A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
SIBERITE-1
A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
2 other identifiers
interventional
600
37 countries
352
Brief Summary
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2025
Longer than P75 for phase_3
352 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
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedStudy Start
First participant enrolled
March 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
May 4, 2026
May 1, 2026
3.8 years
February 6, 2025
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score
Percentage of participants achieving a CDAI score of \<150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.
At Week 52
Percentage of Participants with Endoscopic Response
Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>=50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.
At Week 52
Secondary Outcomes (28)
Percentage of Participants with Clinical Remission
At Week 12
Percentage of Participants with Endoscopic Response
At Week 12
Percentage of Participants with Symptomatic Remission
At Week 12
Percentage of Participants with Endoscopic Remission
At Week 12
Percentage of Participants with Ulcer-free Endoscopy
At Week 12
- +23 more secondary outcomes
Study Arms (3)
Arm 1: Afimkibart
EXPERIMENTALParticipants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Arm 2: Afimkibart
EXPERIMENTALParticipants will receive afimkibart IV followed by afimkibart SC injection.
Arm 3: Placebo
PLACEBO COMPARATORParticipants will receive placebo IV followed by placebo SC.
Interventions
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of CD
- Moderately to severely active CD
- Bodyweight \>= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
You may not qualify if:
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Participant with a history of \>= 3 bowel resections (\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \>3 openings
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia
- History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Chugai Pharmaceuticalcollaborator
Study Sites (362)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, Alabama, 36305, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, 85351, United States
University of Arizona-CATS Research Center
Tucson, Arizona, 85724, United States
Valley View Internal Medicine
Garden Grove, California, 92845-2006, United States
310 Clinical Research
Inglewood, California, 90301, United States
UCSD Medical Center
La Jolla, California, 92037-0897, United States
Gastro Care Associates
Lancaster, California, 93534, United States
Om Research LLC
Lancaster, California, 93534, United States
United Gastroenterologists
Los Alamitos, California, 90720, United States
Acclaim Clinical Research, Inc.
San Diego, California, 92120, United States
Kaiser Permanente
San Francisco, California, 94115, United States
UCSF/Medical Center at Mount Zion
San Francisco, California, 94115, United States
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120, United States
Peak Gastroenterology Surgery Center
Lone Tree, Colorado, 80124, United States
Access Research Institute
Brooksville, Florida, 34613, United States
Gastro Florida
Clearwater, Florida, 33756, United States
HealthMed Clinical Center Inc.
Coral Gables, Florida, 33134, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134, United States
The Sister Life Research
Hialeah, Florida, 33013, United States
NeoClinical Research
Hialeah, Florida, 33016, United States
Clinical Research of Osceola, LLC
Kissimmee, Florida, 34741, United States
Florida Research Institute - Lakewood
Lakewood Rch, Florida, 34211, United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126, United States
Ambert Medical Research
Miami, Florida, 33176, United States
Orlando Regional Healthcare
Orlando, Florida, 32806, United States
Nodal Medical Center Research - NMC
Tampa, Florida, 33607, United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida, 33612, United States
Guardian Angel Research Center, LLC
Tampa, Florida, 33614, United States
Theia Clinical Research Centers, LLC
Temple Terrace, Florida, 33617, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Florida Medical Clinic - Orlando Health
Zephyrhills, Florida, 33542, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois, 60026, United States
GI Alliance - Gurnee
Gurnee, Illinois, 60031, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150, United States
Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas, 67226, United States
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017-3409, United States
Gastroenterology Health Partners, PLLC
Louisville, Kentucky, 40218, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University
Boston, Massachusetts, 02118, United States
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334, United States
Gastroenterology Associates and Endoscopy Center of North Mississippi
Oxford, Mississippi, 38655, United States
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, 38671, United States
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030, United States
Mount Sinai Hospital - IBD Clinical Center
New York, New York, 10029, United States
Lenox Hill Hospital
New York, New York, 10075, United States
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, 11758, United States
Queens Village Medical Care
Queens Village, New York, 11428, United States
Mainstreet - Richmond Hill Clinic
Richmond Hill, New York, 11418, United States
Gastroenterology Group Of Rochester, LLP
Rochester, New York, 14618, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Atrium Health, Carolinas Healthcare System
Charlotte, North Carolina, 28204, United States
Omega Research North Carolina, LLC
Fuquay-Varina, North Carolina, 27526, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440, United States
Digestive Disease Consultants
Brunswick, Ohio, 44212, United States
University of Cincinnati Hospital
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Gastroenterology Group
Columbus, Ohio, 43202, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Gastro Health- Liberty
Liberty Township, Ohio, 45044, United States
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, 44145, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, 15401-9069, United States
University Gastroenterology
Providence, Rhode Island, 02904, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Gastroenterology Associates
Greenville, South Carolina, 29607, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Proactive El Paso,LLC
El Paso, Texas, 79902, United States
Amel Med LLC
Georgetown, Texas, 78628, United States
Cano Medical Center
Harlingen, Texas, 78550, United States
TDDC dba GI Alliance Research
Mansfield, Texas, 76063, United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149, United States
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229, United States
GI Alliance - Southlake
Southlake, Texas, 76092, United States
Baylor Scott and White Medical Center
Temple, Texas, 76508, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake, Virginia, 23320, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176, United States
Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, 24502, United States
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014, United States
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
Williamsburg, Virginia, 23188, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
Hospital Britanico
Ciudad Autonoma Bs As, C1280AEB, Argentina
Hospital Provincial del Centenario
Rosario, S2002KDS, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Mater Misericordiae Limited
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Center
Adelaide, South Australia, 5042, Australia
Lyell McEwin Hospital
Adelaide, South Australia, 5112, Australia
Northern Hospital
Epping, Victoria, 3076, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, 3100, Austria
Barmherzige Brüder Wien
Vienna, 1020, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
AZORG Campus Aalst-Moorselbaan
Aalst, 9300, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
CHC MontLégia
Liège, 4000, Belgium
CHU de Liège (Sart Tilman)
Liège, 4000, Belgium
CHU HELORA - Hôpital de Mons - Site Kennedy
Mons, 7000, Belgium
Vitaz
Sint-Niklaas, 9100, Belgium
CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, Estado de Bahia, 41500-300, Brazil
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
Brasília, Federal District, 70200-730, Brazil
Centro Digestivo de Curitiba
Curitiba, Paraná, 80430-160, Brazil
Hospital de Clinicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Centro de Pesquisa São Lucas
Campinas, São Paulo, 13060-904, Brazil
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, 01228-000, Brazil
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, 03325-050, Brazil
MHAT St. Ivan Rilski
Gorna Oryahovitsa, 5100, Bulgaria
Futuremeds Medical Center
Plovdiv, 4000, Bulgaria
MHAT Saint Karidad EAD
Plovdiv, 4000, Bulgaria
South Edmonton Gastroenterology
Edmonton, Alberta, T6K 4B2, Canada
TDDA Specialty Research
Vaughan, Ontario, L4L 4Y7, Canada
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
Hospital Guillermo Grant Benavente
Concepción, 4030000, Chile
Medwal
Santiago, 7500000, Chile
Clinica Universidad de Los Andes
Santiago, Chile
Peking University Third Hospital
Beijing, 100191, China
the First Hospital of Jilin University
Changchun, 130021, China
Third Xiangya Hospital Centrel South University
Changsha, 410013, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Chongqing General Hospital
Chongqing, 401147, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005, China
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260, China
The sixth affiliated hospital of Sun Yat-Sen University
Guangzhou, 510655, China
Zhejiang Province Traditional Chinese Medical Hospital
Hangzhou, 310006, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016, China
Anhui Provincial Hospital
Hefei, 230001, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Huizhou Central People's Hospital
Huizhou, 516001, China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006, China
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021, China
The First Affiliated Hospital of Ningbo University
Ningbo, 315000, China
Shanghai East Hospital
Shanghai, 200126, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
Taizhou Hospital Of Zhejiang Province
Taizhou, 318050, China
The Central Hospital of Wuhan
Wuhan, 430014, China
Ren Min Hospital Affiliated Wu Han University
Wuhan, 430060, China
Wuxi People's Hospital
Wuxi, 214023, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zhuzhou Central Hospital
Zhuzhou, 412007, China
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogota, D.C., 111321, Colombia
Clinica del Country
Bogotá, 11001, Colombia
Hospital Pablo Tobon Uribe
Medellín, 050034, Colombia
Borzan Polyclinic
Osijek, 31000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
SurGal Clinic s.r.o.
Brno, 602 00, Czechia
Nemocnice Ceske Budejovice a.s.
České Budějovice, 370 01, Czechia
Gastroenterologie s.r.o.
Hradec Králové, 500 02, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Herlev Hospital
Herlev, 2730, Denmark
CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)
Santo Domingo, 10134, Dominican Republic
CHU Amiens - Hopital Sud
Amiens, 80054, France
Hopital Nord
Marseille, 13015, France
CHU Nice - Hopital de l'Archet 2
Nice, 06202, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604, France
Hopital Robert Debre
Reims, 51092, France
CHU de Rennes - Hopital de Pontchaillo
Rennes, 35033, France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Charite - Campus Benjamin Franklin
Berlin, 12203, Germany
AGAPLESION Markus-Krankenhaus
Frankfurt, 60431, Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, 60590, Germany
Universitaetsklinikum Halle (Saale)
Halle, 06120, Germany
Med. Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Jena
Jena, 77430, Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167, Germany
Universitätsklinikum Ulm
Ulm, 89081, Germany
Celan S.A.
Guatemala City, 01010, Guatemala
Medi-k
Guatemala City, 01016, Guatemala
Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036, Hungary
Semmelweis Egyetem
Budapest, 1088, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Clinexpert Gyongyos Kft
Gyöngyös, 3200, Hungary
Clinfan Szolgaltato Kft.
Szekszárd, 7100, Hungary
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
Székesfehérvár, 8000, Hungary
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005, India
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, 395002, India
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009, India
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041, India
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, 440018, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302006, India
AIG Hospitals
Gachibowli, Telangana, 500032, India
Gandhi Hospital
Secunderabad, Telangana, 500003, India
Yashoda Hospitals
Secunderabad, Telangana, 500003, India
Soroka University Medical Centre
Beersheba, Negev, 84101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia, 70124, Italy
Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro
Catanzaro, Calabria, 88100, Italy
Universita'degli Studi di Napoli Federico II
Naples, Campania, 80131, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00151, Italy
Ospedale Isola Tiberina Gemelli
Rome, Lazio, 00186, Italy
ASST Fatebenefratelli-Sacco, Polo "Ospedale Fatebenefratelli ed oftalmico"
Milan, Lombardy, 20121, Italy
Asst Santi Paolo E Carlo
Milan, Lombardy, 20142, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza MI, Lombardy, 20900, Italy
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100, Italy
ASST Rhodense - Ospedale di Rho
Rho, Lombardy, 20017, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089, Italy
IRCCS Ospedale Casa Sollievo della Soffenza
San Giovanni Rotondo, Lombardy, 71013, Italy
Ospedale Mauriziano Umberto I
Turin, Piedmont, 10128, Italy
Azienda Ospedaliero - Universitaria di Cagliari
Monserrato, Sardinia, 09042, Italy
A.O.U Careggi
Florence, Tuscany, 50124, Italy
Azienda Ospedaliera di Padova
Padova, Veneto, 35128, Italy
Asahikawa Medical University Hospital
Asahikawa-shi, Hokkaido, 078-8510, Japan
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017, Japan
Takagi clinic
Sendai, Miyagi, 981-3213, Japan
Gamagori City Hospital
Aichi, 443-8501, Japan
Nagoya City University Hospital
Aichi, 467-8602, Japan
National Hospital Organization Hirosaki General Medical Center
Aomori, 036-8545, Japan
Asahikawa City Hospital
Asahikawa-shi, 070-8610, Japan
Tsujinaka Hospital Kashiwanoha
Chiba, 277-0871, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502, Japan
Ehime Prefectural Central Hospital
Ehime, 790-0024, Japan
Fukui Prefectural Hospital
Fukui, 910-8526, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kurume University Hospital
Fukuoka, 830-0011, Japan
Kitakyushu Municipal Medical Center
Fukuoka, Japan
Hiroshima Prefectural Hospital
Hiroshima, 734-8530, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Sapporo Kosei General Hospital
Hokkaido, 060-0033, Japan
Sapporo Medical University Hospital
Hokkaido, 060-8543, Japan
Medical Corporation Sapporo IBD Clinic
Hokkaido, 064-0919, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Ishikawa Prefectural Central Hospital
Ishikawa, 920-8530, Japan
Kagawa Prefectural Central Hospital
Kagawa, 760-8557, Japan
Sameshima Hospital
Kagoshima, 892-0846, Japan
Yokohama City University Medical Center
Kanagawa, 232-0024, Japan
Gokeikai Ofuna Chuo Hospital
Kanagawa, 247-0056, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520, Japan
Sendai Kousei Hospital
Miyagi, 981-0914, Japan
Sendai Medical Center
Miyagi, 983-8520, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kinshukai Infusion Clinic
Osaka, 530-0011, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Saga-ken Medical Centre Koseikan
Saga, 840-8571, Japan
Saga University Hospital
Saga, 849-8501, Japan
National Hospital Organization Shizuoka Medical Center
Shizuoka, 411-8611, Japan
Hamamatsu University Hospital
Shizuoka, 431-3192, Japan
Matsuda Hospital
Shizuoka, 432-8061, Japan
Institute of Science Tokyo Hospital
Tokyo, 113-8519, Japan
Tokyo Metropolitan Bokutoh Hospital
Tokyo, 130-8575, Japan
Keio University Hospital
Tokyo, 160-8582, Japan
National Center for Global Health and Medicine
Tokyo, 162-0052, Japan
JCHO Tokyo Yamate Medical Center
Tokyo, 169-0073, Japan
Kyorin University Hospital
Tokyo, 181-8611, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Japanese Red Cross Wakayama Medical Center
Wakayama, 640-8558, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506, Japan
Boca Clinical Trials Mexico S.C. (Guadalajara)
Guadalajara, Jalisco, 44600, Mexico
Hospital General de Mexico
Mexico, Tlaxcala, 06726, Mexico
Medical Care & Research SA de CV
Mérida, Yucatán, 97000, Mexico
Ziekenhuis Rijnstate
Arnhem, 6815 AD, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG, Netherlands
ETZ Elisabeth
Tilburg, 5022 GC, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
Gastroenterólogos y Asociados
Panama City, 07192, Panama
Instituto de Investigación e Innovación y Gestión del Conocimiento (III-GC)
Panama City, 0801, Panama
SPZOZ w ??cznej
??czna, 21-010, Poland
Clinical Trials UMED Sp. z o. o.
?ód?, 92-213, Poland
Uniwersytecki Szpital Kliniczny W Bia?Ymstoku
Bia?ystok, 15-276, Poland
Centrum Medyczne "Medis"
Bydgoszcz, 85-229, Poland
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
Chojnice, 89-600, Poland
Endo-Med Sp. z o.o.
Karczew, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Krakowskie Centrum Medyczne - Part of Futuremeds
Krakow, 31-501, Poland
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, 34-400, Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, 10-561, Poland
NZOZ Eskulap Pabianice
Pabianice, 95-200, Poland
Trialmed CRS
Piotrkow Trybunalski, 97-300, Poland
SOLUMED Centrum Medyczne
Późna, 60-529, Poland
Centrum Medyczne "MEDYK"
Rzeszów, 35-326, Poland
Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
Staszów, 20-200, Poland
Gastromed Sp. z o.o.
Toru?, 87-100, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507, Poland
Melita Medical
Wroc?aw, 50-449, Poland
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroc?aw, 53-149, Poland
Penta Hospitals Przychodnie, Wroclaw Wejherowska
Wroc?aw, 54-239, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
ETG Zamosc
Zamość, 22-400, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Hospital de Sao Joao
Porto, 4202-451, Portugal
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, 4520-211, Portugal
Hospital Sao Teotonio
Viseu, 3504-509, Portugal
Klinical Investigations Group LLC
San Juan, 00909, Puerto Rico
University of Puerto Rico Medical Sciences Campus
San Juan, 00936-5067, Puerto Rico
Colentina Clinical Hospital
Bucharest, 020125, Romania
Cantacuzino Clinical Hospital
Bucharest, 020475, Romania
University Hospital Center Dr Dragisa Misovic - Dedinje
Belgrade, 11040, Serbia
Clinical Hospital Center Zemun
Belgrade, 11080, Serbia
University Hospital Medical Center Bezanijska Kosa
Belgrade, 11080, Serbia
University Hospital Medical Center Zvezdara
Belgrade, 11120, Serbia
Clinical Center of Vojvodina
Novi Sad, 21137, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, 23000, Serbia
Cliniq s.r.o.
Bratislava, 811 09, Slovakia
Nemocnica Bory -Penta Hospitals
Bratislava, 841 03, Slovakia
Endomed, s.r.o.
Košice, 040 01, Slovakia
Ustredna vojenska nemocnica SNP Ruzomberok ? FN
Ružomberok, 034 26, Slovakia
Inje university Haeundae Paik Hospital
Busan, 48108, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
The Catholic University of Korea Daejeon ST. Mary?s Hospital
Daejeon, 34943, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 26426, South Korea
Hanyang University Guri Hospital
Guri-si, 11923, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Ewha Womans University Hospital (Seoul)
Seoul, 07804, South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital de Galdakao
Galdacao, Vizcaya, 48960, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Reina Sofía
Murcia, 30003, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Hospital Universitario Rio Hortega
Valladolid, 47012, Spain
National Taiwan University Hospital
Taipei, Zhongzheng District, 100, Taiwan
E-Da Hospital
Kaohsiung City, 82445, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
Bangkok, 10330, Thailand
Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
Bangkok, 10700, Thailand
Khon Kaen Uni
Khon Kaen, 40002, Thailand
Thammasat University Hospital
Pathum Thani, 12120, Thailand
Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
Songkhla, 90110, Thailand
Sheikh Shakhbout Medical City
Abu Dhabi, 11001, United Arab Emirates
Sheikh Khalifa Medical City (SKMC)
Abu Dhabi, 51900, United Arab Emirates
Burjeel Hopital
Abu Dhabi, 7400, United Arab Emirates
Rashid Hospital
Dubai, 4545, United Arab Emirates
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
St Mark's Hospital & Imperial College
Harrow, HA1 3UJ, United Kingdom
Royal Liverpool University Hospital
Liverpool, L7 8XP, United Kingdom
King College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Queen Anne Street Medical Centre
London, W1T 6AH, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
North Tyneside General Hospital
North Shields, NE29 8NH, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham, NG7 2UH, United Kingdom
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Central Study Contacts
Reference Study ID Number: GA45331 https://forpatients.roche.com/
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 11, 2025
Study Start
March 17, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2033
Last Updated
May 4, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing