
Shanghai
Shengjing Hospital Of China Medical University
RECRUITING
Shenyang
Shenzhen Hospital of Southern Medical University
RECRUITING
Shenzhen
Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The 2nd Affiliated Hospital & Yuying Children s Hospital Wenzhou Medical University
RECRUITING
Wenzhou
The Central Hospital of Wuhan
RECRUITING
Wuhan
Zhongshan Hospital, Xiamen University
RECRUITING
Xiamen
Northern Jiangsu Peoples Hospital
RECRUITING
Yangzhou
ZhuZhou Central Hospital
RECRUITING
Zhuzhou
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
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
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
DRK Kliniken Berlin Westend
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
Praxis fuer Gastroenterologie
RECRUITING
Lübeck
Staedtisches Klinikum Lueneburg
RECRUITING
Lüneburg
Universitaetsmedizin Rostock
RECRUITING
Rostock
Universitaetsklinikum Ulm
RECRUITING
Ulm
Greece
Evangelismos S A
RECRUITING
Athens
Hippokration Hospital
RECRUITING
Athens
Thoracic General Hospital Of Athens I Sotiria
RECRUITING
Athens
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon
RECRUITING
Nikaia
Tzanio General Hospital of Piraeus
RECRUITING
Piraeus
Ippokratio General Hospital Of Thessaloniki
RECRUITING
Thessaloniki
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
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
Asian Institute Of Gastroenterology
RECRUITING
Hyderabad
Yashoda Super Speciality Hospitals
RECRUITING
Hyderabad
S. R. Kalla Memorial General Hospital
RECRUITING
Jaipur
Yashoda Super Speciality Hospitals 1
RECRUITING
Secunderabad
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
RECRUITING
Surat
Israel
Ha'Emek Medical Center
RECRUITING
Afula
Assuta MC
RECRUITING
Ashdod
Shamir Medical Center Assaf Harofeh
RECRUITING
Be’er Ya‘aqov
Bnai Zion Medical Center
RECRUITING
Haifa
Rambam Medical Center
RECRUITING
Haifa
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
ARNAS G Brotzu
RECRUITING
Cagliari
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
RECRUITING
Milan
Ospedale San Raffaele di Milano
RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
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
Azienda Ospedaliera Città della Salute e della Scienza di Torino
RECRUITING
Torino
Japan
Juntendo University Hospital Urayasu
RECRUITING
Chiba
Fukui Prefectural Hospital
RECRUITING
Fukui-shi
Gamagori City Hospital
RECRUITING
Gamagōri
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Matsuda Hospital
RECRUITING
Hamamatsu
National Hospital Organization Mito Medical Center
RECRUITING
Higashiibaraki-gun
Hiroshima University Hospital
RECRUITING
Hiroshima
Kagoshima IBD Gastroenterology Clinic
RECRUITING
Kagoshima
Kanazawa University Hospital
RECRUITING
Kanazawa
Matsuda Pediatrics Digestion Clinic
RECRUITING
Kanazawa
Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa
Saitama Medical Center
RECRUITING
Kawagoe
Hospital of the University of Occupational and Environmental Health
RECRUITING
Kitakyushu
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Takano Hospital
RECRUITING
Kumamoto
Kurume University Hospital
RECRUITING
Kurume
Kyorin University Hospital
RECRUITING
Mitaka
Takagi Clinic
RECRUITING
Miyagi
Nagasaki University Hospital
RECRUITING
Nagasaki
Hyogo Medical University Hospital
RECRUITING
Nishinomiya Shi
Nakagami Hospital
RECRUITING
Okinawa
Kinshukai Infusion Clinic
COMPLETED
Osaka
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Saga University Hospital
RECRUITING
Saga
Toho University Sakura Medical Center
RECRUITING
Sakura
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
RECRUITING
Sapporo
Sapporo IBD Clinic
RECRUITING
Sapporo
Sapporo Tokushukai Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
National Center for Global Health and Medicine
RECRUITING
Shinjuku- Ku
Tokyo Yamate Medical Center
RECRUITING
Shinjuku-ku
National Hospital Organization Shizuoka Medical Center
RECRUITING
Sunto-gun
Malaysia
Hospital Sultanah Bahiyah
RECRUITING
Alor Star
Hospital Ampang
RECRUITING
Ampang
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Sultan Ahmad Shah Medical Centre IIUM
RECRUITING
Kuantan
Hospital Tuanku Jaafar
RECRUITING
Seremban
Netherlands
Vrije Universiteit Medisch Centrum
RECRUITING
Amsterdam
Maastricht UMC
RECRUITING
Maastricht
Radboud Umcn
RECRUITING
Nijmegen
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Poland
Centrum Medyczne Medis
RECRUITING
Bydgoszcz
NZOZ Centrum Medyczne KERmed
RECRUITING
Bydgoszcz
Osrodek Badan Klinicznych CLINSANTE S C
RECRUITING
Bydgoszcz
Centrum Medyczne Plejady
RECRUITING
Krakow
Centrum Medyczne Promed
RECRUITING
Krakow
Malopolskie Badania Kliniczne
RECRUITING
Krakow
Medrise Sp. z o.o.
RECRUITING
Lublin
Allmedica
RECRUITING
Nowy Targ
Medicus Zaniewski i Bilski
RECRUITING
Olsztyn
Twoja Przychodnia Opolskie Centrum Medyczne
RECRUITING
Opole
RiverMED
RECRUITING
Poznan
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp z o o
RECRUITING
Poznan
Centrum Medyczne Medyk
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
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
RECRUITING
Wroclaw
EMC Instytut Medyczny S A Penta Hospitals Przychodnie
RECRUITING
Wroclaw
Przychodnia Vistamed
RECRUITING
Wroclaw
ETG Zamosc
RECRUITING
Zamość
Portugal
Uls Braga - Hosp. Braga
RECRUITING
Braga
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
RECRUITING
Guimarães
Hosp. Lusiadas Lisboa
RECRUITING
Lisbon
Uls Santa Maria - Hosp. Santa Maria
RECRUITING
Lisbon
Uls Loures Odivelas - Hosp. Loures
RECRUITING
Loures
Uls Santo Antonio - Hosp. Santo Antonio
RECRUITING
Porto
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
Kyung Hee University Hospital
RECRUITING
Dongdaemun-gu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Kangbuk Samsung 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
Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
RECRUITING
Cluj-napoca
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
RECRUITING
Cluj-napoca
Gastromed S R L
RECRUITING
Constanța
Spitalul Clinic Judetean de Urgenta Sibiu
RECRUITING
Sibiu
Spain
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Hosp. de Cabuenes
RECRUITING
Gijón
Hosp. Univ. Dr. Josep Trueta
RECRUITING
Girona
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. de La Princesa
RECRUITING
Madrid
Hosp. Univ. Infanta Leonor
RECRUITING
Madrid
Hosp. Clinico Univ. de Santiago
RECRUITING
Santiago De Compostela
Hosp. Virgen Macarena
RECRUITING
Seville
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
Hosp. Univ. I Politecni La Fe
RECRUITING
Valencia
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
Inselspital Universitatsspital Bern
RECRUITING
Bern
Kantonsspital Sankt Gallen
RECRUITING
Sankt Gallen
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
Hacettepe University Hospital
RECRUITING
Ankara
Antalya Training And Research Hospital
RECRUITING
Antalya
Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Istanbul
Koc University, School of Medicine, Koc University Hospital
RECRUITING
Istanbul
Ege Universitesi Tip Fakultesi
RECRUITING
Izmir
Izmir Sehir Hastanesi
RECRUITING
Izmir
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
Mersin University Medical Faculty
RECRUITING
Mersin
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
Glasgow Royal Infirmary
RECRUITING
Glasgow
Fairfield General Hospital
RECRUITING
Greater Manchester
Guy's Hospital
RECRUITING
London
St Georges University Hospital NHS Foundation Trust
RECRUITING
London
Whipps Cross University Hospital
RECRUITING
London
Whiston Hospital
RECRUITING
Rainhill
Stepping Hill Hospital
RECRUITING
Stockport
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2032-10-06
Participants
Target number of participants: 1092
Treatments
Experimental: Induction Study 1: Icotrokinra Dose 1
Participants will receive Icotrokinra dose 1 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Experimental: Induction Study 1: Icotrokinra Dose 2
Participants will receive Icotrokinra dose 2 in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Placebo_comparator: Induction Study 1: Placebo
Participants will receive matching placebo in Induction Study 1 up to Week 12. Subsequent treatment will be determined by the participant's response status at Week 12.
Experimental: Induction Study 2: Icotrokinra
Participants will receive Icotrokinra at the dose regimen determined in Induction Study 1 up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Placebo_comparator: Induction Study 2: Placebo
Participants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Experimental: Maintenance Study: Icotrokinra Dose 1
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 1. Participants receiving Icotrokinra Dose 1 and meeting criteria for loss of response during the Maintenance Study will be eligibile for a single blinded dose adjustment to Icotrokinra Dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in long-term extension (LTE).
Experimental: Maintenance Study: Icotrokinra Dose 2
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 of the induction study will be randomized to receive icotrokinra maintenance dose 2. Participants who were non-responders at Week 12 of the induction studies will also receive icotrokinra maintenance dose 2 but will not be randomized. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Placebo_comparator: Maintenance Study: Placebo
Participants who were receiving icotrokinra in either induction studies 1 or 2 and were in response at Week 12 will be randomized to receive placebo. Participants receiving placebo in induction studies 1 or 2 and in response at Week 12 of the induction study will continue to receive placebo during maintenance on non-randomized basis. Placebo non-responders from induction study will receive icotrokinra maintenance dose 2 on a non-randomized basis and will be assessed for response at Week 12.~Participants receiving placebo and meeting criteria for loss of response during the Maintenance Study will be eligible for a single blinded dose adjustment to icotrokinra dose 2. After completion of the Maintenance Study through Week 40, eligible participants can participate in LTE.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov