Moderately to severely active ulcerative colitis (UC)
Conditions
Interventions
Experimental group:RO7790121
Control group:placebo
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Selection Criteria: 1. Signed informed consent; 2. Sign the informed consent form for minors as appropriate according to the age of the potential subject and the standards and national standards of each research center; 3. Age >= 18 to = 16 to = 40 kg; Ulcerative colitis-specific inclusion criteria: 1. Confirmed diagnosis of UC with supportive clinical, endoscopic and histopathological evidence; 2. Extended > = 15 cm from the anal margin measured by endoscopy (soft sigmoidoscopy or colonoscopy), confirmed as active UC; 3. Subjects with only proctitis at baseline do not exceed 10% of the total enrolled number; 4. Moderately to severely active UC, defined as an mMS score of 5 - 9, including a Mayo endoscopic score (ES) of 2 or 3, confirmed by central reading of endoscopy performed at the following times: prior to the screening period (not related to the study), within 2 weeks prior to screening, and in patients with confirmed UC. If endoscopy is performed prior to screening, recordings must be available and in a format suitable for central interpretation. Previous endoscopy is only allowed for screening in accordance with the Endoscopy Procedure Manual/Bylaws Specifications. Subjects with pancolitis course > 8 years and subjects with a left-sided colitis course > 12 years Subjects who have had a surveillance colonoscopy (performed according to local standards) within 2 years prior to baseline to rule out the possibility of dysplasia Subjects who have not undergone a surveillance colonoscopy in the past 2 years must be willing to undergo a colonoscopy at screening (i.e., not a flexible sigmoidoscopy). Any adenomatous polyp must be resected as per routine practice prior to the first dose of study drug. Reproductive Inclusion Criteria: 1. For female subjects of childbearing potential: agree to remain abstinent (avoid heterosexual intercourse) or take adequate contraceptive measures during the treatment period and for 95 days after RO7790121 last dose; A female subject is considered to be of childbearing potential if she is in the late menopausal period, has not reached a postmenopausal state (amenorrhea >= 12 months in a row and has no cause other than menopause), and has not undergone surgery to permanently sterilize (i.e., removal of ovaries, fallopian tubes, and/or uterus) or has no other cause determined by the investigator (e.g., Millerian tube hypoplasia) resulting in permanent infertility. Female subjects undergoing tubal ligation are considered to be of childbearing potential according to this definition. The definition of fertile 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; hormone-releasing IUDs; Copper-containing IUDs; Male or female condoms with or without spermicide; and contraceptive caps, diaphragms or sponges containing spermicide. Male and female condoms should not be used at the same time because of the risk of contraceptive failure due to friction. The reliability of abstinence should be evaluated in the context of clinical trial duration, participant preference, and daily routine. Periodic abstinence (e.g., calendar day, ovulation, basal temperature, or pos
Exclusion criteria
Exclusion criteria: 1. Inflammatory bowel disease related exclusion criteria: (1) Severe UC, as evidenced by any of the following: 1) Hospitalization for UC within 2 weeks prior to screening= or may require hospitalization for any type of UC medical care or surgical intervention (e.g., colectomy) during the study period, in the judgment of the physician; 2) Current evidence of fulminant colitis, toxic megacolon, or recent history of toxic megacolon or intestinal perforation (within 6 months); 3) Previous extensive colectomy, subtotal colectomy, or total resection, or planned to undergo UC surgery during the study; (2) Current diagnosis of Crohn's disease (CD), abdominal/intra-abdominal/perianal fistula and/or abscess, undetermined colitis, unclassified IBD, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease; (3) Have a stoma or wear an ileoanal bag; (4) Current diagnosis or suspected primary sclerosing cholangitis; 2. Exclusion criteria related to medical history: (1) No peripheral venous access; (2) Any major surgery within 6 weeks prior to screening or planned major surgery during the study; (3) Any serious, chronic and/or unstable pre-existing medical, psychiatric or other disease that may interfere with the safety of potential subjects, obtaining informed consent, or compliance with trial procedures; (4) Pregnant or lactating, or planning to become pregnant during the study or within 95 days after the last dose of RO7790121 Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result on Day 1 before starting study treatment; (5) Any condition that may interfere with endoscopic evaluation; (6) Previous or current evidence of definite low or high colonic dysplasia or adenoma or incompletely resected tumor; (7) 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 been adequately resected and treated; (8) History of alcohol, drug, or chemical abuse within 1 year < before screening; 3. Exclusion criteria related to infection or risk of infection: (1) Any clinically significant infection or opportunistic infection requiring hospitalization, IV antibiotics, uncured within 3 months prior to randomization<; (2) Patients with Clostridium difficile (C. difficile (C. difficile; Formerly known as Clostridium difficile, it is transmitted by C. difficile toxin test assesses) evidence of infection or treatment or infection with other intestinal pathogens (assessed by stool culture and egg and parasite evaluation) or treatment within 30 days prior to randomization (Day 1); (3) Diagnosis of cytomegalovirus (CMV) colitis within the past 60 days (including the screening period); 1) Only when CMV is highly suspected clinically and whether treatment is determined, CMV needs to be confirmed by laboratory examination using a colon biopsy sample during the screening evaluation period; (2) Positive HIV test result at screening; (3) Positive hepatitis B infection test result at screening, defined as meeting any of the following criteria: 1) The test result of hepatitis B surface antigen (HbsAg) is positive at screening; 2) The quantitative HBV DNA of patients with negative hepatitis B surface antibody (HBsAb) test results and total hepatitis B core antibody (HBcAb) test results was higher than the lower limit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| pmMS from baseline to week 2;Among TL1A biomarker-defined subgroups of participants:Endoscopic improvement at Week 12;Among TL1A biomarker-defined subgroups of participants:Clinical remission at Week 12;Endoscopic remission;Bowel urgency;Endoscopic improvement;Histology Endoscopic Mucosal Improvement;Clinical response,;Histologic-endoscopic remission;Abdominal pain;IBDQ questionnaire;Fatigue; | — |
Countries
China
Contacts
Public ContactYufang Wang
West China Hospital of Sichuan University
Outcome results
None listed