A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease
Status: Recruiting
Location: See all (301) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance 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
Alabama
Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
RECRUITING
Dothan
Arizona
Mayo Clinic Hospital
RECRUITING
Phoenix
Arizona Digestive Health, P.C (ADH)
RECRUITING
Sun City
California
Valley View Internal Medicine
RECRUITING
Garden Grove
310 Clinical Research
RECRUITING
Inglewood
UCSD Medical Center
RECRUITING
La Jolla
Gastro Care Associates
RECRUITING
Lancaster
Om Research LLC
RECRUITING
Lancaster
United Gastroenterologists
RECRUITING
Los Alamitos
Acclaim Clinical Research, Inc.
RECRUITING
San Diego
Kaiser Permanente
RECRUITING
San Francisco
UCSF/Medical Center at Mount Zion
RECRUITING
San Francisco
Colorado
Rocky Mountain Gastroenterology
RECRUITING
Littleton
Peak Gastroenterology Surgery Center
RECRUITING
Lone Tree
Florida
Access Research Institute
RECRUITING
Brooksville
Gastro Florida
RECRUITING
Clearwater
HealthMed Clinical Center Inc.
RECRUITING
Coral Gables
Hi Tech and Global Research, LLC
RECRUITING
Coral Gables
NeoClinical Research
RECRUITING
Hialeah
The Sister Life Research
RECRUITING
Hialeah
Clinical Research of Osceola, LLC
RECRUITING
Kissimmee
Florida Research Institute - Lakewood
RECRUITING
Lakewood Rch
Ambert Medical Research
RECRUITING
Miami
LCC Medical Research Institute, LLC
RECRUITING
Miami
Orlando Regional Healthcare
RECRUITING
Orlando
Guardian Angel Research Center, LLC
RECRUITING
Tampa
Nodal Medical Center Research - NMC
RECRUITING
Tampa
University of South Florida School of Medicine Morsani Center for Advanced Health Care
RECRUITING
Tampa
Theia Clinical Research Centers, LLC
RECRUITING
Temple Terrace
Florida Medical Clinic - Orlando Health
RECRUITING
Zephyrhills
Georgia
Atlanta Gastroenterology Associates
RECRUITING
Atlanta
Digestive Healthcare of Georgia
RECRUITING
Atlanta
Gastroenterology Associates of Central Georgia
RECRUITING
Macon
Idaho
Grand Teton Research Group, PLLC
RECRUITING
Idaho Falls
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Illinois Gastroenterology Group-Glenview powered by GI Alliance
RECRUITING
Glenview
GI Alliance - Gurnee
RECRUITING
Gurnee
Indiana
Indiana University Health University Hospital
RECRUITING
Indianapolis
Gastroenterology Health Partners, PLLC
RECRUITING
New Albany
Kansas
Kansas Gastroenterology, LLC under Clinical Trials Network
RECRUITING
Wichita
Kentucky
Tri-State Gastroenterology Associates
RECRUITING
Crestview Hills
Gastroenterology Health Partners, PLLC
RECRUITING
Louisville
Massachusetts
Boston University
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Michigan
Michigan Center of Medical Research
RECRUITING
Farmington Hills
Mississippi
Gastroenterology Associates and Endoscopy Center of North Mississippi
RECRUITING
Oxford
Delta Gastroenterology & Endoscopy Center
RECRUITING
Southaven
North Carolina
Atrium Health, Carolinas Healthcare System
RECRUITING
Charlotte
Omega Research North Carolina, LLC
RECRUITING
Fuquay-varina
Monroe Biomedical Research
RECRUITING
Monroe
Nevada
Las Vegas Clinical Trials, LLC
RECRUITING
North Las Vegas
New York
Lenox Hill Hospital
RECRUITING
New York
Mount Sinai Hospital - IBD Clinical Center
RECRUITING
New York
DiGiovanna Inst for Med Ed&Res
RECRUITING
North Massapequa
Queens Village Medical Care
RECRUITING
Queens Village
Mainstreet - Richmond Hill Clinic
RECRUITING
Richmond Hill
Gastroenterology Group Of Rochester, LLP
RECRUITING
Rochester
Ohio
Dayton Gastroenterology, Inc.
