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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

NCT06588855 · Hoffmann-La Roche
In plain English

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Official title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
About this study
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Eligibility criteria
Inclusion Criteria: * Confirmed diagnosis of UC * 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: * Currently known complications of UC (e.g. fulminant colitis, toxic megacolon) * 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
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: double
Age groups: child, adult, older_adult
Timeline
Starts: 2024-12-11
Estimated completion: 2031-01-30
Last updated: 2026-04-02
Interventions
Drug: AfimkibartDrug: Placebo
Primary outcomes
  • Percentage of Participants with Clinical Remission (At Week 12)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: GA45330 https://forpatients.roche.com/ · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. and Canada)
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (198)
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - DothanRecruiting
Dothan, Alabama, United States
Mayo Clinic HospitalRecruiting
Scottsdale, Arizona, United States
Arizona Digestive Health, P.C (ADH)Recruiting
Sun City, Arizona, United States
Om Research LLCRecruiting
Apple Valley, California, United States
Valley View Internal MedicineRecruiting
Garden Grove, California, United States
Gastro Care AssociatesRecruiting
Lancaster, California, United States
University of Southern CaliforniaRecruiting
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and EducationRecruiting
Newport Beach, California, United States
Stanford Medicine Outpatient CenterRecruiting
Redwood City, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Hi Tech and Global Research, LLCRecruiting
Coral Gables, Florida, United States
The Sister Life ResearchRecruiting
Hialeah, Florida, United States
LCC Medical Research Institute, LLCRecruiting
Miami, Florida, United States
Allied Biomedical Research InstituteRecruiting
Miami, Florida, United States
Ambert Medical ResearchWithdrawn
Miami, Florida, United States
Integrity Trials LLCRecruiting
Orlando, Florida, United States
Digestive and Liver Center of FloridaRecruiting
Orlando, Florida, United States
Advanced Medical Research CenterRecruiting
Port Orange, Florida, United States
University of South Florida School of Medicine Morsani Center for Advanced Health CareRecruiting
Tampa, Florida, United States
Guardian Angel Research Center, LLCRecruiting
Tampa, Florida, United States
Santos Research Center, CORPRecruiting
Tampa, Florida, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
Randomize Now, LLCRecruiting
Atlanta, Georgia, United States
Atlanta Gastroenterology AssociatesRecruiting
Atlanta, Georgia, United States
Gastroenterology Associates of Central GeorgiaRecruiting
Macon, Georgia, United States
Grand Teton Research Group, PLLCRecruiting
Idaho Falls, Idaho, United States
Illinois Gastroenterology Group-Glenview powered by GI AllianceRecruiting
Glenview, Illinois, United States
GI Alliance - GurneeRecruiting
Gurnee, Illinois, United States
Gastro Health Partners, LLCRecruiting
New Albany, Indiana, United States
Kansas Gastroenterology, LLC under Clinical Trials NetworkRecruiting
Wichita, Kansas, United States
One GI: GHP - Gastroenterology Health Partners LouisvilleRecruiting
Louisville, Kentucky, United States
Louisiana Research Center - GastroIntestinal AssociatesRecruiting
Shreveport, Louisiana, United States
Allied Gastrointestinal Associates, PARecruiting
Flowood, Mississippi, United States
