Crohn's disease
Conditions
Interventions
RO7790121group:Induction period: 500 mg IV at weeks 0, 2, 6 and 10
OLE phase: 450 mg SC Q2W or Q4W
Intravenous infusion or subcutaneous injection.
Placebo Group:Intravenous infusion or subcutaneous injection of the same volume of placebo.
Sponsors
Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria Signed informed consent; Depending on the age of the potential subjects and the standards and national standards of each research center, sign the informed consent form as appropriate; Age >= 18 to = 16 to = 40 kg. Crohn's disease-specific inclusion criteria 1. Confirmed diagnosis of CD with supportive clinical, endoscopic, and histopathological evidence; 2. Have moderately to severely active CD and meet all of the following criteria: centrally interpreted SES-CD>= 6 (or for patients with isolated ileal disease, >= 4)- CDAI>= 220 and 8 years or with risk factors for bowel cancer undergoing a surveillance colonoscopy (performed according to local criteria) at screening or within 1 year prior to baseline to rule out the possibility of the presence of dysplasia Any adenomatous polyps must be removed as per routine practice prior to the first dose of study drug. Reproduction-related inclusion criteria 1. For female subjects of childbearing potential: agree to remain abstinent (refrain from sexual intercourse with the opposite sex) or use adequate contraception for the duration of treatment and for 95 days after the last dose of RO7790121, and agree to refrain from egg donation or undergo fertility treatment. Female subjects are considered to be of childbearing potential if they are postmenarche, have not yet reached postmenopausal status (continuous amenorrhea>= 12 months, and have no cause other than menopause), and have not undergone permanent sterilization surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or have no other cause determined by the investigator (e.g., Miller's duct hypoplasia). According to this definition, female subjects undergoing tubal ligation are considered to be of childbearing potential. The definition of childbearing potential can be adjusted to align with local guidelines or regulations. The following are examples of adequate contraception: bilateral tubal ligation; male sterilization; hormonal contraceptives; intrauterine devices that release hormones; copper-containing intrauterine devices; male or female condoms with or without spermicide; and contraceptive caps, diaphragms, or sponges containing spermicide. Male and female condoms should not be used together because of the risk of contraceptive failure due to friction. The reliability of abstinence should be assessed in the context of clinical trial duration, participant preference, and lifestyle of daily living. Periodic abstinence (e.g., calendar day, ovulation, basal body temperature, or post-ovulation contraception) and in vitro ejaculation are not reliable methods of contraception. If required by local guidelines or regulations, state locally recognized appropriate contraceptive methods and information on the reliability of abstinence in the local informed consent form. Female subjects of childbearing potential must not donate eggs or undergo fertility treatm
Exclusion criteria
Exclusion criteria: 1. Subject has a history of > = 3 bowel resections Missing from the following 5 intestinal segments> 2 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid colon and left colon, and rectum; 2. Diagnosis of short bowel or short bowel syndrome; 3. Have undergone ileostomy, colostomy or ileal pouch anal anastomosis; 4. Patients with symptomatic intestinal stenosis, fulminant colitis or toxic megacolon; 5. Current diagnosis of UC, amorphous colitis, ischemic colitis, infectious colitis, radiation colitis, or microscopic colitis; 6. Presence of abdominal or perianal abscess; 7. Presence of rectovaginal fistulas or perianal fistulas with an open > 3 and/or anticipation of the need for perianal surgery during the study (except for surgery to place and/or remove the string of sutures); 8. Current diagnosis or suspicion of primary sclerosing cholangitis; 9. No peripheral venous access; 10. Any major surgery within 6 weeks prior to screening or planned major surgery during the study; 11. Any severe, chronic, and/or unstable pre-existing medical, psychiatric or other illness that may interfere with the safety of potential subjects, the provision of informed consent, or compliance with trial procedures; 12. Be pregnant or lactating, or plan to become pregnant during the study or within 95 days after the last dose of RO7790121; 13. Any condition that may preclude endoscopic evaluation; 14. Previous or current evidence of the presence of definite low- or high-grade colonic dysplasia or adenoma or new organisms that have not been completely resected; 15. History of malignant tumors within 5 years prior to the screening visit, except for non-metastatic basal cell carcinoma or squamous cell carcinoma or cervical cancer in situ that has undergone adequate resection therapy; 16. History of alcohol, drug or chemical abuse within =2.5 × upper limit of normal (ULN), total bilirubin >=2 × ULN, or the presence of abnormal liver synthetic function examination judged by the investigator to be clinically significant; 28.ANC < 1.5 × 10^9/L(1500/µL); 29. Platelet count< 100,000/µL; 30. Hemoglobin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission; | — |
Countries
China
Contacts
Public ContactHong Yang
Peking Union Medical College Hospital Chinese Academy of Medical Sciences
Outcome results
None listed