Phase
Condition
N/ATreatment
RO7790121
Afimkibart
Placebo
Clinical Study ID
Ages 16-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 leastone protocol-specified conventional or advanced CD therapy
Males and females of childbearing potential must meet protocol criteria forcontraception requirements
Exclusion
Exclusion Criteria:
Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemiccolitis, infectious colitis, radiation colitis, microscopic colitis
Participant with a history of >= 3 bowel resections (> 2 missing segments of the 5following segments: terminal ilelium, right colon, transverse colon, sigmoid andleft 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 toxicmegacolon
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 toxicmegacolon
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-gradeor high-grade colonic dysplasia
History of non-gastrointestinal cancer, with the exception of adequately treatednon-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer
Evidence of infection with Clostridioides difficile (C. difficile; formerly known asClostridium 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 (perlocal guidance) or inadequately treated TB
Has received protocol-specified prohibited medicines, including known exposure toany type of anti-TL1A therapy
Study Design
Connect with a study center
Macquarie University Hospital
Macquarie Park, New South Wales 2109
AustraliaActive - Recruiting
Coral Sea Clinical Research Institute
Mackay, Queensland 4740
AustraliaActive - Recruiting
Klinikum Wels-Grieskirchen
Wels, 4600
AustriaActive - Recruiting
UZ Brussel
Brussel, 1090
BelgiumActive - Recruiting
CHU St Pierre (St Pierre)
Brussels, 1000
BelgiumActive - Recruiting
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
Barrie GI Associates
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
London Health Sciences Centre Uni Campus
London, Ontario N6A 5A5
CanadaActive - Recruiting
Toronto Immune and Digestive Health Institute
North York, Ontario M6A 3B4
CanadaActive - Recruiting
Centro de Investigación Clínica UC-CICUC
Santiago, 8330034
ChileActive - Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi 341000
ChinaActive - Recruiting
The First Affilliated Hospital of Kunming Medical University
Kunming, Yunnan 650032
ChinaActive - Recruiting
Jinhua municipal central hospital
Jinhua, Zhejiang 321013
ChinaActive - Recruiting
Beijing Union Hospital
Beijing, 100730
ChinaActive - Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
ChinaActive - Recruiting
Guangzhou First People's Hospital
Guangzhou, 510180
ChinaActive - Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, 510280
ChinaActive - Recruiting
Hainan General Hospital
Haikou, 570311
ChinaActive - Recruiting
Huizhou First Hospital
Huizhou,
ChinaActive - Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang City, 330008
ChinaActive - Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
ChinaActive - Recruiting
Shengjing Hospital of China Medical University
ShenYang, 110004
ChinaActive - Recruiting
Hebei Medical University - The Second Hospital
Shijiazhuang City, 050004
ChinaActive - Recruiting
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi'an City, 710004
ChinaActive - Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
ChinaActive - Recruiting
Hospital Universitario San Ignacio
Bogota, 000472
ColombiaActive - Recruiting
Oncomedica S.A.
Monteria, 230002
ColombiaActive - Recruiting
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, 500 12
CzechiaActive - Recruiting
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52
CzechiaActive - Recruiting
ISCARE a.s.
Praha 7, 170 04
CzechiaActive - Recruiting
CHU Tours - Hôpital Trousseau
Chambray les Tours, 37170
FranceActive - Recruiting
CHU Clermont Ferrand - Hôpital d'Estaing
Clermont Ferrand, 63000
FranceActive - Recruiting
CHU Clermont Ferrand - Hôtel Dieu
Clermont-Ferrand, 63000
FranceSite Not Available
Hôpital Henri Mondor
Créteil, 94000
FranceActive - Recruiting
CH Dptal Les Oudairies
La Roche Sur Yon, 85925
FranceActive - Recruiting
CHRU de Lille - Hopital Claude Huriez
Lille, 59037
FranceActive - Recruiting
Hopital Dupuytren
Limoges, 87042
FranceActive - Recruiting
Hopital Saint-Eloi
Montpellier, 34295
FranceActive - Recruiting
Institut des MICI, Clinique Ambroise Paré
Neuilly sur Seine, 92200
FranceActive - Recruiting
Hôpital Saint-Louis
Paris, 75475
FranceActive - Recruiting
Centre Hospitalier Lyon Sud
Pierre-Benite, 69495
FranceActive - Recruiting
Hôpital de Brabois Adultes
Vandoeuvre-les-nancy, 54511
FranceActive - Recruiting
Vas-Oxy Egeszsegugyi Kft
Szombathely, 9700
HungaryActive - Recruiting
Policlinico Universitario Agostino Gemelli
Roma, Lazio 00168
ItalyActive - Recruiting
Policlinico Universitario Campus Biomedico Di Roma
Roma, Lazio 00128
ItalyActive - Recruiting
Medical Center Kermed
Bydgoszcz, 85-231
PolandActive - Recruiting
MZ Badania Slowik Zymla Sp.j.
Knurów, 44-190
PolandActive - Recruiting
Centrum Medyczne Promed
Kraków, 31-513
PolandActive - Recruiting
Medrise sp z o.o
Lublin, 20-582
PolandActive - Recruiting
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Pozna?, 61-731
PolandActive - Recruiting
Gabinety Lekarskie Rivermed
Pozna?, 61-441
PolandActive - Recruiting
Endoskopia Sp. z o.o.
Sopot, 81-756
PolandActive - Recruiting
Centrum Zdrowia-MDM
Warszawa, 00-189
PolandActive - Recruiting
PlanetMed sp. z o.o.
Wroc?aw, 52-210
PolandActive - Recruiting
Hospital de Braga
Braga, 4710-243
PortugalActive - Recruiting
Hospital de Santa Maria
Lisboa, 1649-035
PortugalActive - Recruiting
Hospital de Sao Joao
Porto, 4202-451
PortugalActive - Recruiting
Hospital Clinico Univ. Lozano Blesa
Zaragoza, 50009
SpainActive - Recruiting
Fairfield General Hospital
Bury, BL9 7TD
United KingdomActive - Recruiting
Bronglais General Hospital
Llanrhystud, SY23 1ER
United KingdomActive - Recruiting
Royal London Hospital
London, E1 1FR
United KingdomActive - Recruiting
Om Research LLC
Lancaster, California 93534
United StatesActive - Recruiting
Amicis Research Center
Santa Clarita, California 91355
United StatesActive - Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
J&A Clinical Research
Doral, Florida 33173
United StatesActive - Recruiting
Allied Biomedical Research Institute, Inc
Miami, Florida 33155
United StatesActive - Recruiting
Homestead Associates in Research, Inc.
Miami, Florida 33033
United StatesActive - Recruiting
Miami Beach Clinical Research Center
Miami Beach, Florida 33141
United StatesActive - Recruiting
Eminat Research Group
Miramar, Florida 33027
United StatesActive - Recruiting
Digestive and Liver Center of Florida
Orlando, Florida 32825
United StatesActive - Recruiting
Louisiana Research Center - GastroIntestinal Associates
Shreveport, Louisiana 71105
United StatesActive - Recruiting
Mercy Medical Center
Baltimore, Maryland 21202
United StatesActive - Recruiting
Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
United StatesActive - Recruiting
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan 49519
United StatesActive - Recruiting
Ellipsis Research Group
Brooklyn, New York 11215
United StatesActive - Recruiting
Intercity Gastroenterology
Fresh Meadows, New York 11366
United StatesActive - Recruiting
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Clinical Inquest Center
Beavercreek, Ohio 45431
United StatesActive - Recruiting
GI Alliance
Garland, Texas 75044
United StatesActive - Recruiting
Carta - Clinical Associates In Research Therapeutics Of America;LLC
San Antonio, Texas 78212
United StatesActive - Recruiting
University of Texas Health Center at Tyler
Tyler, Texas 75708
United StatesActive - Recruiting
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