Moderately to Severely Active Crohns DiseasePhase 3SIBERITE-1NCT06819878
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
A Phase 3 study testing Afimkibart in people with Moderately to Severely Active Crohns Disease, run by Hoffmann-La Roche at 375 sites in 38 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Moderately to Severely Active Crohns Disease
- What is being tested?
- Afimkibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 375 sitesin 38 countries
- Study dates
- 17 Mar 2025to 31 Dec 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
375 sites in 38 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GA45331 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
375 sites in 38 countries
United States95 sites, 92 recruiting
- Recruiting
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
- Recruiting
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327
- Recruiting
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
- Recruiting
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, 45440
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Boston University
Boston, Massachusetts, 02118
- Recruiting
Access Research Institute
Brooksville, Florida, 34613
- Recruiting
Digestive Disease Consultants
Brunswick, Ohio, 44212
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Atrium Health, Carolinas Healthcare System
Charlotte, North Carolina, 28204
- Recruiting
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
Chesapeake, Virginia, 23320
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
- Recruiting
University of Cincinnati Hospital
Cincinnati, Ohio, 45267
- Recruiting
Gastro Florida
Clearwater, Florida, 33756
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- Recruiting
Ohio Gastroenterology Group
Columbus, Ohio, 43202
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
- Recruiting
HealthMed Clinical Center Inc.
Coral Gables, Florida, 33134
- Recruiting
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134
- Recruiting
Tri-State Gastroenterology Associates
Crestview Hills, Kentucky, 41017-3409
- Recruiting
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
Dothan, Alabama, 36305
- Recruiting
Proactive El Paso,LLC
El Paso, Texas, 79902
- Recruiting
Michigan Center of Medical Research
Farmington Hills, Michigan, 48334
- Recruiting
Omega Research North Carolina, LLC
Fuquay-Varina, North Carolina, 27526
- Recruiting
Valley View Internal Medicine
Garden Grove, California, 92845-2006
- Recruiting
Amel Med LLC
Georgetown, Texas, 78628
- Recruiting
Gastro One
Germantown, Tennessee, 38138
- Recruiting
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois, 60026
- Recruiting
Gastroenterology Associates
Greenville, South Carolina, 29607
- Recruiting
GI Alliance - Gurnee
Gurnee, Illinois, 60031
- Recruiting
Cano Medical Center
Harlingen, Texas, 78550
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
The Sister Life Research
Hialeah, Florida, 33013
- Recruiting
NeoClinical Research
Hialeah, Florida, 33016
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
- Recruiting
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
- Recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
- Recruiting
310 Clinical Research
Inglewood, California, 90301
- Recruiting
Clinical Research of Osceola, LLC
Kissimmee, Florida, 34741
- Recruiting
UCSD Medical Center
La Jolla, California, 92037-0897
- Recruiting
University of California San Diego
La Jolla, California, 92037-0897
- Recruiting
Florida Research Institute - Lakewood
Lakewood Rch, Florida, 34211
- Recruiting
Gastro Care Associates
Lancaster, California, 93534
- Recruiting
Om Research LLC
Lancaster, California, 93534
- Recruiting
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176
- Recruiting
Gastro Health- Liberty
Liberty Township, Ohio, 45044
- Recruiting
Rocky Mountain Gastroenterology
Littleton, Colorado, 80120
- Recruiting
Peak Gastroenterology Surgery Center
Lone Tree, Colorado, 80124
- Recruiting
United Gastroenterologists
Los Alamitos, California, 90720
- Recruiting
Gastroenterology Health Partners, PLLC
Louisville, Kentucky, 40218
- Recruiting
Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia
Lynchburg, Virginia, 24502
- Recruiting
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201
- Recruiting
TDDC dba GI Alliance Research
Mansfield, Texas, 76063
- Recruiting
SMS Clinical Research, LLC
Mesquite, Texas, 75149
- Recruiting
LCC Medical Research Institute, LLC
Miami, Florida, 33126
- Withdrawn
Ambert Medical Research
Miami, Florida, 33176
- Recruiting
Monroe Biomedical Research
Monroe, North Carolina, 28112
- Recruiting
Quality Medical Research
Nashville, Tennessee, 37211
- Recruiting
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150
- Recruiting
Mount Sinai Hospital - IBD Clinical Center
New York, New York, 10029
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
- Recruiting
Central Sooner Research
Norman, Oklahoma, 73071
- Recruiting
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030
- Recruiting
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, 11758
- Recruiting
Orlando Regional Healthcare
Orlando, Florida, 32806
- Recruiting
Gastroenterology Associates and Endoscopy Center of North Mississippi
Oxford, Mississippi, 38655
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
University Gastroenterology
Providence, Rhode Island, 02904
- Recruiting
Queens Village Medical Care
Queens Village, New York, 11428
- Recruiting
Mainstreet - Richmond Hill Clinic
Richmond Hill, New York, 11418
- Recruiting
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
Roanoke, Virginia, 24014
- Recruiting
Gastroenterology Group Of Rochester, LLP
Rochester, New York, 14618
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Recruiting
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229
- Withdrawn
Acclaim Clinical Research, Inc.
