A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT06588855
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
350 participants
INTERVENTIONAL
2024-12-11
2029-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Placebo
Participants will receive placebo IV followed by placebo SC.
Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Interventions
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Afimkibart
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Placebo
Placebo matching IV afimkibart. Placebo matching SC afimkibart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately to severely active UC assessed by mMS
* Bodyweight \>= 40 kilogram (kg)
* Up to date with colorectal cancer (CRC) screening performed according to local standards
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria
* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell 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)
* 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
16 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Mayo Clinic Hospital
Scottsdale, Arizona, United States
Arizona Digestive Health, P.C (ADH)
Sun City, Arizona, United States
Om Research LLC
Apple Valley, California, United States
Valley View Internal Medicine
Garden Grove, California, United States
Gastro Care Associates
Lancaster, California, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States
The Sister Life Research
Hialeah, Florida, United States
LCC Medical Research Institute, LLC
Miami, Florida, United States
Ambert Medical Research
Miami, Florida, United States
Gastroenterology Institute of Orlando
Orlando, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
University of South Florida School of Medicine Morsani Center for Advanced Health Care
Tampa, Florida, United States
Guardian Angel Research Center, LLC
Tampa, Florida, United States
Santos Research Center, CORP
Tampa, Florida, United States
Randomize Now, LLC
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States
Illinois Gastroenterology Group-Glenview powered by GI Alliance
Glenview, Illinois, United States
GI Alliance - Gurnee
Gurnee, Illinois, United States
Gastro Health Partners, LLC
New Albany, Indiana, United States
Kansas Gastroenterology, LLC under Clinical Trials Network
Wichita, Kansas, United States
One GI: GHP - Gastroenterology Health Partners Louisville
Louisville, Kentucky, United States
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States
Delta Gastroenterology & Endoscopy Center
Southaven, Mississippi, United States
Ellipsis Research Group
Brooklyn, New York, United States
Weill Cornell Medical College
New York, New York, United States
DiGiovanna Inst for Med Ed&Res
North Massapequa, New York, United States
Queens Village Medical Care
Queens Village, New York, United States
Gastroenterology Group Of Rochester, LLP
Rochester, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
Omega Research North Carolina, LLC
Fuquay-Varina, North Carolina, United States
Dayton Gastroenterology, Inc.
Beavercreek, Ohio, United States
University of Cincinnati Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Gastroenterology Group
Columbus, Ohio, United States
Ohio State University
Hilliard, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio
Westlake, Ohio, United States
Frontier Clinical Re search, LLC
Uniontown, Pennsylvania, United States
Gastroenterology Associates
Greenville, South Carolina, United States
Gastro One
Cordova, Tennessee, United States
Uni of Texas Medical Branch
Galveston, Texas, United States
Amel Med LLC
Georgetown, Texas, United States
Cano Medical Center
Harlingen, Texas, United States
Texas Digestive Specialists
Harlingen, Texas, United States
Integrity Advanced Therapeutics PLLC
Houston, Texas, United States
Southern Star Research Institute, LLC.
San Antonio, Texas, United States
Baylor Scott and White Medical Center
Temple, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, United States
Gastroenterology Consultants of SWVA
Roanoke, Virginia, United States
Hospital Britanico
Ciudad Autonoma Bs As, , Argentina
Instituto Medico CER
Quilmes, , Argentina
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Coral Sea Clinical Research Institute
Mackay, Queensland, Australia
Footscray Hospital
Footscray, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Ordensklinikum Linz Barmherzige Schwestern
Linz, , Austria
Klinikum Wels-Grieskirchen
Wels, , Austria
AZORG Campus Aalst-Moorselbaan
Aalst, , Belgium
CHU St Pierre (St Pierre)
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
AZ Oostende
Ostend, , Belgium
Instituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Newdata Clinical Trials
Aracaju, Sergipe, Brazil
CECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
Centro Paulista de Investigacao Clinica - CEPIC
São Paulo, São Paulo, Brazil
Second Multiprofile Hospital For Active Treatment-Sofia
Sofia Town, Sofia, Bulgaria
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, , Bulgaria
"City Clinic UMHAC" EOOD
Sofia, , Bulgaria
Barrie GI Associates
Barrie, Ontario, Canada
GNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada
London Health Sciences Centre Uni Campus
London, Ontario, Canada
TIDHI Innovation Inc.
Toronto, Ontario, Canada
CIUSSS-de-l?Est-de-l?Île-de-Montréal
Montreal, Quebec, Canada
Centro de Investigación Clínica UC-CICUC
Santiago, , Chile
Beijing No.6 Hospital
Beijing, Beijing Municipality, China
The First Affilliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Third Xiangya Hospital Centrel South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
Guangzhou First People's Hospital
Guangzhou, , China
The second Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou, , China
Huizhou Central People's Hospital
Huizhou, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
The First Affiliate Hospital of Guangxi Medical University
Nanning, , China
The First Affiliated Hospital of Ningbo University
Ningbo, , China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, , China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
First Affiliated Hospital of Soochow University
Suzhou, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Zhongshan Hospital Xiamen University
Xiamen, , China
Borzan Polyclinic
Osijek, , Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
ISCARE a.s.
Prague, , Czechia
Ålborg Universitets Hospital
Aalborg, , Denmark
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
CHU Clermont Ferrand - Hôtel Dieu
Clermont-Ferrand, , France
Hôpital Henri Mondor
Créteil, , France
Polyclinique Grand Sud
Nîmes, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Medizinisches Zentrum Klinikum Lueneburg
Lüneburg, , Germany
Klinikum Ernst von Bergmann
Potsdam, , Germany
Észak-Pesti Centrumkórház-Honvédkórház
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
Debrecen, , Hungary
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
Székesfehérvár, , Hungary
Vas-Oxy Egeszsegugyi Kft
Szombathely, , Hungary
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, India
Gujarat Gastro and Vascular Hospital
Surat, Gujarat, India
MIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, India
Sahyadri Super Speciality Hospital
Nashik, Maharashtra, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
SMS Superspeciality Hospital
Jaipur, Rajasthan, India
AIG Hospitals
Gachibowli, Telangana, India
Yashoda Hospitals
Secunderabad, Telangana, India
Soroka Medical Center
Beersheba, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, Italy
Ospedale Isola Tiberina Gemelli
Rome, Lazio, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza MI, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano (MI), Lombardy, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, Italy
Boca Clinical Trials Mexico S.C. (Cd. Mexico)
Miguel Hidalgo, Mexico CITY (federal District), Mexico
FAICIC S de R.L. de C.V
Veracruz, , Mexico
ETZ Elisabeth
Tilburg, , Netherlands
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
?ód?, , Poland
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, , Poland
Medical Center Kermed
Bydgoszcz, , Poland
Szpital Miejski sw. Jana Paw?a II w Elblagu
Elblag, , Poland
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska
Grudzadz, , Poland
Osrodek Badan Klinicznych Bd Research
I?awa, , Poland
MZ Badania Slowik Zymla Sp.j.
Knurów, , Poland
Centrum Medyczne Promed
Krakow, , Poland
Medrise sp z o.o
Lublin, , Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Poznan, , Poland
EMC Instytut Medyczny SA
Późna, , Poland
Gabinety Lekarskie Rivermed
Późna, , Poland
Endoskopia Sp. z o.o.
Sopot, , Poland
Sonomed Sp. z o.o.
Szczecin, , Poland
Centrum Zdrowia-MDM
Warsaw, , Poland
Medon Clinical Research sp. z o.o
Warsaw, , Poland
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
Warsaw, , Poland
PlanetMed sp. z o.o.
Wroc?aw, , Poland
Centrum Medyczne Oporow
Wroclaw, , Poland
Hospital de Braga
Braga, , Portugal
Hospital da Luz Lisboa
Lisbon, , Portugal
Centro Hospitalar do Algarve - Hospital de Portimao
Portimão, , Portugal
Hospital de Sao Joao
Porto, , Portugal
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, , Portugal
Hospital Sao Teotonio
Viseu, , Portugal
Klinical Investigations Group LLC
San Juan, , Puerto Rico
General Hospital "Djordje Joanovic"
Zrenjanin, , Serbia
KM Management spol. s r.o.
Nitra, , Slovakia
Accout Center s.r.o.
Šahy, , Slovakia
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Clinico Univ. Lozano Blesa
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
China Medical University Hospital
Taichung, , Taiwan
Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
Chiang Mai, , Thailand
Burapha University Hospital
Chon Buri, , Thailand
Sunpasitthiprasong Hospital
Ubonratchathani, , Thailand
Leicester General Hospital
Leicester, , United Kingdom
Bronglais General Hospital
Llanrhystud, , United Kingdom
King College Hospital NHS Foundation Trust
London, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: GA45330 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
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2024-513015-27-00
Identifier Type: OTHER
Identifier Source: secondary_id
GA45330
Identifier Type: -
Identifier Source: org_study_id