Delta Gastroenterology & Endoscopy CenterRecruiting
Southaven, Mississippi, United States
Ellipsis Research GroupRecruiting
Brooklyn, New York, United States
NYU Inflammatory Bowel Disease CenterRecruiting
New York, New York, United States
Weill Cornell Medical CollegeRecruiting
New York, New York, United States
DiGiovanna Inst for Med Ed&ResRecruiting
North Massapequa, New York, United States
Queens Village Medical CareRecruiting
Queens Village, New York, United States
Gastroenterology Group Of Rochester, LLPRecruiting
Rochester, New York, United States
James J Peters Veterans Administration Medical Center - NAVREFRecruiting
The Bronx, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.CRecruiting
Charlotte, North Carolina, United States
Omega Research North Carolina, LLCRecruiting
Fuquay-Varina, North Carolina, United States
Peters Medical Research (PMR), LLCRecruiting
High Point, North Carolina, United States
Dayton Gastroenterology, Inc.Recruiting
Beavercreek, Ohio, United States
University of Cincinnati HospitalRecruiting
Cincinnati, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Ohio Gastroenterology GroupRecruiting
Columbus, Ohio, United States
Ohio State UniversityRecruiting
Columbus, Ohio, United States
Gastro Intestinal Research Institute of Northern OhioRecruiting
Westlake, Ohio, United States
Frontier Clinical Re search, LLCRecruiting
Uniontown, Pennsylvania, United States
University GastroenterologyRecruiting
Providence, Rhode Island, United States
Gastroenterology AssociatesRecruiting
Greenville, South Carolina, United States
Gastro OneRecruiting
Cordova, Tennessee, United States
Uni of Texas Medical BranchRecruiting
Galveston, Texas, United States
GI AllianceRecruiting
Garland, Texas, United States
Amel Med LLCRecruiting
Georgetown, Texas, United States
Cano Medical CenterRecruiting
Harlingen, Texas, United States
Texas Digestive SpecialistsRecruiting
Harlingen, Texas, United States
Integrity Advanced Therapeutics PLLCNot Yet Recruiting
Houston, Texas, United States
GI Alliance - Bay Area GastroenterologyRecruiting
Lubbock, Texas, United States
TDDC dba GI Alliance ResearchNot Yet Recruiting
Mansfield, Texas, United States
Southern Star Research Institute, LLC.Recruiting
San Antonio, Texas, United States
Baylor Scott and White Medical CenterRecruiting
Temple, Texas, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
University of Texas Health Center at TylerRecruiting
Tyler, Texas, United States
TDDC GI Alliance research WebsterRecruiting
Webster, Texas, United States
Gastroenterology Associates of TidewaterRecruiting
Chesapeake, Virginia, United States
Emeritas Research GroupRecruiting
Lansdowne Town Center, Virginia, United States
Gastroenterology Consultants of SWVARecruiting
Roanoke, Virginia, United States
Hospital BritanicoRecruiting
Ciudad Autonoma Bs As, Argentina
Instituto Medico CERRecruiting
Quilmes, Argentina
Macquarie University HospitalRecruiting
Macquarie Park, New South Wales, Australia
Coral Sea Clinical Research InstituteRecruiting
Mackay, Queensland, Australia
Footscray HospitalRecruiting
Footscray, Victoria, Australia
Royal Melbourne HospitalRecruiting
Parkville, Victoria, Australia
Ordensklinikum Linz Barmherzige SchwesternActive Not Recruiting
Linz, Austria
Klinikum Wels-GrieskirchenWithdrawn
Wels, Austria
AZORG Campus Aalst-MoorselbaanRecruiting
Aalst, Belgium
CHU St Pierre (St Pierre)Active Not Recruiting
Brussels, Belgium
Cliniques Universitaires St-LucActive Not Recruiting
Brussels, Belgium
AZ OostendeRecruiting
Ostend, Belgium
Instituto Lobus Unimed Volta RedondaRecruiting
Volta Redonda, Rio de Janeiro, Brazil
Hospital Moinhos de VentoRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Newdata Clinical TrialsRecruiting
Aracaju, Sergipe, Brazil
CECIP - Centro de Estudos Clínicos do Interior PaulistaRecruiting
Jaú, São Paulo, Brazil
Hospital Sírio-LibanêsRecruiting
São Paulo, São Paulo, Brazil
Centro Paulista de Investigacao Clinica - CEPICRecruiting
São Paulo, São Paulo, Brazil
Second Multiprofile Hospital For Active Treatment-SofiaWithdrawn
Sofia Town, Sofia, Bulgaria
MC " Sveti Ivan Rilski Chudotvorets- 2010Recruiting
Plovdiv, Bulgaria
"City Clinic UMHAC" EOODRecruiting
Sofia, Bulgaria
Barrie GI AssociatesRecruiting
Barrie, Ontario, Canada
GNRR Digestive Clinics and Research Center Inc.Recruiting
Brampton, Ontario, Canada
London Health Sciences Centre Uni CampusRecruiting
London, Ontario, Canada
TIDHI Innovation Inc.Recruiting
Toronto, Ontario, Canada
CIUSSS-de-l?Est-de-l?Île-de-MontréalRecruiting
Montreal, Quebec, Canada
Centro de Investigación Clínica UC-CICUCRecruiting
Santiago, Chile
Beijing No.6 HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affilliated Hospital of Kunming Medical UniversityRecruiting
Kunming, Yunnan, China
Third Xiangya Hospital Centrel South UniversityRecruiting
Changsha, China
West China Hospital of Sichuan UniversityRecruiting
Chengdu, China
Guangzhou First People's HospitalRecruiting
Guangzhou, China
The second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang UniversityRecruiting
Hangzhou, China
Huizhou Central People's HospitalRecruiting
Huizhou, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
The First Affiliate Hospital of Guangxi Medical UniversityRecruiting
Nanning, China
The First Affiliated Hospital of Ningbo UniversityRecruiting
Ningbo, China
The Affiliated Hospital of Medical College Qingdao UniversityRecruiting
Qingdao, China
Ruijin Hospital Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, China
Shengjing Hospital of China Medical UniversityRecruiting
Shenyang, China
First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
The First Affiliated Hospital of Xiamen UniversityRecruiting
Xiamen, China
Zhongshan Hospital Xiamen UniversityRecruiting
Xiamen, China
Borzan PolyclinicRecruiting
Osijek, Croatia
Clinical Hospital Center Sestre MilosrdniceRecruiting
Zagreb, Croatia
Hepato-Gastroenterologie HK, s.r.o.Recruiting
Hradec Králové, Czechia
Fakultni nemocnice OstravaRecruiting
Ostrava - Poruba, Czechia
ISCARE a.s.Recruiting
Prague, Czechia
Ålborg Universitets HospitalRecruiting
Aalborg, Denmark
CHU Tours - Hôpital TrousseauRecruiting
Chambray-lès-Tours, France
CHU Clermont Ferrand - Hôtel DieuRecruiting
Clermont-Ferrand, France
Hôpital Henri MondorRecruiting
Créteil, France
Polyclinique Grand SudRecruiting
Nîmes, France
Hôpital de Brabois AdultesRecruiting
Vandœuvre-lès-Nancy, France
Universitätsklinikum HeidelbergWithdrawn
Heidelberg, Germany
Medizinisches Zentrum Klinikum LueneburgRecruiting
Lüneburg, Germany
Klinikum Ernst von BergmannWithdrawn
Potsdam, Germany
Észak-Pesti Centrumkórház-HonvédkórházWithdrawn
Budapest, Hungary
Semmelweis EgyetemRecruiting
Budapest, Hungary
Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi KozpontRecruiting
Debrecen, Hungary
Fejer Varmegyei Szent György Egyetemi OktatokorhazRecruiting
Székesfehérvár, Hungary
Vas-Oxy Egeszsegugyi KftRecruiting
Szombathely, Hungary
Surat Institute of Digestive Sciences HospitalsRecruiting
Surat, Gujarat, India
Gujarat Gastro and Vascular HospitalRecruiting
Surat, Gujarat, India
Kingsway HospitalCompleted
Nagpur (urban), Maharashtra, India
MIDAS Multispeciality HospitalRecruiting
Nagpur (urban), Maharashtra, India
Sahyadri Super Speciality HospitalRecruiting
Nashik, Maharashtra, India
SR Kalla Memorial Gastro & General HospitalRecruiting
Jaipur, Rajasthan, India
SMS Superspeciality HospitalRecruiting
Jaipur, Rajasthan, India
AIG HospitalsRecruiting
Gachibowli, Telangana, India
Yashoda HospitalsRecruiting
Secunderabad, Telangana, India
Soroka Medical CenterRecruiting
Beersheba, Israel
The Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via MassarentiRecruiting
Bologna, Emilia-Romagna, Italy
Policlinico Universitario Campus Biomedico Di RomaRecruiting
Rome, Lazio, Italy
Ospedale Isola Tiberina GemelliRecruiting
Rome, Lazio, Italy
Asst Degli Spedali Civili Di BresciaRecruiting
Brescia, Lombardy, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Azienda Ospedaliera San Gerardo di MonzaRecruiting
Monza MI, Lombardy, Italy
Istituto Clinico HumanitasRecruiting
Rozzano (MI), Lombardy, Italy
IRCCS Ospedale Sacro Cuore Don CalabriaRecruiting
Negrar, Veneto, Italy
Boca Clinical Trials Mexico S.C. (Cd. Mexico)Recruiting
Miguel Hidalgo, Mexico CITY (federal District), Mexico
FAICIC S de R.L. de C.VRecruiting
Veracruz, Mexico
ETZ ElisabethActive Not Recruiting
Tilburg, Netherlands
Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.Recruiting
?ód?, Poland
Gastromed Kralisz, Romatowski, Stachurska sp.j.Withdrawn
Bia?ystok, Poland
Medical Center KermedRecruiting
Bydgoszcz, Poland
Szpital Miejski sw. Jana Paw?a II w ElblaguRecruiting
Elblag, Poland
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -WendrowskaWithdrawn
Grudzadz, Poland
Osrodek Badan Klinicznych Bd ResearchRecruiting
I?awa, Poland
MZ Badania Slowik Zymla Sp.j.Recruiting
Knurów, Poland
Centrum Medyczne PromedRecruiting
Krakow, Poland
Medrise sp z o.oRecruiting
Lublin, Poland
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka KomandytowaRecruiting
Poznan, Poland
EMC Instytut Medyczny SARecruiting
Późna, Poland
Gabinety Lekarskie RivermedRecruiting
Późna, Poland
Endoskopia Sp. z o.o.Recruiting
Sopot, Poland
Sonomed Sp. z o.o.Recruiting
Szczecin, Poland
Centrum Zdrowia-MDMRecruiting
Warsaw, Poland
Medon Clinical Research sp. z o.oRecruiting
Warsaw, Poland
Vivamed Spolka Z Ograniczona OdpowiedzialnosciaRecruiting
Warsaw, Poland
PlanetMed sp. z o.o.Recruiting
Wroc?aw, Poland
Centrum Medyczne OporowRecruiting
Wroclaw, Poland
Hospital de BragaRecruiting
Braga, Portugal
Hospital da Luz LisboaRecruiting
Lisbon, Portugal
Centro Hospitalar do Algarve - Hospital de PortimaoRecruiting
Portimão, Portugal
Hospital de Sao JoaoRecruiting
Porto, Portugal
Centro Hospitalar de Entre Douro e Vouga - H. São SebastiãoRecruiting
Santa Maria da Feira, Portugal
Hospital Sao TeotonioRecruiting
Viseu, Portugal
Klinical Investigations Group LLCRecruiting
San Juan, Puerto Rico
General Hospital "Djordje Joanovic"Recruiting
Zrenjanin, Serbia
KM Management spol. s r.o.Withdrawn
Nitra, Slovakia
Accout Center s.r.o.Withdrawn
Šahy, Slovakia
Hospital Universitario Puerta de Hierro MajadahondaActive Not Recruiting
Majadahonda, Madrid, Spain
Hospital Clinico Univ. Lozano BlesaWithdrawn
Zaragoza, Spain
Hospital Universitario Miguel ServetActive Not Recruiting
Zaragoza, Spain
China Medical University HospitalRecruiting
Taichung, Taiwan
Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai UniversityRecruiting
Chiang Mai, Thailand
Burapha University HospitalRecruiting
Chon Buri, Thailand
Sunpasitthiprasong HospitalRecruiting
Ubonratchathani, Thailand
Leicester General HospitalRecruiting
Leicester, United Kingdom
Bronglais General HospitalRecruiting
Llanrhystud, United Kingdom
King College Hospital NHS Foundation TrustRecruiting
London, United Kingdom
Peterborough City HospitalRecruiting
Peterborough, United Kingdom
Stepping Hill HospitalRecruiting
Stockport, United Kingdom
New Cross HospitalRecruiting
Wolverhampton, United Kingdom
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 · TrialPath