San Diego, California, 92120
- Recruiting
Kaiser Permanente
San Francisco, California, 94115
- Recruiting
UCSF/Medical Center at Mount Zion
San Francisco, California, 94115
- Withdrawn
Virginia Mason Medical Center
Seattle, Washington, 98101
- Recruiting
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, 38671
- Recruiting
GI Alliance - Southlake
Southlake, Texas, 76092
- Recruiting
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, 85351
- Recruiting
Nodal Medical Center Research - NMC
Tampa, Florida, 33607
- Recruiting
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida, 33612
- Recruiting
Guardian Angel Research Center, LLC
Tampa, Florida, 33614
- Recruiting
Baylor Scott and White Medical Center
Temple, Texas, 76508
- Recruiting
Theia Clinical Research Centers, LLC
Temple Terrace, Florida, 33617
- Recruiting
University of Arizona-CATS Research Center
Tucson, Arizona, 85724
- Recruiting
Tyler Research Institute, LLC
Tyler, Texas, 75701
- Recruiting
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, 15401-9069
- Recruiting
The Vancouver Clinic
Vancouver, Washington, 98664
- Recruiting
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, 44145
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
- Recruiting
Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas, 67226
- Recruiting
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
Williamsburg, Virginia, 23188
- Recruiting
Florida Medical Clinic - Orlando Health
Zephyrhills, Florida, 33542
Japan50 sites, 49 recruiting
- Recruiting
Gamagori City Hospital
Aichi, 443-8501
- Recruiting
Nagoya City University Hospital
Aichi, 467-8602
- Recruiting
National Hospital Organization Hirosaki General Medical Center
Aomori, 036-8545
- Recruiting
Asahikawa Medical University Hospital
Asahikawa-shi, Hokkaido, 078-8510
- Recruiting
Asahikawa City Hospital
Asahikawa-shi, 070-8610
- Recruiting
Tsujinaka Hospital Kashiwanoha
Chiba, 277-0871
- Recruiting
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502
- Recruiting
Ehime Prefectural Central Hospital
Ehime, 790-0024
- Recruiting
Fukui Prefectural Hospital
Fukui, 910-8526
- Recruiting
Kitakyushu Municipal Medical Center
Fukuoka, 802-8561
- Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563
- Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
- Recruiting
Fukuoka University Hospital
Fukuoka, 814-0180
- Recruiting
Kurume University Hospital
Fukuoka, 830-0011
- Recruiting
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
- Recruiting
Hiroshima University Hospital
Hiroshima, 734-8551
- Recruiting
Sapporo Kosei General Hospital
Hokkaido, 060-0033
- Recruiting
Sapporo Medical University Hospital
Hokkaido, 060-8543
- Recruiting
Medical Corporation Sapporo IBD Clinic
Hokkaido, 064-0919
- Recruiting
Hyogo Medical University Hospital
Hyōgo, 663-8501
- Recruiting
Ishikawa Prefectural Central Hospital
Ishikawa, 920-8530
- Recruiting
Kagawa Prefectural Central Hospital
Kagawa, 760-8557
- Recruiting
Sameshima Hospital
Kagoshima, 892-0846
- Recruiting
Yokohama City University Medical Center
Kanagawa, 232-0024
- Recruiting
Gokeikai Ofuna Chuo Hospital
Kanagawa, 247-0056
- Recruiting
Japanese Red Cross Kumamoto Hospital
Kumamoto, 861-8520
- Recruiting
Sendai Kousei Hospital
Miyagi, 981-0914
- Recruiting
Sendai Medical Center
Miyagi, 983-8520
- Recruiting
Nagasaki University Hospital
Nagasaki, 852-8501
- Recruiting
Okayama University Hospital
Okayama, 700-8558
- Withdrawn
Kinshukai Infusion Clinic
Osaka, 530-0011
- Recruiting
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
- Recruiting
Saga-ken Medical Centre Koseikan
Saga, 840-8571
- Recruiting
Saga University Hospital
Saga, 849-8501
- Recruiting
Takagi clinic
Sendai, Miyagi, 981-3213
- Recruiting
National Hospital Organization Shizuoka Medical Center
Shizuoka, 411-8611
- Recruiting
Hamamatsu University Hospital
Shizuoka, 431-3192
- Recruiting
Matsuda Hospital
Shizuoka, 432-8061
- Recruiting
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
- Recruiting
The Jikei University Hospital
Tokyo, 105-8471
- Recruiting
Institute of Science Tokyo Hospital
Tokyo, 113-8519
- Recruiting
Tokyo Metropolitan Bokutoh Hospital
Tokyo, 130-8575
- Recruiting
Keio University Hospital
Tokyo, 160-8582
- Recruiting
National Center for Global Health and Medicine
Tokyo, 162-0052
- Recruiting
JCHO Tokyo Yamate Medical Center
Tokyo, 169-0073
- Recruiting
Kyorin University Hospital
Tokyo, 181-8611
- Recruiting
Toyama University Hospital
Toyama, 930-0194
- Recruiting
Japanese Red Cross Wakayama Medical Center
Wakayama, 640-8558
- Recruiting
Yamagata University Hospital
Yamagata, 990-9585
- Recruiting
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506
China25 sites, 25 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
- Recruiting
the First Hospital of Jilin University
Changchun, 130021
- Recruiting
Third Xiangya Hospital Centrel South University
Changsha, 410013
- Recruiting
West China Hospital of Sichuan University
Chengdu, 610041
- Recruiting
Chongqing General Hospital
Chongqing, 401147
- Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005
- Recruiting
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260
- Recruiting
The sixth affiliated hospital of Sun Yat-Sen University
Guangzhou, 510655
- Recruiting
Zhejiang Province Traditional Chinese Medical Hospital
Hangzhou, 310006
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, 310016
- Recruiting
Anhui Provincial Hospital
Hefei, 230001
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
- Recruiting
Huizhou Central People's Hospital
Huizhou, 516001
- Recruiting
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006
- Recruiting
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021
- Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, 315000
- Recruiting
Shanghai East Hospital
Shanghai, 200126
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, 518036
- Recruiting
Taizhou Hospital Of Zhejiang Province
Taizhou, 318050
- Recruiting
The Central Hospital of Wuhan
Wuhan, 430014
- Recruiting
Ren Min Hospital Affiliated Wu Han University
Wuhan, 430060
- Recruiting
Wuxi People's Hospital
Wuxi, 214023
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, 361004
- Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
- Recruiting
Zhuzhou Central Hospital
Zhuzhou, 412007
Poland23 sites, 23 recruiting
- Recruiting
SPZOZ w ??cznej
??czna, 21-010
- Recruiting
Clinical Trials UMED Sp. z o. o.
?ód?, 92-213
- Recruiting
Uniwersytecki Szpital Kliniczny W Bia?Ymstoku
Bia?ystok, 15-276
- Recruiting
Centrum Medyczne "Medis"
Bydgoszcz, 85-229
- Recruiting
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
Chojnice, 89-600
- Recruiting
Endo-Med Sp. z o.o.
Karczew
- Recruiting
Centrum Medyczne Plejady
Krakow, 30-363
- Recruiting
Krakowskie Centrum Medyczne - Part of Futuremeds
Krakow, 31-501
- Recruiting
Allmedica Badania Kliniczne Sp z o.o. Sp K.
Nowy Targ, 34-400
- Recruiting
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn, 10-561
- Recruiting
NZOZ Eskulap Pabianice
Pabianice, 95-200
- Recruiting
Trialmed CRS
Piotrkow Trybunalski, 97-300
- Recruiting
SOLUMED Centrum Medyczne
Późna, 60-529
- Recruiting
Centrum Medyczne "MEDYK"
Rzeszów, 35-326
- Recruiting
Nowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
Staszów, 20-200
- Recruiting
Gastromed Sp. z o.o.
Toru?, 87-100
- Recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
- Recruiting
Centralny Szpital Kliniczny MSW w Warszawie
Warsaw, 02-507
- Recruiting
Melita Medical
Wroc?aw, 50-449
- Recruiting
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
Wroc?aw, 53-149
- Recruiting
Penta Hospitals Przychodnie, Wroclaw Wejherowska
Wroc?aw, 54-239
- Recruiting
Centrum Medyczne Oporow
Wroclaw, 52-416
- Recruiting
ETG Zamosc
Zamość, 22-400
Italy17 sites, 17 recruiting
- Recruiting
A.O. Universitaria Ospedale Consorziale Policlinico Di Bari
Bari, Apulia, 70124
- Recruiting
Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro
Catanzaro, Calabria, 88100
- Recruiting
A.O.U Careggi
Florence, Tuscany, 50124
- Recruiting
ASST Fatebenefratelli-Sacco, Polo "Ospedale Fatebenefratelli ed oftalmico"
Milan, Lombardy, 20121
- Recruiting
Asst Santi Paolo E Carlo
Milan, Lombardy, 20142
- Recruiting
Azienda Ospedaliero - Universitaria di Cagliari
Monserrato, Sardinia, 09042
- Recruiting
Azienda Ospedaliera San Gerardo di Monza
Monza MI, Lombardy, 20900
- Recruiting
Universita'degli Studi di Napoli Federico II
Naples, Campania, 80131
- Recruiting
Azienda Ospedaliera di Padova
Padova, Veneto, 35128
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Lombardy, 27100
- Recruiting
ASST Rhodense - Ospedale di Rho
Rho, Lombardy, 20017
- Recruiting
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00151
- Recruiting
Ospedale Sandro Pertini
Rome, Lazio, 00157
- Recruiting
Ospedale Isola Tiberina Gemelli
Rome, Lazio, 00186
- Recruiting
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, 20089
- Recruiting
IRCCS Ospedale Casa Sollievo della Soffenza
San Giovanni Rotondo, Lombardy, 71013
- Recruiting
Ospedale Mauriziano Umberto I
Turin, Piedmont, 10128
India13 sites, 12 recruiting
- Recruiting
AIG Hospitals
Gachibowli, Telangana, 500032
- Recruiting
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302006
- Recruiting
SMS Superspeciality Hospital
Jaipur, Rajasthan, 302007
- Recruiting
Amrita Institute of Medical Sciences
Kochi, Kerala, 682041
- Recruiting
Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
Kolkata, West Bengal, 700020
- Recruiting
Kurnool Medical College
Kurnool, Andhra Pradesh, 518002
- Recruiting
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, 440018
- Recruiting
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110029
- Withdrawn
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005
- Recruiting
Gandhi Hospital
Secunderabad, Telangana, 500003
- Recruiting
Yashoda Hospitals
Secunderabad, Telangana, 500003
- Recruiting
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, 395002
- Recruiting
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, 395009
South Korea12 sites, 12 recruiting
- Recruiting
Inje university Haeundae Paik Hospital
Busan, 48108
- Recruiting
Dong-A University Hospital
Busan, 49201
- Recruiting
Kyungpook National University Hospital
Daegu, 41944
- Recruiting
