Ulcerative Colitis
Conditions
Interventions
RO7790121 Group:Intravenous infusion/Subcutaneous injection of RO7790121
Placebo Group:Intravenous infusion/Subcutaneous injection of placebo
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: General selection criteria: Sign the informed consent form; According to the age of potential participants and the standards of each research center and national standards, sign informed consent forms for minors as appropriate; Age >= 18 to = 16 to= 40 kg; Specific inclusion criteria for ulcerative colitis: Diagnosed with UC and supported by clinical, endoscopic, and histopathological evidence; Through endoscopic examination (flexible sigmoidoscopy or colonoscopy), if the distance from the anal margin is measured to be >= 15 cm, it is confirmed to be active UC; At baseline, no more than 10% of the total enrolled subjects had only proctitis. Moderate to severe active UC, defined as an mMS score of 5-9, including a Mayo endoscopic score (ES) of 2 or 3, confirmed by central interpretation of endoscopic examination results performed in the following: During the screening period Before the screening period (unrelated to the study), within 2 weeks before screening, and among patients diagnosed with UC. If endoscopic examination is performed before screening, there must be available video footage in a format suitable for central interpretation. The results of previous endoscopic examinations can only be used for screening in accordance with the endoscopic procedure manual/protocol specifications. Subjects with a pan colitis course>8 years and subjects with a left-sided colitis course>12 years must have undergone monitoring colonoscopy (according to local standards) within 2 years prior to baseline to rule out the possibility of dysplasia. Subjects who have not undergone monitoring colonoscopy in the past 2 years must be willing to undergo colonoscopy during screening (i.e., not flexible sigmoidoscopy). Any adenomatous polyp must be removed according to routine practice before the first administration of the study drug. Inclusion criteria related to reproduction: For female subjects with fertility: agree to maintain abstinence (avoid heterosexual intercourse) or take adequate contraceptive measures during the treatment period and for 95 days after the last dose of RO7790121; If a female subject is in the late menopausal period, has not yet reached a postmenopausal state (continuous amenorrhea for >= 12 months, and for no other reason other than menopause), and has not undergone permanent sterilization surgery (i.e. removal of ovaries, fallopian tubes, and/or uterus) or other reasons determined by the researcher (such as Miller's tube hypoplasia) leading to permanent infertility, she is considered to have fertility. According to this definition, female subjects who undergo tubal ligation are considered to have fertility. The definition of having fertility can be adjusted to align with local guidelines or regulations. The following are examples of appropriate contraceptive measures: bilateral tubal ligation; Male sterilization; Hormonal contraceptives; Intrauterine devices that release hormones; Copper containing intrauterine device; Male or female condoms with or without spermicide; And contraceptive caps, diaphragms, or sponges containing spermicides. Male and female condoms should not be used simultaneously, as there is a risk of contraceptive failure due to friction. The reliability of abstinence should be evaluated based on the duration of clinical trials, subject preferen
Exclusion criteria
Exclusion criteria: Exclusion criteria related to inflammatory bowel disease: Severe UC, as evidenced by any of the following: hospitalization for UC treatment within <= 2 weeks prior to screening, or at the discretion of the physician, hospitalization for any type of UC medical care or surgical intervention (such as colectomy) may be necessary during the study period. There is currently evidence of fulminant colitis, toxic megacolon, or a recent history of toxic megacolon or intestinal perforation (within 6 months). Previously undergone extensive colectomy, subtotal colectomy, or total colectomy, or planned to undergo UC surgery during the study period. The current diagnosis is Crohn's disease (CD), intra-abdominal/intra-abdominal/perianal fistula and/or abscess, indeterminate colitis, unclassified IBD, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticulosis. Having a stoma or wearing a ileal anal pouch; Currently diagnosed or suspected of primary sclerosing cholangitis. Exclusion criteria related to medical history: No peripheral venous access; Any major surgery performed or planned during the study period within the 6 weeks prior to screening. Any serious, chronic, and/or unstable pre-existing medical, mental illness, or other disease that may interfere with the safety, informed consent, or adherence to trial procedures of potential subjects; Female subjects who are pregnant or breastfeeding, or planning to become pregnant and have fertility within 95 days after the last administration of RO7790121 during the study period, must have a negative serum pregnancy test result during screening, and a negative urine pregnancy test result on the first day before starting study treatment. Any condition that may hinder endoscopic evaluation; Previous or current evidence suggests the presence of clear low-grade or high-grade colonic dysplasia, adenoma, or incompletely resected tumor; A history of malignant tumors within the past 5 years prior to the screening visit, except for non metastatic basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ that has undergone sufficient resection treatment; History of alcohol, drug, or chemical abuse within<1 year prior to screening; Exclusion criteria related to infection or infection risk: Any clinically significant or opportunistic infections that require hospitalization, IV antibiotics, or have not fully recovered within<3 months prior to randomization; Within 60 days prior to randomization (Day 1), there was C. difficile (formerly known as Clostridium difficile) present through C. difficile Evidence of infection or treatment with difficile toxin testing evaluation, or evidence of infection or treatment with other intestinal pathogens (evaluated through fecal culture and evaluation of eggs and parasites) within 30 days prior to randomization (Day 1); Diagnosed with cytomegalovirus (CMV) colitis within the past 60 days (including screening period); Only when there is a high suspicion of CMV in clinical practice and it is determined whether treatment is needed, colon biopsy samples need to be used for laboratory testing to confirm CMV during screening and evaluation; The HIV test result was positive during screening; A positive result for hepatitis B infection during screening is defined as meeting any of the following criteria: a positive result for hepatitis B surface antigen (HbsAg) during screening; The quantitative HBV DNA of patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| pmMS from baseline to week 2;Endoscopic improvement ;Endoscopic relief;Histology Endoscopic Mucosal Improvement;Histology Endoscopic Relief;FACIT-F;IBQD;PGIS; | — |
Countries
China
Contacts
Public ContactBaili Chen
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed