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A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
NCT06819891 · 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 Crohn's Disease
About this study
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Eligibility criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
* 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
Study design
Enrollment target: 425 participants
Allocation: randomized
Masking: double
Age groups: child, adult, older_adult
Timeline
Starts: 2025-05-12
Estimated completion: 2033-04-30
Last updated: 2026-04-13
Interventions
Drug: AfimkibartDrug: Placebo
Primary outcomes
- • Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score (At Week 12)
- • Percentage of Participants with Endoscopic Response (At Week 12)
Sponsor
Hoffmann-La Roche · industry
With: Chugai Pharmaceutical
Contacts & investigators
ContactReference Study ID Number: GA45332 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 (167)
Sun City Clinical ResearchRecruiting
Glendale, Arizona, United States
Om Research LLCRecruiting
Lancaster, California, United States
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and EducationRecruiting
Newport Beach, California, United States
Empire Clinical ResearchWithdrawn
Pomona, California, United States
Stanford Medicine Outpatient CenterRecruiting
Redwood City, California, United States
Clinical Applications Laboratories, Inc.Recruiting
San Diego, California, United States
Amicis Research CenterRecruiting
Santa Clarita, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
J&A Clinical ResearchRecruiting
Doral, Florida, United States
Homestead Associates in Research, Inc.Recruiting
Miami, Florida, United States
Allied Biomedical Research Institute, IncRecruiting
Miami, Florida, United States
Rejuvaline Medical ResearchRecruiting
Miami, Florida, United States
Miami Beach Clinical Research CenterRecruiting
Miami Beach, Florida, United States
Eminat Research GroupRecruiting
Miramar, Florida, United States
Digestive and Liver Center of FloridaRecruiting
Orlando, Florida, United States
Advanced Medical Research CenterRecruiting
Port Orange, Florida, United States
Santos Research Center, CORPRecruiting
Tampa, Florida, United States
Cleveland Clinic FloridaRecruiting
Weston, Florida, United States
The University of ChicagoRecruiting
Chicago, Illinois, United States
Robley Rex VA Medical CenterRecruiting
Louisville, Kentucky, United States
Baton Rouge General Medical CenterRecruiting
Baton Rouge, Louisiana, United States
Louisiana Research Center - GastroIntestinal AssociatesRecruiting
Shreveport, Louisiana, United States
Mercy Medical CenterRecruiting
Baltimore, Maryland, United States
Chevy Chase Clinical ResearchRecruiting
Chevy Chase, Maryland, United States
University of Massachusetts Memorial Medical CenterRecruiting
North Worcester, Massachusetts, United States
Gastroenterology Associates of Western Michigan, P.L.C.Recruiting
Wyoming, Michigan, United States
Gastrointestinal Associates ResearchRecruiting
Flowood, Mississippi, United States
Virtua Crohns and Colitis CenterRecruiting
Moorestown, New Jersey, United States
Robert Wood Johnson University HospitalRecruiting
New Brunswick, New Jersey, United States
Ellipsis Research GroupRecruiting
Brooklyn, New York, United States
Intercity GastroenterologyRecruiting
Fresh Meadows, New York, United States
James J Peters Veterans Affairs Medical CenterRecruiting
The Bronx, New York, United States
Digestive Disease Medicine of Central New YorkRecruiting
Utica, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.CRecruiting
Charlotte, North Carolina, United States
Clinical Inquest CenterRecruiting
Beavercreek, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care CenterRecruiting
Dallas, Texas, United States
GI Alliance - Fort WorthRecruiting
Fort Worth, Texas, United States
GI AllianceRecruiting
Garland, Texas, United States
Integrity Advanced Therapeutics PLLCRecruiting
Houston, Texas, United States
Texas Digestive Disease Consultants-Lubbock powered by GI AllianceRecruiting
Lubbock, Texas, United States
Carta - Clinical Associates In Research Therapeutics Of America;LLCRecruiting
San Antonio, Texas, United States
University of Texas Health Center at TylerRecruiting
Tyler, Texas, United States
TDDC GI Alliance research WebsterRecruiting
Webster, Texas, United States
University Physicians and Surgeons Inc, dba Marshall HealthRecruiting
Huntington, West Virginia, United States
Instituto Medico CERRecruiting
Quilmes, Argentina
CICE 9 de JulioRecruiting
San Miguel de Tucumán, Argentina
Macquarie University HospitalRecruiting
Macquarie Park, New South Wales, Australia
Coral Sea Clinical Research InstituteWithdrawn
Mackay, Queensland, Australia
Footscray HospitalRecruiting
Footscray, Victoria, Australia
Royal Melbourne HospitalRecruiting
Parkville, Victoria, Australia
Ordensklinikum Linz Barmherzige SchwesternRecruiting
Linz, Austria
Klinikum Wels-GrieskirchenRecruiting
Wels, Austria
CHU St Pierre (St Pierre)Recruiting
Brussels, Belgium
UZ BrusselRecruiting
Brussels, Belgium
Cliniques Universitaires St-LucRecruiting
Brussels, 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 de Base de Sao Jose do Rio PretoRecruiting
São José do Rio Preto, São Paulo, Brazil
Hospital Sírio-LibanêsRecruiting
São Paulo, São Paulo, Brazil
MC " Sveti Ivan Rilski Chudotvorets- 2010Recruiting
Plovdiv, 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
LDDI Clinical Trials Inc.Recruiting
London, Ontario, Canada
Toronto Immune and Digestive Health InstituteRecruiting
North YORK, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve RosemontRecruiting
Montreal, Quebec, Canada
Medicina de Precisión - CelerityRecruiting
Las Condes, Chile
Centro de Investigación Clínica UC-CICUCRecruiting
Santiago, Chile
First Affiliated Hospital of Gannan Medical UniversityRecruiting
Ganzhou, Jiangxi, China
The First Affilliated Hospital of Kunming Medical UniversityRecruiting
Kunming, Yunnan, China
Jinhua municipal central hospitalRecruiting
Jinhua, Zhejiang, China
Beijing Union HospitalRecruiting
Beijing, China
Sichuan Provincial People's HospitalRecruiting
Chengdu, China
Guangzhou First People's HospitalRecruiting
Guangzhou, China
Zhujiang Hospital, Southern Medical UniversityRecruiting
Guangzhou, China
Hainan General HospitalRecruiting
Haikou, China
Huizhou First HospitalRecruiting
Huizhou, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, China
Shengjing Hospital of China Medical UniversityRecruiting
Shenyang, China
Hebei Medical University - The Second HospitalRecruiting
Shijiazhuang, China
The Second Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
The Second Affiliated Hospital of Xi'an Jiao Tong UniversityRecruiting
Xi'an, China
The First Affiliated Hospital of Xiamen UniversityRecruiting
Xiamen, China
Affiliated Hospital of Jiangsu UniversityRecruiting
Zhenjiang, China
Hospital Universitario San IgnacioRecruiting
Bogotá, Colombia
Clínica de la MujerRecruiting
Bogotá, Colombia
Clinica Colsanitas S.A. - Sede Clinica Reina SofiaRecruiting
Bogotá, Colombia
Oncomedica S.A.Recruiting
Montería, Colombia
Borzan PolyclinicRecruiting
Osijek, Croatia
Hepato-Gastroenterologie HK, s.r.o.Recruiting
Hradec Králové, Czechia
Fakultni nemocnice OstravaRecruiting
Ostrava - Poruba, Czechia
Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologieRecruiting
Prague, Czechia
ISCARE a.s.Recruiting
Prague, Czechia
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleniRecruiting
Ústí nad Labem, Czechia
CHU Tours - Hôpital TrousseauRecruiting
Chambray-lès-Tours, France
CHU Clermont Ferrand - Hôpital d'EstaingRecruiting
Clermont-Ferrand, France
Hôpital Henri MondorRecruiting
Créteil, France
CH Dptal Les OudairiesRecruiting
La Roche-sur-Yon, France
CHRU de Lille - Hopital Claude HuriezRecruiting
Lille, France
Hopital DupuytrenRecruiting
Limoges, France
Hopital Saint-EloiRecruiting
Montpellier, France
Institut des MICI, Clinique Ambroise ParéRecruiting
Neuilly-sur-Seine, France
Hôpital Saint-LouisRecruiting
Paris, France
Centre Hospitalier Lyon SudRecruiting
Pierre-Bénite, France
Hôpital de Brabois AdultesRecruiting
Vandœuvre-lès-Nancy, France
Universitätsklinikum HeidelbergRecruiting
Heidelberg, Germany
Klinikum Ernst von BergmannRecruiting
Potsdam, Germany
Észak-Pesti Centrumkórház-HonvédkórházRecruiting
Budapest, Hungary
Geomedical Orvosi KftRecruiting
Budapest, Hungary
Semmelweis EgyetemRecruiting
Budapest, Hungary
Endomedix Kft.Recruiting
Budapest, Hungary
Vas-Oxy Egeszsegugyi KftRecruiting
Szombathely, Hungary
Shree Giriraj Multispeciality HospitalRecruiting
Rajkot, Gujarat, India
Surat Institute of Digestive Sciences HospitalsRecruiting
Surat, Gujarat, India
Gujarat Gastro and Vascular HospitalRecruiting
Surat, Gujarat, India
Amrita Institute of Medical SciencesRecruiting
Kochi, Kerala, India
MIDAS Multispeciality HospitalRecruiting
Nagpur (urban), Maharashtra, India
All India Institute Of Medical Sciences (AIIMS)Recruiting
New Delhi, National Capital Territory of Delhi, India
SR Kalla Memorial Gastro & General HospitalRecruiting
Jaipur, Rajasthan, India
AIG HospitalsRecruiting
Gachibowli, Telangana, India
Yashoda HospitalsRecruiting
Secunderabad, Telangana, India
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Ospedale Madonna delle GrazieRecruiting
Matera, Basilicate, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via MassarentiRecruiting
Bologna, Emilia-Romagna, Italy
Policlinico Universitario Campus Biomedico Di RomaRecruiting
Rome, Lazio, Italy
Policlinico Universitario Agostino GemelliRecruiting
Rome, Lazio, Italy
Asst Degli Spedali Civili Di BresciaRecruiting
Brescia, Lombardy, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
I.R.C.C.S Policlinico San DonatoRecruiting
San Donato Milanese (MI), Lombardy, Italy
IRCCS Ospedale Sacro Cuore Don CalabriaRecruiting
Negrar, Veneto, Italy
Gastromed Kralisz, Romatowski, Stachurska sp.j.Recruiting
Bia?ystok, Poland
Medical Center KermedRecruiting
Bydgoszcz, Poland
Szpital Miejski sw. Jana Paw?a II w ElblaguRecruiting
Elblag, Poland
Osrodek Badan Klinicznych Bd ResearchRecruiting
I?awa, Poland
MZ Badania Slowik Zymla Sp.j.Recruiting
Knurów, Poland
Centrum Medyczne PromedRecruiting
Krakow, Poland
Amicare Sp. z o.o. S.K.Recruiting
Lodz, 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
Hospital de BragaRecruiting
Braga, Portugal
Hospital de Santa MariaRecruiting
Lisbon, 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
Spital Digenio - Centrul de Excelen?? în Afec?iuni DigestiveRecruiting
Cluj-Napoca, Romania
ABAWI spol. s r.o.Recruiting
Bratislava, Slovakia
KM Management spol. s r.o.Recruiting
Nitra, Slovakia
Fundacion Hospital de AlcorconRecruiting
Alcorcón, Madrid, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Hospital Clinico Univ. Lozano BlesaRecruiting
Zaragoza, Spain
Fairfield General HospitalRecruiting
Bury, United Kingdom
Bronglais General HospitalRecruiting
Llanrhystud, United Kingdom
Royal London HospitalRecruiting
London, United Kingdom