The Catholic University of Korea Daejeon ST. Mary?s Hospital
Daejeon, 34943
- Recruiting
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, 26426
- Recruiting
Hanyang University Guri Hospital
Guri-si, 11923
- Recruiting
Kyung Hee University Hospital
Seoul, 02447
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
Chung-Ang University Hospital
Seoul, 06973
- Recruiting
Ewha Womans University Hospital (Seoul)
Seoul, 07804
Australia10 sites, 10 recruiting
- Recruiting
Flinders Medical Center
Adelaide, South Australia, 5042
- Recruiting
Lyell McEwin Hospital
Adelaide, South Australia, 5112
- Recruiting
Northern Hospital
Epping, Victoria, 3076
- Recruiting
The Canberra Hospital
Garran, Australian Capital Territory, 2605
- Recruiting
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
- Recruiting
Mater Misericordiae Limited
South Brisbane, Queensland, 4101
- Recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Belgium10 sites, 7 recruiting
- Recruiting
AZORG Campus Aalst-Moorselbaan
Aalst, 9300
- Withdrawn
Cliniques Universitaires St-Luc
Brussels, 1200
- Recruiting
UZ Antwerpen
Edegem, 2650
- Recruiting
AZ Maria Middelares
Ghent, 9000
- Recruiting
AZ Sint Lucas (Sint Lucas)
Ghent, 9000
- Withdrawn
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
- Withdrawn
CHC MontLégia
Liège, 4000
- Recruiting
CHU de Liège (Sart Tilman)
Liège, 4000
- Recruiting
CHU HELORA - Hôpital de Mons - Site Kennedy
Mons, 7000
- Recruiting
Vitaz
Sint-Niklaas, 9100
Brazil8 sites, 8 recruiting
- Recruiting
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970
- Recruiting
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
Brasília, Federal District, 70200-730
- Recruiting
Centro de Pesquisa São Lucas
Campinas, São Paulo, 13060-904
- Recruiting
Centro Digestivo de Curitiba
Curitiba, Paraná, 80430-160
- Recruiting
Hospital de Clinicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul, 90035-903
- Recruiting
CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, Estado de Bahia, 41500-300
- Recruiting
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, 01228-000
- Recruiting
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, 03325-050
Germany8 sites, 4 recruiting
- Recruiting
Charite - Campus Benjamin Franklin
Berlin, 12203
- Withdrawn
AGAPLESION Markus-Krankenhaus
Frankfurt, 60431
- Withdrawn
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, 60590
- Recruiting
Universitaetsklinikum Halle (Saale)
Halle, 06120
- Withdrawn
Med. Hochschule Hannover
Hanover, 30625
- Recruiting
Universitaetsklinikum Jena
Jena, 77430
- Withdrawn
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167
- Recruiting
Universitätsklinikum Ulm
Ulm, 89081
United Kingdom8 sites, 7 recruiting
- Recruiting
Addenbrookes Hospital
Cambridge, CB2 0QQ
- Recruiting
St Mark's Hospital & Imperial College
Harrow, HA1 3UJ
- Recruiting
Royal Liverpool University Hospital
Liverpool, L7 8XP
- Recruiting
King College Hospital NHS Foundation Trust
London, SE5 9RS
- Withdrawn
Queen Anne Street Medical Centre
London, W1T 6AH
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
- Recruiting
North Tyneside General Hospital
North Shields, NE29 8NH
- Recruiting
Nottingham University Hospitals Queen's Medical Centre
Nottingham, NG7 2UH
France7 sites, 7 recruiting
- Recruiting
CHU Amiens - Hopital Sud
Amiens, 80054
- Recruiting
Hopital Nord
Marseille, 13015
- Recruiting
CHU Nice - Hopital de l'Archet 2
Nice, 06202
- Recruiting
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604
- Recruiting
Hopital Robert Debre
Reims, 51092
- Recruiting
CHU de Rennes - Hopital de Pontchaillo
Rennes, 35033
- Recruiting
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, 42055
Hungary7 sites, 7 recruiting
- Recruiting
Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
Békéscsaba, 5600
- Recruiting
Obudai Egeszsegugyi Centrum Kft.
Budapest, 1036
- Recruiting
Semmelweis Egyetem
Budapest, 1088
- Recruiting
Pannonia Maganorvosi Centrum
Budapest, 1136
- Recruiting
Clinexpert Gyongyos Kft
Gyöngyös, 3200
- Recruiting
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
Székesfehérvár, 8000
- Recruiting
Clinfan Szolgaltato Kft.
Szekszárd, 7100
Serbia6 sites, 6 recruiting
- Recruiting
University Hospital Center Dr Dragisa Misovic - Dedinje
Belgrade, 11040
- Recruiting
Clinical Hospital Center Zemun
Belgrade, 11080
- Recruiting
University Hospital Medical Center Bezanijska Kosa
Belgrade, 11080
- Recruiting
University Hospital Medical Center Zvezdara
Belgrade, 11120
- Recruiting
Clinical Center of Vojvodina
Novi Sad, 21137
- Recruiting
General Hospital "Djordje Joanovic"
Zrenjanin, 23000
Spain6 sites, 4 recruiting
- Recruiting
Hospital de Galdakao
Galdacao, Vizcaya, 48960
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitario Reina Sofía
Murcia, 30003
- Withdrawn
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
- Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026
- Withdrawn
Hospital Universitario Rio Hortega
Valladolid, 47012
Bulgaria5 sites, 5 recruiting
- Recruiting
MBAL Burgasmed
Burgas, 8011
- Recruiting
MHAT St. Ivan Rilski
Gorna Oryahovitsa, 5100
- Recruiting
Futuremeds Medical Center
Plovdiv, 4000
- Recruiting
MHAT Saint Karidad EAD
Plovdiv, 4000
- Recruiting
Tokuda Hospital
Sofia, 1407
Portugal5 sites, 5 recruiting
- Recruiting
Hospital de Braga
Braga, 4710-243
- Recruiting
Hospital de Santa Maria
Lisbon, 1649-035
- Recruiting
Hospital de Sao Joao
Porto, 4202-451
- Recruiting
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, 4520-211
- Recruiting
Hospital Sao Teotonio
Viseu, 3504-509
Thailand5 sites, 5 recruiting
- Recruiting
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
Bangkok, 10330
- Recruiting
Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
Bangkok, 10700
- Recruiting
Khon Kaen Uni
Khon Kaen, 40002
- Recruiting
Thammasat University Hospital
Pathum Thani, 12120
- Recruiting
Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
Songkhla, 90110
Austria4 sites, 4 recruiting
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, 6020
- Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
- Recruiting
Barmherzige Brüder Wien
Vienna, 1020
- Recruiting
Medizinische Universität Wien
Vienna, 1090
Colombia4 sites, 4 recruiting
- Recruiting
Clinica del Country
Bogotá, 11001
- Recruiting
Clinica Colsanitas S.A. sede Clinica Universitaria Colombia
Bogota, D.C., 111321
- Recruiting
Hospital Pablo Tobon Uribe
Medellín, 050034
- Recruiting
IPS Salud SURA Portal del Genovés
Puerto Colombia, 080001
Czechia4 sites, 4 recruiting
- Recruiting
SurGal Clinic s.r.o.
Brno, 602 00
- Recruiting
Nemocnice Ceske Budejovice a.s.
České Budějovice, 370 01
- Recruiting
Gastroenterologie s.r.o.
Hradec Králové, 500 02
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
Israel4 sites, 4 recruiting
- Recruiting
Soroka University Medical Centre
Beersheba, Negev, 84101
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, 5265601
Netherlands4 sites, 2 recruiting
- Withdrawn
Ziekenhuis Rijnstate
Arnhem, 6815 AD
- Withdrawn
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG
- Recruiting
ETZ Elisabeth
Tilburg, 5022 GC
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Slovakia4 sites, 4 recruiting
- Recruiting
Cliniq s.r.o.
Bratislava, 811 09
- Recruiting
Nemocnica Bory -Penta Hospitals
Bratislava, 841 03
- Recruiting
Endomed, s.r.o.
Košice, 040 01
- Recruiting
Ustredna vojenska nemocnica SNP Ruzomberok ? FN
Ružomberok, 034 26
Taiwan4 sites, 4 recruiting
- Recruiting
E-Da Hospital
Kaohsiung City, 82445
- Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
- Recruiting
China Medical University Hospital
Taichung, 40447
- Recruiting
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
United Arab Emirates4 sites, 4 recruiting
- Recruiting
Sheikh Shakhbout Medical City
Abu Dhabi, 11001
- Recruiting
Sheikh Khalifa Medical City (SKMC)
Abu Dhabi, 51900
- Recruiting
Burjeel Hopital
Abu Dhabi, 7400
- Recruiting
Rashid Hospital
Dubai, 4545
Canada3 sites, 2 recruiting
- Recruiting
South Edmonton Gastroenterology
Edmonton, Alberta, T6K 4B2
- Withdrawn
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1
- Recruiting
TDDA Specialty Research
Vaughan, Ontario, L4L 4Y7
Chile3 sites, 3 recruiting
- Recruiting
Hospital Guillermo Grant Benavente
Concepción, 4030000
- Recruiting
Medwal
Santiago, 7500000
- Recruiting
Clinica Universidad de Los Andes
Santiago
Mexico3 sites, 3 recruiting
- Recruiting
Boca Clinical Trials Mexico S.C. (Guadalajara)
Guadalajara, Jalisco, 44600
- Recruiting
Medical Care & Research SA de CV
Mérida, Yucatán, 97000
- Recruiting
Hospital General de Mexico
Mexico, Tlaxcala, 06726
Argentina2 sites, 2 recruiting
- Recruiting
Hospital Britanico
Ciudad Autonoma Bs As, C1280AEB
- Recruiting
Hospital Provincial del Centenario
Rosario, S2002KDS
Croatia2 sites, 2 recruiting
- Recruiting
Borzan Polyclinic
Osijek, 31000
- Recruiting
Clinical Hospital Centre Zagreb
Zagreb, 10000
Guatemala2 sites, 2 recruiting
- Recruiting
Celan S.A.
Guatemala City, 01010
- Recruiting
Medi-k
Guatemala City, 01016
Panama2 sites, 2 recruiting
- Recruiting
Gastroenterólogos y Asociados
Panama City, 07192
- Recruiting
Instituto de Investigación e Innovación y Gestión del Conocimiento (III-GC)
Panama City, 0801
Puerto Rico2 sites, 2 recruiting
- Recruiting
Klinical Investigations Group LLC
San Juan, 00909
- Recruiting
University of Puerto Rico Medical Sciences Campus
San Juan, 00936-5067
Romania2 sites, 2 recruiting
- Recruiting
Colentina Clinical Hospital
Bucharest, 020125
- Recruiting
Cantacuzino Clinical Hospital
Bucharest, 020475
Dominican Republic1 site, 1 recruiting
- Recruiting
CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)
Santo Domingo, 10134
About this study
Official title: 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
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).
- Being tested
- Afimkibart, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfimkibartDrug
Also called PF-06480605, RVT-3101, RG6631, RO7790121
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
PlaceboDrug
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Afimkibart | Experimental | Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. Receives: Drug: Afimkibart |
| Arm 2: Afimkibart | Experimental | Participants will receive afimkibart IV followed by afimkibart SC injection. Receives: Drug: Afimkibart |
| Arm 3: Placebo | Placebo comparator | Participants will receive placebo IV followed by placebo SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At Week 52
Secondary outcomes (28)
Percentage of Participants with Clinical Remission
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.
Measured: At Week 12
Percentage of Participants with Endoscopic Response
Percentage of participants achieving a decrease in 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.
Measured: At Week 12
Percentage of Participants with Symptomatic Remission
Percentage of participants with the daily number of liquid or very soft stools <=2.8 and the average of daily abdominal pain scores in the past week <=1, with neither being greater than baseline.
Measured: At Week 12
Percentage of Participants with Endoscopic Remission
Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline >=2 and no subscore >1.
Measured: At Week 12
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Measured: At Week 12
Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)
Daily average number of liquid or very soft stools over 7 days.
Measured: Baseline through Week 12
Average of Daily Abdominal Pain Scores in the Past Week (APS)
The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.
Measured: Baseline through Week 12
Percentage of Participants with Endoscopic Remission
Percentage of participants with SES-CD=0 to 4 with decrease from baseline >=2 and no subscore >1 .
Measured: At Week 52
Percentage of Participants with Symptomatic Remission
Percentage of participants with the daily number of liquid or very soft stools <=2.8 and the average of daily abdominal pain scores in the past week <=1, with neither being greater than baseline.
Measured: At Week 52
Percentage of Participants with Corticosteroid-free Clinical Remission
Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.
Measured: At Week 52
Maintenance of Clinical Remission
Percentage of participants with clinical remission at both Weeks 12 and 52.
Measured: At Weeks 12 and 52
Maintenance of Endoscopic Response
Percentage of participants with endoscopic response at both Weeks 12 and 52.
Measured: At Weeks 12 and 52
Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52
Percentage of participants achieving a CDAI score of <150 and SES-CD of 0 to 4 with a decrease from baseline >=2 and no subscore >1 at Week 52.
Measured: At Week 52
Percentage of Participants with Ulcer-free Endoscopy
Percentage of participants with an SES-CD ulcerated surface subscore of 0.
Measured: At Week 52
Bowel Urgency
Bowel urgency from baseline through week 12 and week 52. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from "None" to "Severe."
Measured: Baseline through Week 12 and Week 52
Fatigue
Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from "Not at all" to "Very much."
Measured: Baseline to Week 12 and Week 52
Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Change in IBDQ score from baseline to week 12 and 52. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.
Measured: Baseline to Week 12 and Week 52
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a CDAI score of <150 at Week 12 in biomarker-defined subgroups. 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.
Measured: At Week 12
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a CDAI score of <150 at Week 52 in biomarker-defined subgroups. 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.
Measured: At Week 52
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a decrease in 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.
Measured: At Week 12
Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants
Percentage of participants achieving a decrease in 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.
Measured: At Week 52
Percentage of Participants with Clinical Response
Percentage of participants with a decrease >=100 in CDAI from baseline.
Measured: At Week 12
Percentage of Participants with Symptomatic Response
Percentage of participants with a decrease >=30% in both SF and APS, with neither being greater than baseline.
Measured: At Week 12
Overall Change in CD Symptoms
Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from "Much better" to "Much worse".
Measured: Baseline to Weeks 2, 6, 12 and 52
Overall Severity in CD Symptoms
Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52. PGIS measures severity of Crohn's disease symptoms from "None" to "Very severe".
Measured: Baseline to Weeks 2, 6, 12 and 52
Change in General Well-being
The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.
Measured: Baseline through Week 52
Incidence and Severity of Adverse Events (AEs)
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.
Measured: Up to 70 Weeks after Baseline
Percentage of Participants with a Presence of Draining Fistulas
Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.
Measured: Baseline through Week 12 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Mar 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderately to Severely Active Crohns DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819878
- Sponsor's protocol ID
- GA45331
- Other IDs
- 2024-513053-69-00
- Acronym
- SIBERITE-1
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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