A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
ICONIC-CD
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
2 other identifiers
interventional
1,092
28 countries
324
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2025
Longer than P75 for phase_2
324 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 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 6, 2032
March 12, 2026
March 1, 2026
3 years
September 22, 2025
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Induction Study 1: Number of Participants with Clinical Response at Week 12
Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 12
Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)
Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 12
Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)
Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 12
Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)
Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.
At Week 40
Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)
Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.
At Week 40
Secondary Outcomes (24)
Induction Study 1: Number of Participants with Clinical Remission at Week 12
At Week 12
Induction Study 1: Number of Participants with Endoscopic Response at Week 12
At Week 12
Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 4 weeks after last dose of study drug (i.e., up to Week 16)
Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12
At Week 12
Induction Study 2: Number of Participants with Clinical Response at Week 12
At Week 12
- +19 more secondary outcomes
Study Arms (8)
Induction Study 1: Icotrokinra Dose 1
EXPERIMENTALParticipants 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.
Induction Study 1: Icotrokinra Dose 2
EXPERIMENTALParticipants 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.
Induction Study 1: Placebo
PLACEBO COMPARATORParticipants 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.
Induction Study 2: Icotrokinra
EXPERIMENTALParticipants 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.
Induction Study 2: Placebo
PLACEBO COMPARATORParticipants will receive matching placebo for up to Week 12. Subsequent study treatment will be determined by the participant's response status at Week 12.
Maintenance Study: Icotrokinra Dose 1
EXPERIMENTALParticipants 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).
Maintenance Study: Icotrokinra Dose 2
EXPERIMENTALParticipants 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.
Maintenance Study: Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Icotrokinra will be administered orally, daily.
Matching placebo will be administered orally, daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention
- Presence of a stoma or ostomy
- Participants with presence of active fistulas may be included if there is no surgery needed
- Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline
- Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (324)
AZ Gastro Care
Chandler, Arizona, 85206, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Clinnova Research
Anaheim, California, 92805, United States
Alliance Research Institute, LLC - Canoga Park
Canoga Park, California, 91304, United States
Southern California Research Center
Coronado, California, 92118, United States
Om Research, LLC 1
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
American Institute of Research
Cutler Bay, Florida, 33157, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Green Leaf Clinical Trials
Jacksonville, Florida, 32258, United States
Florida Research Center Inc.
Lakewood Rch, Florida, 34211, United States
Sanchez Clinical Research, Inc
Miami, Florida, 33157-6575, United States
GCP Clinical Research
Tampa, Florida, 33609, United States
Children's Center for Digestive Health Care
Atlanta, Georgia, 30342, United States
Gastroenterolgy Associates of Central GA
Macon, Georgia, 31201, United States
IU Health University Hospital
Indianapolis, Indiana, 46202, United States
Kansas Gastroenterology, LLC
Wichita, Kansas, 67226, United States
Tri-State Gastroenterology Assoc
Crestview Hills, Kentucky, 41017, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, 70503, 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
Mayo Clinic 1
Rochester, Minnesota, 55905, United States
Westchester Putnam Gastroenterology
Carmel, New York, 10512, United States
Inflammatory Bowel Disease Center at NYU Langone
New York, New York, 10016, United States
Manhattan Clinical Research LLC
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10065, United States
New York Gastroenterology Associates
New York, New York, 10075, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, 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
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
DFW Clinical Trials
Carrollton, Texas, 75010, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Victorium Clinical Research
Houston, Texas, 77024, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
GEDYT
AAI, C1425BGC, Argentina
Hospital Britanico de Buenos Aires
CABA, C1280AEB, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, X5004FHP, Argentina
Hospital Privado de Cordoba
Córdoba, XX5016KEH, 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
Mater Hospital Brisbane
South Brisbane, 4101, Australia
CHU Saint-Pierre
Brussels, 1000, 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
Unesp
Botucatu, 18618 686, Brazil
L2IP Instituto de Pesquisas Clinicas
Brasília, 70200 730, Brazil
Chronos Clinica Medica Ltda
Brasília, 72145-450, Brazil
CDC - Centro Digestivo de Curitiba
Curitiba, 80430 180, Brazil
ATO Terapias
Fortaleza, 60140 025, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000, Brazil
Complexo Hospitalar de Niteroi
Niterói, 24030-103, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, 90035 903, Brazil
Platano Centro De Pesquisa Clinica LTDA
Recife, 52011 200, Brazil
Clinica Ibis Medicina Ltda
Salvador, 41820-020, Brazil
Pesquisare Saude
Santo André, 09080-110, Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos, 11075-101, Brazil
Hospital de Base da Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, 15090 000, Brazil
Solare Trials
São Paulo, 01307 002, 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
ABP Research Services Corp.
Oakville, Ontario, L6L 5L7, Canada
Toronto Immune and Digestive Health Institute Inc
Toronto, Ontario, M6A 3B4, Canada
Capital Medical University, Beijing Friendship Hospital
Beijing, 100050, China
Xiangya Hospital Central South University
Changsha, 410008, China
The second Xiangya Hospital of Central South University
Changsha, 410011, China
Changzhou No 2 Peoples Hospital
Changzhou, 213003, China
West China Hospital Si Chuan University
Chengdu, 610041, China
Chongqing General Hospital
Chongqing, 400014, China
The First People's Hospital of Foshan
Foshan, 528000, 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, 510261, 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, 310016, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huizhou Central People's Hospital
Huizhou, 516001, China
Jinhua municipal central hospital
Jinhua, 321013, China
The first affiliated hospital of Henan University of science and technology
Luoyang, 471003, China
Zhongda Hospital Southeast University
Nanjing, 210000, China
Ningbo medical center lihuili hospital
Ningbo, 315000, China
Huashan Hospital Fudan University
Shanghai, 200040, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
Shenzhen Hospital of Southern Medical University
Shenzhen, 518101, China
Second Affiliated Hospital of Soochow University
Suzhou, 215000, China
The 2nd Affiliated Hospital & Yuying Children s Hospital Wenzhou Medical University
Wenzhou, 325026, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Zhongshan Hospital, Xiamen University
Xiamen, 361004, China
Northern Jiangsu Peoples Hospital
Yangzhou, 225001, China
ZhuZhou Central Hospital
Zhuzhou, 412007, China
Affiliated Hospital of Zunyi Medical University
Zunyi, 563099, China
Fakultni nemocnice Brno
Brno, 62500, Czechia
Vojenska nemocnice Brno
Brno, 636 00, Czechia
Centrum gastroenterologie a hepatologie s.r.o.
Kladno, 27280, Czechia
PreventaMed, s.r.o.
Olomouc, 77900, Czechia
Gastromedic, Ltd.
Pardubice, 530 03, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00, Czechia
AXON Clinical s.r.o.
Prague, 140 00, 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, 64100, 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
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, 06202, France
Hopital Saint-Antoine
Paris, 75012, 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
DRK Kliniken Berlin Westend
Berlin, 14050, Germany
Medizinisches Versorgungszentrum (MVZ) Dachau
Dachau, 85221, Germany
BSF Studiengesellschaft
Halle, 06108, Germany
Praxisgemeinschaft Jerichow
Jerichow, 39319, Germany
Universitatsklinikum Schleswig Holstein Kiel
Kiel, 24105, Germany
Eugastro GmbH
Leipzig, 04103, Germany
Praxis fuer Gastroenterologie
Lübeck, 23560, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Universitaetsmedizin Rostock
Rostock, 18057, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
Evangelismos S A
Athens, 106 76, Greece
Thoracic General Hospital Of Athens I Sotiria
Athens, 11527, Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Athens, 12462, Greece
University General Hospital of Heraklion
Heraklion, 715 00, Greece
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon
Nikaia, 184 54, Greece
Tzanio General Hospital of Piraeus
Piraeus, 185 36, Greece
Theageneio Cancer Hospital
Thessaloniki, 546 39, Greece
Ippokratio General Hospital Of Thessaloniki
Thessaloniki, 546 42, Greece
Bekes Varmegyei KK Dr Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, 1036, Hungary
Semmelweis Egyetem
Budapest, 1082, Hungary
Semmelweis Egyetem
Budapest, 1083, Hungary
Semmelweis Egyetem, Belgyogyaszati es Hematologiai Klinika
Budapest, 1088, Hungary
Pannónia Magánorvosi Centrum Kft
Budapest, 1136, 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
Asian Institute Of Gastroenterology
Hyderabad, 500032, India
Yashoda Super Speciality Hospitals
Hyderabad, 500082, India
S. R. Kalla Memorial General Hospital
Jaipur, 302001, 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
Ha'Emek Medical Center
Afula, 1834111, Israel
Assuta MC
Ashdod, 7747629, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 70300, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Galilee Medical Center
Nahariya, 2210001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
ARNAS G Brotzu
Cagliari, 09121, Italy
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, 20122, Italy
Ospedale San Raffaele di Milano
Milan, 20132, 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
Juntendo University Hospital Urayasu
Chiba, 279 0021, Japan
Fukui Prefectural Hospital
Fukui-shi, 910-8526, Japan
Gamagori City Hospital
Gamagōri, 443-8501, Japan
Hamamatsu University Hospital
Hamamatsu, 431-3192, Japan
Matsuda Hospital
Hamamatsu, 432-8061, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun, 311-3193, Japan
Kagoshima IBD Gastroenterology Clinic
Kagoshima, 892-0843, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871, Japan
Saitama Medical Center
Kawagoe, 350-8550, Japan
Hospital of the University of Occupational and Environmental Health
Kitakyushu, 807-8556, 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
Osaka Metropolitan University Hospital
Osaka, 545 8586, Japan
Saga University Hospital
Saga, 849 0937, Japan
Toho University Sakura Medical Center
Sakura, 285-0841, Japan
Sapporo Tokushukai Hospital
Sapporo, 004-0041, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 060-0033, Japan
Sapporo IBD Clinic
Sapporo, 064-0919, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
National Center for Global Health and Medicine
Shinjuku- Ku, 162-8655, Japan
Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073, Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, 411-8611, Japan
Hospital Sultanah Bahiyah
Alor Star, 05460, Malaysia
Hospital Ampang
Ampang, 68000, Malaysia
Hospital Sultanah Aminah
Johor Bahru, 80100, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
Sultan Ahmad Shah Medical Centre IIUM
Kuantan, 25200, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Vrije Universiteit Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Maastricht UMC
Maastricht, 6229 HX, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Centrum Medyczne Medis
Bydgoszcz, 85 229, Poland
NZOZ Centrum Medyczne KERmed
Bydgoszcz, 85 231, Poland
Osrodek Badan Klinicznych CLINSANTE S C
Bydgoszcz, 85 794, Poland
Centrum Medyczne Plejady
Krakow, 30 363, Poland
Malopolskie Badania Kliniczne
Krakow, 30-002, 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 Opolskie Centrum Medyczne
Opole, 45-819, Poland
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp z o o
Poznan, 60 354, Poland
RiverMED
Poznan, 61-441, Poland
Centrum Medyczne Medyk
Rzeszów, 35-326, 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
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
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
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
Hosp. Lusiadas Lisboa
Lisbon, 1500-458, 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
S C Delta Health Care S R L
Bucharest, 014142, Romania
Spitalul Clinic Colentina
Bucharest, 020125, Romania
Digenio - Centrul Medical de Gastroenterologie, Hepatologie si Endoscopie Digestiva
Cluj-Napoca, 400061, 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 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
Kyung Hee University Hospital
Dongdaemun-gu, 02447, 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
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic university of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Hosp. Clinic de Barcelona
Barcelona, 08036, 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. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Virgen Macarena
Seville, 41009, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Alingsas lasarett
Allingsas, 441 83, Sweden
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Linkoping University Hospital
Linköping, 581 85, 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
Inselspital Universitatsspital Bern
Bern, 3010, Switzerland
Kantonsspital Sankt 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 Hospital
Ankara, 06230, 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)
Koc University, School of Medicine, Koc University Hospital
Istanbul, 34010, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi
Izmir, 35100, Turkey (Türkiye)
Izmir Sehir Hastanesi
Izmir, 35540, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33110, Turkey (Türkiye)
Queen Elizabeth Hospital Birmingham
Birmingham, B15 2GW, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Glasgow Royal Infirmary
Glasgow, G31 2ER, United Kingdom
Fairfield General Hospital
Greater Manchester, BL9 7TD, United Kingdom
Whipps Cross University Hospital
London, E11 1NR, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
St Georges University Hospital NHS Foundation Trust
London, SW17 0RE, United Kingdom
Whiston Hospital
Rainhill, L35 5DR, United Kingdom
Stepping Hill Hospital
Stockport, SK2 7JE, 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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- 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 3, 2025
Primary Completion (Estimated)
September 19, 2028
Study Completion (Estimated)
October 6, 2032
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.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