A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease
NCT ID: NCT06819891
Last Updated: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
425 participants
INTERVENTIONAL
2025-05-12
2029-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Placebo
Participants will receive placebo IV followed by afimkibart SC injection.
Placebo
Placebo matching IV afimkibart.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Afimkibart
Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.
Placebo
Placebo matching IV afimkibart.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
16 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun City Clinical Research
Glendale, Arizona, United States
Om Research LLC
Lancaster, California, United States
Amicis Research Center
Santa Clarita, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
J&A Clinical Research
Doral, Florida, United States
Homestead Associates in Research, Inc.
Miami, Florida, United States
Allied Biomedical Research Institute, Inc
Miami, Florida, United States
Rejuvaline Medical Research
Miami, Florida, United States
Miami Beach Clinical Research Center
Miami Beach, Florida, United States
Eminat Research Group
Miramar, Florida, United States
Digestive and Liver Center of Florida
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Santos Research Center, CORP
Tampa, Florida, United States
Robley Rex VA Medical Center
Louisville, Kentucky, United States
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States
Gastrointestinal Associates Research
Flowood, Mississippi, United States
Ellipsis Research Group
Brooklyn, New York, United States
Intercity Gastroenterology
Fresh Meadows, New York, United States
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
Clinical Inquest Center
Beavercreek, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
GI Alliance
Garland, Texas, United States
Integrity Advanced Therapeutics PLLC
Houston, Texas, United States
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas, United States
University of Texas Health Center at Tyler
Tyler, Texas, United States
University Physicians and Surgeons Inc, dba Marshall Health
Huntington, West Virginia, United States
CICE 9 de Julio
San Miguel de Tucumán, , 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
CHU St Pierre (St Pierre)
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , 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 de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
MC " Sveti Ivan Rilski Chudotvorets- 2010
Plovdiv, , Bulgaria
Barrie GI Associates
Barrie, Ontario, Canada
London Health Sciences Centre Uni Campus
London, Ontario, Canada
Toronto Immune and Digestive Health Institute
North YORK, Ontario, Canada
Centro de Investigación Clínica UC-CICUC
Santiago, , Chile
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The First Affilliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Jinhua municipal central hospital
Jinhua, Zhejiang, China
Beijing Union Hospital
Beijing, , China
Sichuan Provincial People's Hospital
Chengdu, , China
Guangzhou First People's Hospital
Guangzhou, , China
Zhujiang Hospital, Southern Medical University
Guangzhou, , China
Hainan General Hospital
Haikou, , China
Huizhou First Hospital
Huizhou, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Hebei Medical University - The Second Hospital
Shijiazhuang, , China
The Second Affiliated Hospital of Soochow University
Suzhou, , China
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
Hospital Universitario San Ignacio
Bogotá, , Colombia
Clínica de la Mujer
Bogotá, , Colombia
Oncomedica S.A.
Montería, , Colombia
Borzan Polyclinic
Osijek, , Croatia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Institutu Klinicke a Experimentaini Mediciny (IKEM);Klinika hepatogastroenterologie
Prague, , Czechia
ISCARE a.s.
Prague, , Czechia
Krajska zdravotni, a.s. ? Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni
Ústí nad Labem, , Czechia
CHU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont-Ferrand, , France
Hôpital Henri Mondor
Créteil, , France
CH Dptal Les Oudairies
La Roche-sur-Yon, , France
CHRU de Lille - Hopital Claude Huriez
Lille, , France
Hopital Dupuytren
Limoges, , France
Hopital Saint-Eloi
Montpellier, , France
Institut des MICI, Clinique Ambroise Paré
Neuilly-sur-Seine, , France
Hôpital Saint-Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Észak-Pesti Centrumkórház-Honvédkórház
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Vas-Oxy Egeszsegugyi Kft
Szombathely, , Hungary
AIG Hospitals
Gachibowli, Telangana, India
Yashoda Hospitals
Secunderabad, Telangana, India
Shaare Zedek Medical Center
Jerusalem, , Israel
Ospedale Madonna delle Grazie
Matera, Basilicate, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, Emilia-Romagna, Italy
Policlinico Universitario Campus Biomedico Di Roma
Rome, Lazio, Italy
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
I.R.C.C.S Policlinico San Donato
San Donato Milanese (MI), Lombardy, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Veneto, Italy
Gastromed Kralisz, Romatowski, Stachurska sp.j.
Bia?ystok, , Poland
Medical Center Kermed
Bydgoszcz, , 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
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
Hospital de Braga
Braga, , Portugal
Hospital de Santa Maria
Lisbon, , 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
Fundacion Hospital de Alcorcon
Alcorcón, Madrid, Spain
Hospital Clinico Univ. Lozano Blesa
Zaragoza, , Spain
Fairfield General Hospital
Bury, , United Kingdom
Bronglais General Hospital
Llanrhystud, , United Kingdom
Royal London Hospital
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: GA45332 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. and Canada)
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-513054-30-00
Identifier Type: CTIS
Identifier Source: secondary_id
GA45332
Identifier Type: -
Identifier Source: org_study_id