RECRUITING
Beavercreek
Digestive Disease Consultants
RECRUITING
Brunswick
University of Cincinnati Hospital
RECRUITING
Cincinnati
Ohio Gastroenterology Group
RECRUITING
Columbus
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Gastro Health- Liberty
RECRUITING
Liberty Township
Gastro Intestinal Research Institute of Northern Ohio
RECRUITING
Westlake
Oklahoma
Central Sooner Research
RECRUITING
Norman
Pennsylvania
Frontier Clinical Re search, LLC
RECRUITING
Uniontown
Rhode Island
University Gastroenterology
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Gastroenterology Associates
RECRUITING
Greenville
Tennessee
Gastro One
RECRUITING
Germantown
Quality Medical Research
RECRUITING
Nashville
Texas
Texas Clinical Research Institute, LLC
RECRUITING
Arlington
Proactive El Paso,LLC
RECRUITING
El Paso
UTMB Galveston Campus
RECRUITING
Galveston
Amel Med LLC
RECRUITING
Georgetown
Cano Medical Center
RECRUITING
Harlingen
TDDC dba GI Alliance Research
RECRUITING
Mansfield
SMS Clinical Research, LLC
RECRUITING
Mesquite
Gastroenterology Research of America, LLC
RECRUITING
San Antonio
GI Alliance - Southlake
RECRUITING
Southlake
Baylor Scott and White Medical Center
RECRUITING
Temple
Tyler Research Institute, LLC
RECRUITING
Tyler
Virginia
Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
RECRUITING
Chesapeake
Emeritas Research Group
RECRUITING
Lansdowne Town Center
Blue Ridge Medical Research - Gastroenterology Associates of Central Virginia
RECRUITING
Lynchburg
Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
RECRUITING
Roanoke
Tidewater Physicians Multispecialty Group (TPMG) - Clinical Research Division - Williamsburg
RECRUITING
Williamsburg
Washington
The Vancouver Clinic
RECRUITING
Vancouver
Other Locations
Argentina
Hospital Britanico
RECRUITING
Ciudad Autonoma Bs As
Hospital Provincial del Centenario
RECRUITING
Rosario
Australia
Lyell McEwin Hospital
RECRUITING
Adelaide
Northern Hospital
RECRUITING
Epping
The Canberra Hospital
RECRUITING
Garran
Mater Misericordiae Limited
RECRUITING
South Brisbane
Royal Prince Alfred Hospital
RECRUITING
Sydney
Austria
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Barmherzige Brüder Wien
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
AZORG Campus Aalst-Moorselbaan
RECRUITING
Aalst
Cliniques Universitaires St-Luc
RECRUITING
Brussels
UZ Antwerpen
RECRUITING
Edegem
AZ Maria Middelares
RECRUITING
Ghent
AZ Sint Lucas (Sint Lucas)
RECRUITING
Ghent
Jessa Zkh (Campus Virga Jesse)
RECRUITING
Hasselt
CHC MontLégia
RECRUITING
Liège
CHU de Liège (Sart Tilman)
RECRUITING
Liège
CHU HELORA - Hôpital de Mons - Site Kennedy
RECRUITING
Mons
Vitaz
RECRUITING
Sint-niklaas
Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
RECRUITING
Botucatu
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
RECRUITING
Brasília
Centro de Pesquisa São Lucas
RECRUITING
Campinas
Centro Digestivo de Curitiba
RECRUITING
Curitiba
Hospital de Clinicas de Porto Alegre X
RECRUITING
Porto Alegre
BR Trials - Pesquisa Clínica
RECRUITING
São Paulo
CPQuali Pesquisa Clinica Ltda
RECRUITING
São Paulo
Bulgaria
MHAT St. Ivan Rilski
RECRUITING
Gorna Oryahovitsa
MHAT Saint Karidad EAD
RECRUITING
Plovdiv
Canada
South Edmonton Gastroenterology
RECRUITING
Edmonton
C.I.C. Mauricie
RECRUITING
Trois-rivières
Chile
Hospital Guillermo Grant Benavente
RECRUITING
Concepción
Clinica Universidad de Los Andes
RECRUITING
Santiago
Medwal
RECRUITING
Santiago
China
Peking University Third Hospital
RECRUITING
Beijing
the First Hospital of Jilin University
RECRUITING
Changchun
Third Xiangya Hospital Centrel South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing General Hospital
RECRUITING
Chongqing
The First Affiliated Hospital Of Fujian Medical University
RECRUITING
Fuzhou
The second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The sixth affiliated hospital of Sun Yat-Sen University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University
RECRUITING
Hangzhou
Zhejiang Province Traditional Chinese Medical Hospital
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Huizhou Central People's Hospital
RECRUITING
Huizhou
The 1st Affiliated Hospital of Nanchang Unversity
RECRUITING
Nanchang
The First Affiliate Hospital of Guangxi Medical University
RECRUITING
Nanning
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
Shanghai East Hospital
RECRUITING
Shanghai
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
Taizhou Hospital Of Zhejiang Province
RECRUITING
Taizhou
Ren Min Hospital Affiliated Wu Han University
RECRUITING
Wuhan
The Central Hospital of Wuhan
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
The Second Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Zhuzhou Central Hospital
RECRUITING
Zhuzhou
Colombia
Clinica del Country
RECRUITING
Bogotá
Hospital Pablo Tobon Uribe
RECRUITING
Medellín
Croatia
Borzan Polyclinic
RECRUITING
Osijek
Denmark
Herlev Hospital
RECRUITING
Herlev
Dominican Republic
CEMDOE (Centro Médico de Diabetes, Obesidad y Especialidades)
RECRUITING
Santo Domingo
France
CHU Amiens - Hopital Sud
RECRUITING
Amiens
Hopital Nord
RECRUITING
Marseille
CHU Nice - Hopital de l'Archet 2
RECRUITING
Nice
CHU Bordeaux - Hôpital Haut-Lévêque
RECRUITING
Pessac
Hopital Robert Debre
RECRUITING
Reims
CHU de Rennes - Hopital de Pontchaillo
RECRUITING
Rennes
CHU Saint Etienne - Hôpital Nord
RECRUITING
Saint-etienne
Germany
Charite - Campus Benjamin Franklin
RECRUITING
Berlin
AGAPLESION Markus-Krankenhaus
RECRUITING
Frankfurt
Klinik Johann Wolfgang von Goethe Uni
RECRUITING
Frankfurt
Universitaetsklinikum Halle (Saale)
RECRUITING
Halle
Med. Hochschule Hannover
RECRUITING
Hanover
Universitaetsklinikum Jena
RECRUITING
Jena
Klinikum Mannheim GmbH Universitätsklinikum
RECRUITING
Mannheim
Universitätsklinikum Ulm
RECRUITING
Ulm
Guatemala
Celan S.A.
RECRUITING
Guatemala City
Medi-k
RECRUITING
Guatemala City
Hungary
Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
RECRUITING
Békéscsaba
Obudai Egeszsegugyi Centrum Kft.
RECRUITING
Budapest
Pannonia Maganorvosi Centrum
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Clinexpert Gyongyos Kft
RECRUITING
Gyöngyös
Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
RECRUITING
Székesfehérvár
Clinfan Szolgaltato Kft.
RECRUITING
Szekszárd
India
AIG Hospitals
RECRUITING
Gachibowli
SR Kalla Memorial Gastro & General Hospital
RECRUITING
Jaipur
Amrita Institute of Medical Sciences
RECRUITING
Kochi
Shree Giriraj Multispeciality Hospital
RECRUITING
Rajkot
Yashoda Hospitals
RECRUITING
Secunderabad
Israel
Soroka University Medical Centre
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro
RECRUITING
Catanzaro
Asst Santi Paolo E Carlo
RECRUITING
Milan
Azienda Ospedaliero - Universitaria di Cagliari
RECRUITING
Monserrato
Universita'degli Studi di Napoli Federico II
RECRUITING
Napoli
Fondazione IRCCS Policlinico San Matteo di Pavia
RECRUITING
Pavia
ASST Rhodense - Ospedale di Rho
RECRUITING
Rho
Ospedale Isola Tiberina Gemelli
RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano (mi)
IRCCS Ospedale Casa Sollievo della Soffenza
RECRUITING
San Giovanni Rotondo
Ospedale Mauriziano Umberto I
RECRUITING
Turin
Japan
Gamagori City Hospital
RECRUITING
Aichi
Nagoya City University Hospital
RECRUITING
Aichi
National Hospital Organization Hirosaki General Medical Center
RECRUITING
Aomori
Asahikawa City Hospital
RECRUITING
Asahikawa-shi
Asahikawa Medical University Hospital
RECRUITING
Asahikawa-shi
Tsujinaka Hospital Kashiwanoha
RECRUITING
Chiba
Fukuoka University Chikushi Hospital
RECRUITING
Chikushino-shi
Ehime Prefectural Central Hospital
RECRUITING
Ehime
Fukui Prefectural Hospital
RECRUITING
Fukui
Fukuoka University Hospital
RECRUITING
Fukuoka
Kitakyushu Municipal Medical Center
RECRUITING
Fukuoka
Kurume University Hospital
RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center
RECRUITING
Fukuoka
Hiroshima Prefectural Hospital
RECRUITING
Hiroshima
Hiroshima University Hospital
RECRUITING
Hiroshima
Medical Corporation Sapporo IBD Clinic
RECRUITING
Hokkaido
Sapporo Kosei General Hospital
RECRUITING
Hokkaido
Sapporo Medical University Hospital
RECRUITING
Hokkaido
Hyogo Medical University Hospital
RECRUITING
Hyōgo
Ishikawa Prefectural Central Hospital
RECRUITING
Ishikawa
Kagawa Prefectural Central Hospital
RECRUITING
Kagawa
Sameshima Hospital
RECRUITING
Kagoshima
Gokeikai Ofuna Chuo Hospital
RECRUITING
Kanagawa
Yokohama City University Medical Center
RECRUITING
Kanagawa
Japanese Red Cross Kumamoto Hospital
RECRUITING
Kumamoto
Sendai Medical Center
RECRUITING
Miyagi
Nagasaki University Hospital
RECRUITING
Nagasaki
Okayama University Hospital
RECRUITING
Okayama
Kinshukai Infusion Clinic
RECRUITING
Osaka
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Saga University Hospital
RECRUITING
Saga
Saga-ken Medical Centre Koseikan
RECRUITING
Saga
Takagi clinic
RECRUITING
Sendai
Matsuda Hospital
RECRUITING
Shizuoka
National Hospital Organization Shizuoka Medical Center
RECRUITING
Shizuoka
Takamatsu Red Cross Hospital
RECRUITING
Takamatsu
Institute of Science Tokyo Hospital
RECRUITING
Tokyo
JCHO Tokyo Yamate Medical Center
RECRUITING
Tokyo
National Center for Global Health and Medicine
RECRUITING
Tokyo
Tokyo Metropolitan Bokutoh Hospital
RECRUITING
Tokyo
Toyama University Hospital
RECRUITING
Toyama
Japanese Red Cross Wakayama Medical Center
RECRUITING
Wakayama
Yamagata University Hospital
RECRUITING
Yamagata
Yamanashi Prefectural Central Hospital
RECRUITING
Yamanashi
Mexico
Boca Clinical Trials Mexico S.C. (Guadalajara)
RECRUITING
Guadalajara
Medical Care & Research SA de CV
RECRUITING
Mérida
Hospital General de Mexico
RECRUITING
Mexico
Netherlands
ETZ Elisabeth
RECRUITING
Tilburg
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Poland
Clinical Trials UMED Sp. z o. o.
RECRUITING
?ód?
Centrum Medyczne Medis
RECRUITING
Bydgoszcz
Centrum Medyczne Lukamed Joanna Luka-Wendrowska
RECRUITING
Chojnice
Endo-Med Sp. z o.o.
RECRUITING
Karczew
Krakowskie Centrum Medyczne - Part of Futuremeds
RECRUITING
Krakow
Allmedica Badania Kliniczne Sp z o.o. Sp K.
RECRUITING
Nowy Targ
Wojewodzki Specjalistyczny Szpital w Olsztynie
RECRUITING
Olsztyn
NZOZ Eskulap Pabianice
RECRUITING
Pabianice
SOLUMED Centrum Medyczne
RECRUITING
Późna
Centrum Medyczne MEDYK
RECRUITING
Rzeszów
Gastromed Sp. z o.o.
RECRUITING
Toru?
Centralny Szpital Kliniczny MSW w Warszawie
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Melita Medical
RECRUITING
Wroc?aw
Przychodnia EuroMediCare
RECRUITING
Wroc?aw
Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
RECRUITING
Wroc?aw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
ETG Zamosc
RECRUITING
Zamość
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
Puerto Rico
Klinical Investigations Group LLC
RECRUITING
San Juan
University of Puerto Rico Medical Sciences Campus
RECRUITING
San Juan
Serbia
University Hospital Center Dr Dragisa Misovic - Dedinje
RECRUITING
Belgrade
University Hospital Medical Center Zvezdara
RECRUITING
Belgrade
Clinical Center of Vojvodina
RECRUITING
Novi Sad
Slovakia
Cliniq s.r.o.
RECRUITING
Bratislava
Endomed, s.r.o.
RECRUITING
Košice
Ustredna vojenska nemocnica SNP Ruzomberok ? FN
RECRUITING
Ružomberok
Spain
Hospital de Galdakao
RECRUITING
Galdacao
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Reina Sofía
RECRUITING
Murcia
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Taiwan
E-Da Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Chung Shan Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Thailand
Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
RECRUITING
Bangkok
Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
RECRUITING
Bangkok
Khon Kaen Uni
RECRUITING
Khon Kaen
Thammasat University Hospital
RECRUITING
Pathum Thani
Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
RECRUITING
Songkhla
United Arab Emirates
Burjeel Hopital
RECRUITING
Abu Dhabi
Sheikh Khalifa Medical City (SKMC)
RECRUITING
Abu Dhabi
Sheikh Shakhbout Medical City
RECRUITING
Abu Dhabi
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
St Mark's Hospital & Imperial College
RECRUITING
Harrow
Royal Liverpool University Hospital
RECRUITING
Liverpool
King College Hospital NHS Foundation Trust
RECRUITING
London
Queen Anne Street Medical Centre
RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
North Tyneside General Hospital
RECRUITING
North Shields
Nottingham University Hospitals Queen's Medical Centre
RECRUITING
Nottingham
Contact Information
Primary
Reference Study ID Number: GA45331 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2033-12-31
Participants
Target number of participants: 600
Treatments
Experimental: Arm 1: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.
Experimental: Arm 2: Afimkibart
Participants will receive afimkibart IV followed by afimkibart SC injection.
Placebo_comparator: Arm 3: Placebo
Participants will receive placebo IV followed by placebo SC.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical