A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
ICONIC-UC
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
2 other identifiers
interventional
882
28 countries
367
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2025
Longer than P75 for phase_3
367 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2025
CompletedFirst Posted
Study publicly available on registry
September 29, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 13, 2032
April 13, 2026
April 1, 2026
2.3 years
September 22, 2025
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Double-blind (DB) Induction Study: Percentage of Adult Participants in Clinical Remission at Week I-12
Percentage of adult participants in clinical remission at Week I-12 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
At Week I-12
DB Maintenance Study: Percentage of Adult Participants in Clinical Remission at Week M-40
Percentage of adult participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
At Week M-40
Open-Label (OL) Maintenance Phase: Percentage of Adolescent Participants in Clinical Remission at Week M-40
Percentage of adolescent participants in clinical remission at Week M-40 will be reported. Clinical remission is defined as stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
At Week M-40
Secondary Outcomes (44)
DB Induction Study: Percentage of Adult Participants in Clinical Response at Week I-12
At Week I-12
DB Induction Study: Percentage of Adult Participants with Endoscopic Improvement at Week I-12
At Week I-12
DB Induction Study: Percentage of Adult Participants in Symptomatic Remission at Week I-12
At Week I-12
DB Induction Study: Percentage of Adult Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week I-12
At Week I-12
DB Induction Study: Percentage of Adult Participants with Histologic-Endoscopic Mucosal Improvement (HEMI) at Week I-12
At Week I-12
- +39 more secondary outcomes
Study Arms (6)
Double-blind (DB) Induction Study: Icotrokinra
EXPERIMENTALAdult 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.
DB Induction Study: Placebo
PLACEBO COMPARATORAdult 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.
DB Maintenance Study: Icotrokinra
EXPERIMENTALAdult 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).
DB Maintenance Study: Placebo
PLACEBO COMPARATORAdult 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.
Open-label (OL) Induction Phase: Icotrokinra
EXPERIMENTALAdolescent 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.
OL Maintenance Phase: Icotrokinra
EXPERIMENTALAdolescent 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.
Interventions
Icotrokinra tablet will be administered orally.
Placebo tablet will be administered orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study
- Presence of a stoma
- Presence or history of a fistula
- Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline
- History of extensive colonic resection (that is, less than \[\<\] 30 centimeter \[cm\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (367)
AZ Gastro Care
Chandler, Arizona, 85206, United States
Research Solutions of Arizona
Litchfield Park, Arizona, 85340, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Clinnova Research
Anaheim, California, 92805, United States
Southern California Research Center
Coronado, California, 92118, United States
Om Research LLC
Lancaster, California, 93534, United States
TLC Clinical Research Inc
Los Angeles, California, 90048, United States
GastroIntestinal Bioscience
Los Angeles, California, 90067, United States
Om Research LLC 2
Oxnard, California, 93030, United States
Clinical Applications Laboratories, Inc
San Diego, California, 92103, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Nuvance Health Danbury Hospital
Danbury, Connecticut, 06810, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
American Institute of Research
Cutler Bay, Florida, 33157, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, 30342, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
Delta Research Partners, LLC
West Monroe, Louisiana, 71291, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, 21061, United States
Westchester Putnam Gastroenterology
Carmel, New York, 10512, United States
Manhattan Clinical Research LLC
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Lenox Hill Hospital
New York, New York, 10075, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
Gastro Intestinal Research Institute of Northern Ohio LLC
Westlake, Ohio, 44145, United States
Digestive Disease Specialists Inc
Oklahoma City, Oklahoma, 73114, United States
The Oregon Clinic
Portland, Oregon, 97220-9428, United States
Susquehanna Research Group
Harrisburg, Pennsylvania, 17110-3673, United States
Penn State Milton S Hershey Medical Ctr
Hershey, Pennsylvania, 17033, United States
Jefferson Digestive Health Institute
Philadelphia, Pennsylvania, 19107, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Digestive Disease Associates
Rock Hill, South Carolina, 29732, United States
The University of Texas at Austin
Austin, Texas, 78712, United States
DFW Clinical Trials
Carrollton, Texas, 75010, United States
Victorium Clinical Research
Houston, Texas, 77024, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
GEDYT
AAI, C1425BGC, Argentina
Cer Instituto Medico
Buenos Aires, 1878, Argentina
Kynet Recoleta
Buenos Aires, C1119, Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, C1280AEB, Argentina
CIPREC
CABA, C1061AAS, Argentina
Instituto de Investigaciones Clinicas T y T
Caba, C1405, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, X5004FHP, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Hospital Sor Maria Ludovica de La Plata
La Plata, B1904, Argentina
Sanatorio Maipu
Maipú, M5515, Argentina
HIGEA
Mendoza, M5500, Argentina
Monash Medical Centre
Clayton, 3168, Australia
Concord Repatriation General Hospital
Concord, 2139, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
John Hunter Hospital
New Lambton Heights, 2305, Australia
Royal Melbourne Hospital
Parkville, 3050, Australia
Mater Hospital Brisbane
South Brisbane, 4101, Australia
CHU Saint-Pierre
Brussels, 1000, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
AZ St. Lucas
Ghent, 9000, Belgium
Ghent University Hospital
Ghent, 9000, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
AZ Oostende
Ostend, 8400, Belgium
CHwapi
Tournai, 7500, Belgium
Hospital das Clinicas do HC/UFMG
Belo Horizonte, 30130 100, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, 80430 180, Brazil
ATO Terapias
Fortaleza, 60140 025, Brazil
CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda
Jaú, 17201 130, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000, Brazil
Platano Centro De Pesquisa Clinica LTDA
Recife, 52011 200, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
Ribeirão Preto, 14051140, Brazil
Hospital Israelita Albert Einstein
São Paulo, 05651 900, Brazil
INTEGRAL Pesquisa e Ensino
Votuporanga, 15500-269, Brazil
South Edmonton Gastroenterology Research Clinic
Edmonton, Alberta, Code: T6K 4B2, Canada
GIRI Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Viable Clinical Research
Kentville, Nova Scotia, B4N 0A3, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
London Digestive Disease Institute
London, Ontario, N6K 1M6, Canada
West GTA Research Inc
Mississauga, Ontario, L5M 2S4, Canada
ABP Research Services Corp.
Oakville, Ontario, L6L 5L7, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, M6A 3B4, Canada
CHUM - Centre hospitalier universitaire de Montreal
Montreal, Quebec, H2X 0C1, Canada
Clinique IMD
Montreal, Quebec, H3H1E8, Canada
China Japan Friendship Hospital
Beijing, 100029, China
Capital Medical University, Beijing Friendship Hospital
Beijing, 100050, China
Changzhou No 2 Peoples Hospital
Changzhou, 213003, China
West China School of Medicine/West China Hospital, Sichuan University
Cheng Du Shi, 610041, China
Chongqing General Hospital
Chongqing, 400014, China
The First People's Hospital of Foshan
Foshan, 528010, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350004, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510080, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510655, China
Affiliated Hospital of Hainan Medical University
Haikou, 570102, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310000, China
Heilongjiang Provincial Hospital
Harbin, 150036, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huizhou Central People's Hospital
Huizhou, 516001, China
Lanzhou University Second Hospital
Lanzhou, 730030, China
The first affiliated hospital of Henan University of science and technology
Luoyang, 471000, China
The affiliated hospital of Southwest Medical University
Luzhou, 646000, China
Zhongda Hospital Southeast University
Nanjing, 210000, China
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, 210004, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315211, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, 200025, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
The Second Hospital of Hebei Medical University
Shijiazhuang, 050090, China
The Second Affiliatted Hospital of Soochow University
Suzhou, 215000, China
Taian City Central Hospital
Taian, 271000, China
Meihekou Central Hospital
Tonghua, 135022, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Wuxi People s Hospital
Wuxi, 214023, China
Northern Jiangsu Peoples Hospital
Yangzhou, 225001, China
Affiliated Hospital of Zunyi Medical University
Zunyi, 563099, China
Fakultni nemocnice Brno
Brno, 62500, Czechia
Vojenska nemocnice Brno
Brno, 636 00, Czechia
Nemocnice Ceske Budejovice
České Budějovice, 370 01, Czechia
Centrum gastroenterologie a hepatologie s.r.o.
Kladno, 27280, Czechia
PreventaMed, s.r.o.
Olomouc, 77900, Czechia
Gastromedic, Ltd.
Pardubice, 530 03, Czechia
AXON Clinical s.r.o.
Prague, 140 00, Czechia
Fakultni Thomayerova nemocnice
Prague, 140 59, Czechia
Clinoxus s r o
Prague, 14000, Czechia
Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze
Praha 1- Mala Strana, 118 33, Czechia
MUDr. Michal Konecny, Ph.D. s.r.o.
Přerov, 750 02, Czechia
Centre Hospitalier de la Cote Basque
Bayonne, 64109, France
CHU de Clermont Ferrand - Site Estaing
Clermont-Ferrand, 63100, France
APHP - Hopital Henri Mondor
Créteil, 94000, France
Institut Prive MICI Clinique des Cedres
Échirolles, 38130, France
CHU de Lille Hopital Claude Huriez
Lille, 59037, France
Hôpital Jeanne de FLANDRE, CHRU LILLE
Lille, 59037, France
CHU de Limoges Hopital Dupuytren
Limoges, 87042, France
GHI Le Raincy Montfermeil
Montfermeil, 93370, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34090, France
Jules Verne Clinic
Nantes, 44300, France
CHU de Nice Hopital de l Archet
Nice, 06200, France
Hopital Saint-Antoine
Paris, 75012, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac, 33604, France
Hospices Civils de Lyon CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270, France
CHU Toulouse - Hopital de Rangueil
Toulouse, 31400, France
CHRU de Nancy - Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
Universitaetsklinikum der RWTH Aachen
Aachen, 52074, Germany
Krankenhaus Waldfriede Mitte
Berlin, 14163, Germany
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, 85221, Germany
Universitaetsklinik Erlangen
Erlangen, 91054, Germany
BSF Studiengesellschaft
Halle, 06108, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Praxisgemeinschaft Jerichow
Jerichow, 39319, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Dr. von Haunersches Kinderspital
München, 80337, Germany
Universitaetsmedizin Rostock
Rostock, 18057, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Evangelismos S A
Athens, 106 76, Greece
Hippokration Hospital
Athens, 115 27, Greece
Alexandra General Hospital of Athens
Athens, 115 28, Greece
Thoracic General Hospital Of Athens I Sotiria
Athens, 11527, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon
Nikaia, 184 54, Greece
Geniko Nosokomeio Peiraia Tzaneio
Piraeus, 18536, Greece
Theageneio Cancer Hospital
Thessaloniki, 546 39, Greece
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Semmelweis Egyetem 1
Budapest, 1082, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
Budapest, 1088, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, H-1136, Hungary
Vasutegeszsegugyi Nonprofit Kozhasznu Kft
Debrecen, 4025, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Szegedi Tudományegyetem Áok Szent-Györgyi Albert Klinikai Központ
Szeged, 6725, Hungary
Clinfan Ltd. SMO
Szekszárd, 7100, Hungary
Szent Borbala Hospital Tatabanya
Tatabánya, 2800, Hungary
Mazumdar Shaw Medical Centre - Narayana Hrudayalaya Limited
Bangalore, 560099, India
Aster CMI Hospital
Bengaluru, 560092, India
SUM Ultimate Medicare
Bhubaneswar, 751003, India
Lisie Hospital
Ernākulam, 682018, India
Fortis Memorial Research Institute
Gurugram, 122002, India
Asian Institute Of Gastroenterology
Hyderabad, 500032, India
Yashoda Super Speciality Hospitals 1
Hyderabad, 500082, India
S. R. Kalla Memorial General Hospital
Jaipur, 302001, India
Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines
Ludhiana, 141001, India
Fortis Hospital
Ludhiana, 141010, India
P D Hinduja National Hospital and Medical Research Center
Mumbai, 400016, India
Indraprastha Apollo Hospital
New Delhi, 1100776, India
Yashoda Super Speciality Hospitals
Secunderabad, 500003, India
SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
Surat, 395002, India
Gujarat Gastro and Vascular Hospital
Surat, 395009, India
Haemek Medical Center
Afula, 1834111, Israel
Assuta MC
Ashdod, 7747629, Israel
Shamir Medical Center Assaf Harofeh 1
Be’er Ya‘aqov, 70300, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 70300, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center 1
Jerusalem, 9103102, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center 1
Ramat Gan, 52621, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center 1
Tel Aviv, 64239, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria Careggi
Florence, 50134, Italy
Ospedale San Raffaele di Milano
Milan, 20132, Italy
ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi
Milan, 20154, Italy
Ospedale Sacro Cuore Negrar-Verona
Negrar-Verona, 37024, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, 00152, Italy
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Casa Sollievo Della Sofferenza IRCCS
San Giovanni Rotondo, 71013, Italy
Juntendo University Hospital Urayasu
Chiba, 279 0021, Japan
Ginza central clinic
Chūōku, 1040061, Japan
Sai Gastroenterology Proctology
Fujiidera-shi, 583-0027, Japan
Fukui Prefectural Hospital
Fukui-shi, 910-8526, Japan
Saiseikai Fukuoka General Hospital
Fukuoka, 810-0001, Japan
Gamagori City Hospital
Gamagōri, 443-8501, Japan
Matsuda Hospital
Hamamatsu, 432-8061, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193, Japan
Hirosaki General Medical Center
Hirosaki, 036-8545, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, 920-8650, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu, 807-8556, Japan
Kobe University Hospital
Kobe, 650 0017, Japan
Aoyama Naika Clinic
Kobe, 650-0015, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520, Japan
Takano Hospital
Kumamoto, 862-0971, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
Kyorin University Hospital
Mitaka, 181-8611, Japan
Takagi Clinic
Miyagi, 981-3213, Japan
Hyogo Medical University Hospital
Nishinomiya Shi, 663 8501, Japan
Nakagami Hospital
Okinawa, 904-2195, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540 0006, Japan
Japanese Red Cross Osaka Hospital
Osaka, 543-8555, Japan
Oita Red Cross Hospital
Ōita, 870-0033, Japan
Sapporo Tokushukai Hospital
Sapporo, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, 130 8575, Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, 411-8611, Japan
Yokohama City University Medical Center
Yokohama, 232 0024, Japan
Hospital Sultanah Bahiyah
Alor Star, 05460, Malaysia
Hospital Ampang
Ampang, 68000, Malaysia
Hospital Sultanah Aminah
Johor Bahru, 80100, Malaysia
Sultan Idris Shah Hospital
Kajang, 43000, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, 25100, Malaysia
Vrije Universiteit Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Maastricht UMC
Maastricht, 6229 HX, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Centrum Medyczne Medis ManerMed Sp Z O O
Bydgoszcz, 85 229, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85 231, Poland
Osrodek Badan Klinicznych CLINSANTE S C
Bydgoszcz, 85 794, Poland
Vita Longa Sp z o o
Katowice, 40 748, Poland
Malopolskie Badania Kliniczne Sp z o o
Krakow, 30 002, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
Centrum Medyczne Promed
Krakow, 31-513, Poland
Medrise Sp. z o.o.
Lublin, 20 582, Poland
Allmedica
Nowy Targ, 34 400, Poland
Medicus Zaniewski i Bilski
Olsztyn, 10-684, Poland
Twoja Przychodnia
Opole, 45-819, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp z o o
Poznan, 60 354, Poland
Pratia Poznan
Poznan, 60-192, Poland
RiverMED
Poznan, 61-441, Poland
Centrum Medyczne 'Medyk' Sp. z o.o. K.
Rzeszów, 35-055, Poland
Endoskopia Sp z o.o.
Sopot, 81 756, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
Sonomed Sp. z o.o.
Szczecin, 71-685, Poland
GASTROMED Sp. z o.o.
Torun, 87 100, Poland
Clinical Best Solutions Warszawa
Warsaw, 00-710, Poland
Medon Clinical Research
Warsaw, 02-679, Poland
WSD MEDI Clinical Sp. z o. o.
Warsaw, 02-786, Poland
Bodyclinic Sp. z o.o. sp. k
Warsaw, 03 712, Poland
Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O
Warsaw, 04 073, Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, 04 730, Poland
Medical Network WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
Centrum Medyczne Oporow
Wroclaw, 52 416, Poland
Przychodnia Vistamed
Wroclaw, 53 149, Poland
EMC Instytut Medyczny S A Penta Hospitals Przychodnie
Wroclaw, 54 239, Poland
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska
Włocławek, 87-800, Poland
ETG Zamosc
Zamość, 22 400, Poland
Uls Braga - Hosp. Braga
Braga, 4710 243, Portugal
Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, 4835 044, Portugal
Uls Santa Maria - Hosp. Santa Maria
Lisbon, 1649 028, Portugal
Uls Loures Odivelas - Hosp. Loures
Loures, 2674-514, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, 4050 385, Portugal
Ulsam - Hosp. Santa Luzia
Viana do Castelo, 4900-408, Portugal
S C Delta Health Care S R L
Bucharest, 014142, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
Cluj-Napoca, 400394, Romania
Gastromed S R L
Constanța, 900600, Romania
Spitalul Clinic Judetean de Urgenta Craiova
Craiova, 200147, Romania
Spitalul Clinic Judetean Sibiu
Sibiu, 550245, Romania
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Yeungnam University Hospital
Daegu, 42415, South Korea
The Catholic University of Korea Daejeon St Mary's Hospital
Daejeon, 34943, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Kyung Hee University Hospital
Seoul, 130 050, South Korea
Asan Medical Center
Seoul, 138-040, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Sant Joan de Deu
Barcelona, 08950, Spain
Hosp. Arquitecto Marcide
Ferrol, 15405, Spain
Hosp. Galdakao-Usansolo
Galdakao, 48960, Spain
Hosp. de Cabuenes
Gijón, 33394, Spain
Hosp. Univ. Dr. Josep Trueta
Girona, 17007, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Hosp. Alvaro Cunqueiro
Vigo, 36312, Spain
Alingsas lasarett
Allingsas, 441 83, Sweden
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Linkoping University Hospital
Linköping, 58185, Sweden
Orebro universitetssjukhus
Örebro, 703 82, Sweden
Ersta sjukhus
Stockholm, 116 30, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Department of Visceral Surgery and Medicine
Bern, 3010, Switzerland
HOCH Health Ostschweiz Kantonsspital St.Gallen
Sankt Gallen, 9007, Switzerland
Changhua Christian Hospital
Changhua, 500, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Mackay Memorial Hospital
Taipei, 104, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Hacettepe University Medical Faculty
Ankara, 06230, Turkey (Türkiye)
Gazi University Hospital 1
Ankara, 06560, Turkey (Türkiye)
Gazi University Hospital
Ankara, 06560, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Antalya Training And Research Hospital
Antalya, 07100, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, 34890, Turkey (Türkiye)
Marmara University Istanbul Pendik Education and Research Hospital 1
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35040, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty Hospital
Mersin, 33110, Turkey (Türkiye)
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Royal Hospital for Children and Young People
Edinburgh, EH16 4TJ, United Kingdom
Fairfield General Hospital
Greater Manchester, BL9 7TD, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
St Georges University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Whiston Hospital
Rainhill, L35 5DR, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
Stepping Hill Hospital
Stockport, SK104JX, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This study is double-blind for adults and open-label for adolescent participants.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2025
First Posted
September 29, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
January 14, 2028
Study Completion (Estimated)
January 13, 2032
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu