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
Status: Recruiting
Location: See all (162) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 80
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Sun City Clinical Research
RECRUITING
Glendale
California
Om Research LLC
RECRUITING
Lancaster
Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education
RECRUITING
Newport Beach
Empire Clinical Research
WITHDRAWN
Pomona
Stanford Medicine Outpatient Center
RECRUITING
Redwood City
Clinical Applications Laboratories, Inc.
RECRUITING
San Diego
Amicis Research Center
RECRUITING
Santa Clarita
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
J&A Clinical Research
RECRUITING
Doral
Allied Biomedical Research Institute, Inc
RECRUITING
Miami
Homestead Associates in Research, Inc.
RECRUITING
Miami
Rejuvaline Medical Research
RECRUITING
Miami
Miami Beach Clinical Research Center
RECRUITING
Miami Beach
Eminat Research Group
RECRUITING
Miramar
Digestive and Liver Center of Florida
RECRUITING
Orlando
Advanced Medical Research Center
RECRUITING
Port Orange
Santos Research Center, CORP
RECRUITING
Tampa
Cleveland Clinic Florida
RECRUITING
Weston
Illinois
The University of Chicago
RECRUITING
Chicago
Kentucky
Robley Rex VA Medical Center
RECRUITING
Louisville
Louisiana
Baton Rouge General Medical Center
RECRUITING
Baton Rouge
Louisiana Research Center - GastroIntestinal Associates
RECRUITING
Shreveport
Massachusetts
University of Massachusetts Memorial Medical Center
RECRUITING
North Worcester
Maryland
Mercy Medical Center
RECRUITING
Baltimore
Chevy Chase Clinical Research
RECRUITING
Chevy Chase
Michigan
Gastroenterology Associates of Western Michigan, P.L.C.
RECRUITING
Wyoming
Mississippi
Gastrointestinal Associates Research
RECRUITING
Flowood
North Carolina
Charlotte Gastroenterology and Hepatology, P.L.L.C
RECRUITING
Charlotte
New Jersey
Virtua Crohns and Colitis Center
RECRUITING
Moorestown
Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
New York
Ellipsis Research Group
RECRUITING
Brooklyn
Intercity Gastroenterology
RECRUITING
Fresh Meadows
James J Peters Veterans Affairs Medical Center
RECRUITING
The Bronx
Digestive Disease Medicine of Central New York
RECRUITING
Utica
Ohio
Clinical Inquest Center
RECRUITING
Beavercreek
Cleveland Clinic Foundation
RECRUITING
Cleveland
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center - Multidisciplinary Spine Clinic - James W. Aston Ambulatory Care Center
RECRUITING
Dallas
GI Alliance - Fort Worth
RECRUITING
Fort Worth
GI Alliance
RECRUITING
Garland
Integrity Advanced Therapeutics PLLC
RECRUITING
Houston
Texas Digestive Disease Consultants-Lubbock powered by GI Alliance
RECRUITING
Lubbock
Carta - Clinical Associates In Research Therapeutics Of America;LLC
RECRUITING
San Antonio
University of Texas Health Center at Tyler
RECRUITING
Tyler
TDDC GI Alliance research Webster
RECRUITING
Webster
West Virginia
University Physicians and Surgeons Inc, dba Marshall Health
RECRUITING
Huntington
Other Locations
Argentina
Instituto Medico CER
RECRUITING
Quilmes
CICE 9 de Julio
RECRUITING
San Miguel De Tucumán
Australia
Footscray Hospital
RECRUITING
Footscray
Coral Sea Clinical Research Institute
WITHDRAWN
Mackay
Macquarie University Hospital
RECRUITING
Macquarie Park
Royal Melbourne Hospital
RECRUITING
Parkville
Austria
Ordensklinikum Linz Barmherzige Schwestern
RECRUITING
Linz
Klinikum Wels-Grieskirchen
RECRUITING
Wels
Belgium
CHU St Pierre (St Pierre)
RECRUITING
Brussels
Cliniques Universitaires St-Luc
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
Brazil
Newdata Clinical Trials
RECRUITING
Aracaju
CECIP - Centro de Estudos Clínicos do Interior Paulista
RECRUITING
Jaú
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Hospital de Base de Sao Jose do Rio Preto
RECRUITING
São José Do Rio Preto
Hospital Sírio-Libanês
RECRUITING
São Paulo
Instituto Lobus Unimed Volta Redonda
RECRUITING
Volta Redonda
Bulgaria
MC Sveti Ivan Rilski Chudotvorets- 2010
RECRUITING
Plovdiv
Canada
Barrie GI Associates
RECRUITING
Barrie
GNRR Digestive Clinics and Research Center Inc.
RECRUITING
Brampton
LDDI Clinical Trials Inc.
RECRUITING
London
London Health Sciences Centre Uni Campus
RECRUITING
London
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont
RECRUITING
Montreal
Toronto Immune and Digestive Health Institute
RECRUITING
North York
Chile
Medicina de Precisión - Celerity
RECRUITING
Las Condes
Centro de Investigación Clínica UC-CICUC
RECRUITING
Santiago
China
Beijing Union Hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
First Affiliated Hospital of Gannan Medical University
RECRUITING
Ganzhou
Guangzhou First People's Hospital
RECRUITING
Guangzhou
Zhujiang Hospital, Southern Medical University
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
Huizhou First Hospital
RECRUITING
Huizhou
Jinhua municipal central hospital
RECRUITING
Jinhua
The First Affilliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Hebei Medical University - The Second Hospital
RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Second Affiliated Hospital of Xi'an Jiao Tong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Colombia
Clinica Colsanitas S.A. - Sede Clinica Reina Sofia
RECRUITING
Bogotá
Clínica de la Mujer
RECRUITING
Bogotá
Hospital Universitario San Ignacio
RECRUITING
Bogotá
Oncomedica S.A.
RECRUITING
Montería
Croatia
Borzan Polyclinic
RECRUITING
Osijek
France
CHU Tours - Hôpital Trousseau
RECRUITING
Chambray-lès-tours
CHU Clermont Ferrand - Hôpital d'Estaing
RECRUITING
Clermont-ferrand
Hôpital Henri Mondor
RECRUITING
Créteil
CH Dptal Les Oudairies
RECRUITING
La Roche-sur-yon
CHRU de Lille - Hopital Claude Huriez
RECRUITING
Lille
Hopital Dupuytren
RECRUITING
Limoges
Hopital Saint-Eloi
RECRUITING
Montpellier
Institut des MICI, Clinique Ambroise Paré
RECRUITING
Neuilly-sur-seine
Hôpital Saint-Louis
RECRUITING
Paris
Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Hôpital de Brabois Adultes
RECRUITING
Vandœuvre-lès-nancy
Germany
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Klinikum Ernst von Bergmann
RECRUITING
Potsdam
Hungary
Endomedix Kft.
RECRUITING
Budapest
Észak-Pesti Centrumkórház-Honvédkórház
RECRUITING
Budapest
Geomedical Orvosi Kft
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Vas-Oxy Egeszsegugyi Kft
RECRUITING
Szombathely
India
AIG Hospitals
RECRUITING
Gachibowli
SR Kalla Memorial Gastro & General Hospital
RECRUITING
Jaipur
Amrita Institute of Medical Sciences
RECRUITING
Kochi
MIDAS Multispeciality Hospital
RECRUITING
Nagpur (urban)
All India Institute Of Medical Sciences (AIIMS)
RECRUITING
New Delhi
Shree Giriraj Multispeciality Hospital
RECRUITING
Rajkot
Yashoda Hospitals
RECRUITING
Secunderabad
Gujarat Gastro and Vascular Hospital
RECRUITING
Surat
Surat Institute of Digestive Sciences Hospitals
RECRUITING
Surat
Israel
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
RECRUITING
Bologna
Asst Degli Spedali Civili Di Brescia
RECRUITING
Brescia
Ospedale Madonna delle Grazie
RECRUITING
Matera
IRCCS Ospedale San Raffaele
RECRUITING
Milan
IRCCS Ospedale Sacro Cuore Don Calabria
RECRUITING
Negrar
Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Policlinico Universitario Campus Biomedico Di Roma
RECRUITING
Rome
I.R.C.C.S Policlinico San Donato
RECRUITING
San Donato Milanese (mi)
Poland
Gastromed Kralisz, Romatowski, Stachurska sp.j.
RECRUITING
Bia?ystok
Medical Center Kermed
RECRUITING
Bydgoszcz
Szpital Miejski sw. Jana Paw?a II w Elblagu
RECRUITING
Elblag
Osrodek Badan Klinicznych Bd Research
RECRUITING
I?awa
MZ Badania Slowik Zymla Sp.j.
RECRUITING
Knurów
Centrum Medyczne Promed
RECRUITING
Krakow
Amicare Sp. z o.o. S.K.
RECRUITING
Lodz
Medrise sp z o.o
RECRUITING
Lublin
EMC Instytut Medyczny SA
RECRUITING
Późna
Gabinety Lekarskie Rivermed
RECRUITING
Późna
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
RECRUITING
Poznan
Endoskopia Sp. z o.o.
RECRUITING
Sopot
Sonomed Sp. z o.o.
RECRUITING
Szczecin
Centrum Zdrowia-MDM
RECRUITING
Warsaw
Medon Clinical Research sp. z o.o
RECRUITING
Warsaw
Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
RECRUITING
Warsaw
PlanetMed sp. z o.o.
RECRUITING
Wroc?aw
Portugal
Hospital de Braga
RECRUITING
Braga
Hospital de Santa Maria
RECRUITING
Lisbon
Hospital de Sao Joao
RECRUITING
Porto
Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
RECRUITING
Santa Maria Da Feira
Hospital Sao Teotonio
RECRUITING
Viseu
Romania
Spital Digenio - Centrul de Excelen?? în Afec?iuni Digestive
RECRUITING
Cluj-napoca
Slovakia
ABAWI spol. s r.o.
RECRUITING
Bratislava
KM Management spol. s r.o.
RECRUITING
Nitra
Spain
Fundacion Hospital de Alcorcon
RECRUITING
Alcorcón
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Clinico Univ. Lozano Blesa
RECRUITING
Zaragoza
United Kingdom
Fairfield General Hospital
RECRUITING
Bury
Bronglais General Hospital
RECRUITING
Llanrhystud
Royal London Hospital
RECRUITING
London
Contact Information
Primary
Reference Study ID Number: GA45332 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2033-04-30
Participants
Target number of participants: 425
Treatments
Experimental: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Placebo_comparator: Placebo
Participants will receive placebo IV followed by afimkibart SC injection.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical