Phase
Condition
N/ATreatment
RO7790121
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 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
Past or current evidence of definite low-grade or high-grade colonic dysplasia oradenomas or neoplasia not completely removed
History of malignancy within 5 years, with the exception of malignancies adequatelytreated with resection for non-metastatic basal cell or squamous cell cancer or insitu 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)
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
London Health Sciences Centre Uni Campus
London, Ontario N6A 5A5
CanadaActive - 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
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
Huizhou First Hospital
Huizhou,
ChinaActive - Recruiting
Jinhua municipal central hospital
Jinhua,
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
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
ChinaActive - Recruiting
Hospital Universitario San Ignacio
Bogota, 000472
ColombiaActive - Recruiting
Oncomedica S.A.
Monteria, 230002
ColombiaActive - Recruiting
CHU Clermont Ferrand - Hôtel Dieu
Clermont-Ferrand, 63000
FranceActive - Recruiting
Hopital Dupuytren
Limoges, 87042
FranceActive - Recruiting
Hopital Saint-Eloi
Montpellier, 34295
FranceActive - Recruiting
Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
Pozna?, 61-731
PolandActive - Recruiting
Centrum Zdrowia-MDM
Warszawa, 00-189
PolandActive - Recruiting
Royal London Hospital
London, E1 1FR
United KingdomActive - Recruiting
Om Research LLC
Lancaster, California 93534
United StatesActive - Recruiting
J&A Clinical Research
Doral, Florida 33173
United StatesActive - Recruiting
Allied Biomedical Research Institute, Inc
Miami, Florida 33155
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
Charlotte Gastroenterology and Hepatology, P.L.L.C
Charlotte, North Carolina 28207
United StatesActive - Recruiting
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