CD is a chronic, progressive inflammatory disease of the gastrointestinal tract, characterized by periods of relapse and remission, which can ultimately lead to bowel damage and disability. Most patients present with an inflammatory phenotype, but over time, uncontrolled inflammation can lead to complications such as fibrotic strictures, fistula formation, or intestinal neoplasia (Torres et al. 2
Conditions
Interventions
Test group 1:500 mg IV at weeks 0, 2, 6, and 10, followed by 450mg SC every 4 weeks from week 12 to week 52 (Q4W)
Test group 2:500 mg IV at weeks 0, 2, 6, and 10, followed by 150 mg SCQ4W from week 12 to week 52
Placebo group:Placebo IV at weeks 0, 2, 6, and 10, followed by placebo SC Q4W from week 12 to week 52
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. General Inclusion Criteria (1) Signed Informed Consent Form (2) Signed Assent Form, when appropriate, as determined by the potential participant's age and individual site and country standards (3) Age>= 18 to =16 to = 40 kg; 2. Crohn's Disease-Specific Inclusion Criteria (1) Confirmed diagnosis of CD with supportive clinical, endoscopic and histopathological evidence (2) Moderately to severely active CD, meeting all of the following: – Centrally-read SES-CD of >=6 (or >= 4 for isolated ileal disease) – CDAI >=220 and 8 years or with risk factors for bowel cancer Any adenomatous polyps must be removed according to routine practice prior to their first dose of study drug. 3.Reproductive Inclusion Criteria (1) For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 95 days after the final dose of RO7790121. A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (=12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. The following are examples of adequate contraceptive methods: bilateral tubal ligation; male sterilization; hormonal contraceptives; hormone-releasing intrauterine devices; copper intrauterine devices; male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide. A male condom and a female condom should not be used together because of risk of failure due to friction. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. Female participants of childbearing potential must refrain from donating eggs or undergoing fertility treatment during this same period. (2) For male participants: ag
Exclusion criteria
Exclusion criteria: 1.Inflammatory Bowel Disease Exclusion Criteria ? Participant with a history of >= 3 bowel resections > 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum ? Diagnosis of short gut or short bowel syndrome ? Presence of ileostomy, colostomy, or ileo-anal pouch ? Patients with symptomatic bowel strictures, fulminant colitis, or toxic megacolon ? Current diagnosis of UC or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis ? Presence of abdominal or perianal abscess ? Presence of rectovaginal fistula or perianal fistulas with >3 openings and/or the anticipated need for perianal surgery during the study (except surgery for seton placement and/or removal) ? Current diagnosis or suspicion of primary sclerosing cholangitis; 2. Medical History Exclusion Criteria ? Lack of peripheral venous access ? Any major surgery within 6 weeks prior to screening or a major surgery planned during the study ?Any serious, chronic, and/or unstable preexisting medical, psychiatric, or other condition that could interfere with the potential participant's safety, provision of informed consent, or compliance with trial procedures ? Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 95 days after the final dose of RO7790121 Female participants of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test on Day 1 prior to initiation of study treatment. ? Any condition that would preclude endoscopic evaluation ?Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed ? History of malignancy within 5 years prior to screening visit, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer ? History of alcohol, drug, or chemical abuse < 1 year prior to screening; 3.Infection or Infection Risk Exclusion Criteria ? Any clinically significant infection <4 weeks prior to randomization that required hospitalization, IV antibiotics and did not resolve, or was opportunistic in nature ? Evidence of or treatment for Clostridioides difficile (C. difficile; formerly known as Clostridium difficile) as assessed by C. difficile toxin testing within 60 days prior to randomization (Day 1) or other enteric pathogens (as assessed by stool culture and ova and parasite evaluation) within 30 days prior to randomization (Day 1) ? Any diagnosis of CMV colitis in the past 60 days (including diagnosis during screening) Laboratory confirmation of CMV from a colon biopsy sample is required during screening evaluation only if clinical suspicion is high and to determine the need for CMV treatment. ? Positive HIV test at screening ? Positive test results for hepatitis B infection at screening, defined as meeting either of the following criteria: – Positive hepatitis B surface antigen (HBsAg) test at screening – Quantitative HBV DNA above the lower limit of quantification in patients with a negative hepatitis B surface antibody (HBsAb) test and positive total hepatitis B core antibody (HBcAb) test ? Positive hepatitis C virus (HCV) antibody test at screening ? Positive for tuberculosis (TB) during screening or within 3 months pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission, Endoscopic response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission, Endoscopic response;Endoscopic remission, Symptomatic remission;Symptomatic remission;Clinical remission, Endoscopic response;Clinical response,Symptomatic response;Symptomatic assessment;AE;Presence of draining fistulas; | — |
Countries
China
Contacts
Public ContactQian Cao
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed