Ulcerative Colitis
Conditions
Interventions
test group:Take a 25 mg dose of H021 tablets orally once a day within 30 minutes of breakfast, consecutively.
Sponsors
Gansu province people hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects' age is >= 18 years old and gender is not limited; 2.Subjects have evidence of moderately to severely active ulcerative colitis. Defined as an endoscopically and histologically confirmed diagnosis of ulcerative colitis, who also meets a Modified Mayo Score (MMS) of 5 to 9 and an endoscopic score >= 2 prior to the first dose. Accept endoscopy and histology results from our institution within 2 weeks prior to the first dose; 3.Subjects who are receiving oral 5-aminosalicylic acid (5-ASA) or glucocorticoid combination therapy will be required to remain on a stable dose of medication for the first 2 weeks of endoscopy within the screening period and throughout the study period; 4. Subjects who are being treated with azathioprine, 6-mercaptopurine, or methotrexate are required to remain on a stable dose of the medication for 4 weeks prior to (i.e., baseline) the screening intra-period microscopy and throughout the study period; 5. Subjects are required to fully understand the content of the trial, participate in the trial voluntarily, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects with ulcerative colitis limited to isolated proctitis; 2.Subjects with primary sclerosing cholangitis or autoimmune hepatitis; 3.Subjects with Crohn's disease, or current or past history of fistula, unclassified colitis, infectious/ischemic colitis, or microscopic colitis (lymphocytic or collagenous colitis); 4.Subjects with a past or current history of toxic megacolon, fulminant colitis, or bowel perforation; 5.Subjects with a history of colon cancer, previous or current presence of mild or severe colonic alloplastic hyperplasia and/or adenomatous polyps that have not been completely removed; 6.Subjects who have undergone bowel surgery within 4 weeks prior to the first dose; or are scheduled to undergo bowel surgery within 12 weeks of study entry; or have a current stoma; or have undergone previous rectal/colonic resection or partial rectal/colonic resection; 7.Subjects with chronic or recurrent grade 3/4 infection within 2 months prior to screening; or a history of opportunistic infections while on immunosuppressive therapy; 8.Subjects with reactivation of herpes zoster within 2 months prior to screening; 9.Subjects with severe and known active infections at the time of screening, such as infectious abscesses, Clostridium difficile, cytomegalovirus, Epstein Barr virus (EBV), etc. (subjects who are positive for C. difficile may be treated and retested >2 weeks after completion of treatment, and those who retest negative are eligible to participate in this study); or subjects with any episode of severe infection requiring hospitalization or intravenous antibiotic therapy within 1 month prior to or during screening. Fungal infections of the nail bed are acceptable; 10.Subjects with congenital or acquired immunodeficiency (positive test result for human immunodeficiency virus antibody HIV-Ab) at screening; 11. Subjects with acute or chronic hepatitis B virus (HBV) infection at the time of screening (i.e., hepatitis B surface antigen [HbsAg] positive, or anti-hepatitis B core antibody [anti-HBc] positive with detectable hepatitis B virus deoxyribonucleic acid [HBV DNA]); subjects with acute or chronic hepatitis C virus (HCV) infection at the time of screening (i.e. subjects who are hepatitis C virus antibody positive, relapse free >1 year after successful treatment and have undetectable hepatitis C virus ribonucleic acid [HCV RNA] are eligible for this study); 12.Subjects with active tuberculosis (TB) or untreated latent TB at screening; 13.Subjects with a positive test result for syphilis spirochete-specific antibodies at screening; 14.Subjects with a history of malignant tumor or active malignant tumor (except for subjects with progression-free survival of more than 5 years); 15.Subjects with clinically significant laboratory test abnormalities at screening and judged by the investigator to be unfit to participate in this study; 16.Subjects who have received live vaccine within 3 months prior to screening; or who plan to receive live vaccine during the study period; 17.Subjects who do not meet the requirements described in the [Prohibited Prior Medications and Combinations of Medications] section for the elution period of the prohibited medications in the study protocol prior to microscopy during the screening period; 18.Subjects who have received a fecal flora transplant (FMT) within 6 months prior to Screening FMT is defined as receiving any product der
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic indicators;Efficacy indicators; | — |
Countries
China
Contacts
Public ContactPing Mai
Gansu province people hospital
Outcome results
None listed