What this study is
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).
What's being tested
- Afimkibart
Intervention · DRUG
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
- Placebo
Intervention · DRUG
Placebo matching IV afimkibart.
Study details
- 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
- Sponsor
- Hoffmann-La Roche
- Conditions
- Moderately to Severely Active Crohns Disease
- Enrolling
- 425 people
- Starts
- 2025-05-12
- Est. completion
- 2033-04-30
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 16 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Confirmed diagnosis of CD
- Moderately to severely active CD
- Bodyweight >= 40 kilogram (kg)
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced CD therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
You can't join if
- Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis
- Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)
- Diagnosis of short gut or short bowel syndrome
- Presence of an ileostomy, colostomy or ileoanal pouch
- Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon
- Presence of abdominal or perianal abscess
- Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with >3 openings
- 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, high-grade colonic dysplasia and participants with low-grade dysplasia are eligible if lesions have been completely removed
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (208)
198 openDigestive Health Specialists of the Southeast
Dothan, Alabama, United States
RecruitingSun City Clinical Research
Glendale, Arizona, United States
RecruitingOm Research LLC
Lancaster, California, United States
RecruitingHoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
Newport Beach, California, United States
RecruitingStanford Medicine Outpatient Center
Redwood City, California, United States
RecruitingClinical Applications Laboratories, Inc.
San Diego, California, United States
RecruitingAmicis Research Center
Santa Clarita, California, United States
RecruitingPeak Gastroenterology Associates
Colorado Springs, Colorado, United States
RecruitingJ&A Clinical Research
Doral, Florida, United States
RecruitingAuzmer Research
Lakeland, Florida, United States
RecruitingGalenus Group Inc
Lehigh Acres, Florida, United States
RecruitingHomestead Associates in Research, Inc.
Miami, Florida, United States
RecruitingAllied Biomedical Research Institute, Inc
Miami, Florida, United States
RecruitingRejuvaline Medical Research
Miami, Florida, United States
RecruitingMiami Beach Clinical Research Center
Miami Beach, Florida, United States
RecruitingEminat Research Group
Miramar, Florida, United States
RecruitingDigestive and Liver Center of Florida
Orlando, Florida, United States
RecruitingAdvanced Medical Research Center
Port Orange, Florida, United States
RecruitingSantos Research Center, CORP
Tampa, Florida, United States
RecruitingCleveland Clinic Florida
Weston, Florida, United States
RecruitingMorehouse School Of Medicine
Atlanta, Georgia, United States
RecruitingThe University of Chicago
Chicago, Illinois, United States
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RecruitingRobley Rex VA Medical Center
Louisville, Kentucky, United States
RecruitingOne GI: GHP - Gastroenterology Health Partners Louisville
Louisville, Kentucky, United States
RecruitingBaton Rouge General Medical Center
Baton Rouge, Louisiana, United States
RecruitingLouisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States
RecruitingMercy Medical Center
Baltimore, Maryland, United States
RecruitingFOMAT Medical Research - Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
RecruitingUniversity of Massachusetts Memorial Medical Center
North Worcester, Massachusetts, United States
RecruitingGastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States
RecruitingGastrointestinal Associates Research
Flowood, Mississippi, United States
RecruitingVa Heartland Network - Harry S. Truman Memorial Veterans' Hospital
Columbia, Missouri, United States
RecruitingSpecialists in Gastroenterology
St Louis, Missouri, United States
RecruitingDartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
RecruitingVirtua Crohns and Colitis Center
Moorestown, New Jersey, United States
RecruitingRobert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
RecruitingEllipsis Research Group
Brooklyn, New York, United States
RecruitingIntercity Gastroenterology
Fresh Meadows, New York, United States
RecruitingNYU Langone Long Island Clinical Research Associates
Lake Success, New York, United States
RecruitingJames J Peters Veterans Affairs Medical Center
The Bronx, New York, United States
RecruitingDigestive Disease Medicine of Central New York
Utica, New York, United States
RecruitingCharlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
RecruitingPeters Medical Research (PMR), LLC
High Point, North Carolina, United States
RecruitingClinical Inquest Center
Beavercreek, Ohio, United States
RecruitingCleveland Clinic Foundation
Cleveland, Ohio, United States
RecruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RecruitingUniversity Gastroenterology
Providence, Rhode Island, United States
RecruitingGastro One
Cordova, Tennessee, United States
RecruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
RecruitingUniversity of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
Dallas, Texas, United States
RecruitingGI Alliance - Fort Worth
Fort Worth, Texas, United States
RecruitingGI Alliance
Garland, Texas, United States
RecruitingIntegrity Advanced Therapeutics PLLC
Houston, Texas, United States
RecruitingTexas Digestive Disease Consultants-Lubbock powered by GI Alliance
Lubbock, Texas, United States
RecruitingCarta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, United States
RecruitingTyler Research Institute, LLC
Tyler, Texas, United States
RecruitingUniversity of Texas Health Center at Tyler
Tyler, Texas, United States
RecruitingTDDC GI Alliance research Webster
Webster, Texas, United States
RecruitingGI Alliance-Richmond
Richmond, Virginia, United States
RecruitingVirginia Mason Medical Center
Seattle, Washington, United States
RecruitingWashington Gastroenterology
Tacoma, Washington, United States
RecruitingEmpire Clinical Research
Pomona, California, United States
WithdrawnUniversity Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia, United States
Withdrawn
144 sites outside the US
Instituto Medico CER
Quilmes, Argentina
RecruitingCICE 9 de Julio
San Miguel de Tucumán, Argentina
RecruitingMacquarie University Hospital
Macquarie Park, New South Wales, Australia
RecruitingSydney Adventist Hospital
Wahroonga, New South Wales, Australia
RecruitingLyell McEwin Hospital
Adelaide, South Australia, Australia
RecruitingFootscray Hospital
Footscray, Victoria, Australia
RecruitingRoyal Melbourne Hospital
Parkville, Victoria, Australia
RecruitingOrdensklinikum Linz Barmherzige Schwestern
Linz, Austria
RecruitingKlinikum Wels-Grieskirchen
Wels, Austria
RecruitingCHU St Pierre (St Pierre)
Brussels, Belgium
RecruitingUZ Brussel
Brussels, Belgium
RecruitingCliniques Universitaires St-Luc
Brussels, Belgium
RecruitingInstituto Lobus Unimed Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil
RecruitingHospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
RecruitingNewdata Clinical Trials
Aracaju, Sergipe, Brazil
RecruitingCECIP - Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
RecruitingHospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
RecruitingMultiprofile Hospital for Active Treatment Uni Hospital;Department of Gastroenterology.
Panagyurishte, Bulgaria
RecruitingMC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, Bulgaria
RecruitingBarrie GI Associates
Barrie, Ontario, Canada
RecruitingGNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada
RecruitingLDDI Clinical Trials Inc.
London, Ontario, Canada
RecruitingToronto Immune and Digestive Health Institute
North YORK, Ontario, Canada
RecruitingCIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
RecruitingMedicina de Precisión - Celerity
Las Condes, Chile
RecruitingMedwal
Santiago, Chile
RecruitingCentro de Investigación Clínica UC-CICUC
Santiago, Chile
RecruitingFirst Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
RecruitingJinhua municipal central hospital
Jinhua, Zhejiang, China
RecruitingBeijing Union Hospital
Beijing, China
RecruitingSichuan Provincial People's Hospital
Chengdu, China
RecruitingGuangzhou First People's Hospital
Guangzhou, China
RecruitingZhujiang Hospital, Southern Medical University
Guangzhou, China
RecruitingHainan General Hospital
Haikou, China
RecruitingHuai'an First People's Hospital
Huai'an, China
RecruitingHuizhou First Hospital
Huizhou, China
RecruitingThe First Affilliated Hospital of Kunming Medical University
Kunming, China
RecruitingThe Second Affiliated Hospital of Nanchang University
Nanchang, China
RecruitingXinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RecruitingRenji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
RecruitingShengjing Hospital of China Medical University
Shenyang, China
RecruitingHebei Medical University - The Second Hospital
Shijiazhuang, China
RecruitingThe Second Affiliated Hospital of Soochow University
Suzhou, China
RecruitingThe Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China
RecruitingThe First Affiliated Hospital of Xiamen University
Xiamen, China
RecruitingAffiliated Hospital of Jiangsu University
Zhenjiang, China
RecruitingFundacion Cardiovascular de Colombia - KM 7 Autopista
Piedecuesta, Santander Department, Colombia
RecruitingHospital Universitario San Ignacio
Bogotá, Colombia
RecruitingClinica Colsanitas S.A. - Sede Clinica Reina Sofia
Bogotá, Colombia
RecruitingOncomedica S.A.
Montería, Colombia
RecruitingBorzan Polyclinic
Osijek, Croatia
RecruitingClinical Hospital Centre Zagreb
Zagreb, Croatia
RecruitingHepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
RecruitingFakultni nemocnice Ostrava
Ostrava - Poruba, Czechia
RecruitingInstitutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
Prague, Czechia
RecruitingISCARE a.s.
Prague, Czechia
RecruitingKrajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, Czechia
RecruitingCHU Tours - Hôpital Trousseau
Chambray-lès-Tours, France
RecruitingCHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, France
RecruitingHôpital Henri Mondor
Créteil, France
RecruitingCH Dptal Les Oudairies
La Roche-sur-Yon, France
RecruitingCHRU de Lille - Hopital Claude Huriez
Lille, France
RecruitingHopital Dupuytren
Limoges, France
RecruitingHopital Saint-Eloi
Montpellier, France
RecruitingHôpital Saint-Louis
Paris, France
RecruitingHôpital de Brabois Adultes
Vandœuvre-lès-Nancy, France
RecruitingUniversitätsklinikum Heidelberg
Heidelberg, Germany
RecruitingKlinikum Ernst von Bergmann
Potsdam, Germany
RecruitingÉszak-Pesti Centrumkórház-Honvédkórház
Budapest, Hungary
RecruitingGeomedical Orvosi Kft
Budapest, Hungary
RecruitingSemmelweis Egyetem
Budapest, Hungary
RecruitingEndomedix Kft.
Budapest, Hungary
RecruitingVas-Oxy Egeszsegugyi Kft
Szombathely, Hungary
RecruitingKurnool Medical College
Kurnool, Andhra Pradesh, India
RecruitingSurat Institute of Digestive Sciences Hospitals
Surat, Gujarat, India
RecruitingGujarat Gastro and Vascular Hospital
Surat, Gujarat, India
RecruitingAmrita Institute of Medical Sciences
Kochi, Kerala, India
RecruitingMIDAS Multispeciality Hospital
Nagpur (urban), Maharashtra, India
RecruitingAll India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
RecruitingSR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
RecruitingSMS Superspeciality Hospital
Jaipur, Rajasthan, India
RecruitingAIG Hospitals
Gachibowli, Telangana, India
RecruitingGandhi Hospital
Secunderabad, Telangana, India
RecruitingYashoda Hospitals
Secunderabad, Telangana, India
RecruitingInstitute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital
Kolkata, West Bengal, India
RecruitingShaare Zedek Medical Center
Jerusalem, Israel
RecruitingHadassah Medical Center
Jerusalem, Israel
RecruitingOspedale Madonna delle Grazie
Matera, Basilicate, Italy
RecruitingAzienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy
RecruitingPoliclinico Universitario Campus Biomedico Di Roma
Rome, Lazio, Italy
RecruitingPoliclinico Universitario Agostino Gemelli
Rome, Lazio, Italy
RecruitingAsst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
RecruitingIRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
RecruitingI.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
RecruitingIRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, Italy
RecruitingGastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, Poland
RecruitingMedical Center Kermed
Bydgoszcz, Poland
RecruitingSzpital Miejski sw. Jana Paw?a II w Elblagu
Elblag, Poland
RecruitingOsrodek Badan Klinicznych Bd Research
I?awa, Poland
RecruitingMZ Badania Slowik Zymla Sp.j.
Knurów, Poland
RecruitingCentrum Medyczne Promed
Krakow, Poland
RecruitingAmicare Sp. z o.o. S.K.
Lodz, Poland
RecruitingMedrise sp z o.o
Lublin, Poland
RecruitingClinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Poznan, Poland
RecruitingEMC Instytut Medyczny SA
Późna, Poland
RecruitingGabinety Lekarskie Rivermed
Późna, Poland
RecruitingEndoskopia Sp. z o.o.
Sopot, Poland
RecruitingNowe Zdrowie-CK Kieltucki I Wspolnicy Sp. j.
Staszów, Poland
RecruitingSonomed Sp. z o.o.
Szczecin, Poland
RecruitingCentrum Zdrowia-MDM
Warsaw, Poland
RecruitingMedon Clinical Research sp. z o.o
Warsaw, Poland
RecruitingVivamed Spolka Z Ograniczona Odpowiedzialnoscia
Warsaw, Poland
RecruitingPlanetMed sp. z o.o.
Wroc?aw, Poland
RecruitingHospital de Braga
Braga, Portugal
RecruitingHospital de Santa Maria
Lisbon, Portugal
RecruitingHospital de Sao Joao
Porto, Portugal
RecruitingCentro Hospitalar de Entre Douro e Vouga - H. São Sebastião
Santa Maria da Feira, Portugal
RecruitingHospital Sao Teotonio
Viseu, Portugal
RecruitingGalenus Group Of Puerto Rica Inc
Manati, Puerto Rico
RecruitingSpital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
Cluj-Napoca, Romania
RecruitingABAWI spol. s r.o.
Bratislava, Slovakia
RecruitingKM Management spol. s r.o.
Nitra, Slovakia
RecruitingKorea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
RecruitingYeungnam University Medical Center
Daegu, South Korea
RecruitingChosun University Hospital
Gwangju, South Korea
RecruitingThe Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea
RecruitingHanyang University Seoul Hospital
Seoul, South Korea
RecruitingFundacion Hospital de Alcorcon
Alcorcón, Madrid, Spain
RecruitingHospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
RecruitingHospital General Universitario Gregorio Maranon
Madrid, Spain
RecruitingHospital Clinico Univ. Lozano Blesa
Zaragoza, Spain
RecruitingSouthmead Hospital
Bristol, United Kingdom
RecruitingFairfield General Hospital
Bury, United Kingdom
RecruitingBronglais General Hospital
Llanrhystud, United Kingdom
RecruitingRoyal London Hospital
London, United Kingdom
RecruitingRoyal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
RecruitingCoral Sea Clinical Research Institute
Mackay, Queensland, Australia
WithdrawnHospital Sírio-Libanês
São Paulo, São Paulo, Brazil
WithdrawnLondon Health Sciences Centre Uni Campus
London, Ontario, Canada
WithdrawnClínica de la Mujer
Bogotá, Colombia
WithdrawnCentre hospitalier Lyon Sud
Pierre-Bénite, Rhône, France
Active, not recruitingInstitut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, France
Active, not recruitingShree Giriraj Multispeciality Hospital
Rajkot, Gujarat, India
WithdrawnStepping Hill Hospital
Stockport, United Kingdom
Active, not recruiting
Study team
Sponsor
Hoffmann-La Roche
Study ID GA45332
Study director
Clinical Trials
Hoffmann-La Roche
CONTACT
Reference Study ID Number: GA45332 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
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.