Moderate to severe active ulcerative colitis
Conditions
Interventions
Experimental group 2 (phase II):Oral administration JMKX000189 tablet 2mg, once a day, for a total of 84 days.
Experimental group 1 (phase II):Oral administration JMKX000189 tablet 1mg, once a day, for a total of 84 days.
Control group (phase II):Oral administration placebo 0 mg, once a day, for a total of 84 days.
Experimental group (phase III):JMKX000189 tablet
Control group (phase III):Placebo
Sponsors
The First Affiliated Hospital of Sun Yat sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Those who sign an informed consent form and follow the protocol process for visits. 2. Male or female subjects aged 18-75 years (inclusive). 3. Subjects diagnosed UC at least 3 months before screening, and the diagnosis of UC was supported by clinical manifestations and endoscopic evidence, and histopathological reports (Note: if there is no previous report, endoscopic and histopathological examinations can be performed during screening). 4. Those who are moderated to severe active Ulcerative colitis is defined as a modified Mayo score (three scores include rectal bleeding, defecation frequency and endoscopic examination) of 4-9 points (inclusive), and the endoscopic single score = 2 points and rectal bleeding score = 1 point. These data were obtained from subject diary records of rectal bleeding and bowel frequency within the first 10 days of randomization, as well as colonoscopy results determined by blind center readers within the first 10 days of randomization. 5. The subject must be a UC subject undergoing treatment. If any of the following requirements are met, they can be selected and must continue to receive these treatments during the induction period: a. Before screening endoscopy, oral 5-ASA (mesalazine) drugs (such as Mesalazine, Sulfasalazine, olsalazine, balsalazide) with stable therapeutic dose have been received for at least 2 weeks. b. Before endoscopic examination in screening period, oral Corticosteroid with stable treatment dose, such as prednisone = 20 mg/day, Budesonide MMX = 9 mg/day, or Equivalent dose of steroid drug stabilizer has been treated for at least 2 weeks. 6. If subjects have recently stopped taking 5-ASA drugs or Corticosteroid to treat UC, they need to stop taking such drugs for at least 2 weeks before screening endoscopy for Mayo score. 7. Male and female subjects must agree not to participate in the pregnancy process from the beginning of screening to 30 days after the last administration (that is, actively try pregnancy or pregnancy, sperm donation, External fertilization); Female subjects with Fertility or male subjects who did not receive Vasectomy should take at least one of the following effective contraceptive methods: abstinence, surgical sterilization (such as Hysterectomy, bilateral oophorectomy), or continued use of acceptable contraceptive methods such as Intrauterine device, contraceptives, condoms, etc. during the study drug administration and = 30 days after the last drug administration.
Exclusion criteria
Exclusion criteria: 1. Clinically related cardiovascular, liver, neurological, pulmonary, ophthalmic, endocrine, psychiatric, or other major systemic diseases make protocol implementation or trial interpretation difficult, or pose risks to participants when participating in the trial. 2. The subject has undergone subtotal or total colectomy. 3. During the screening visit or in the past 3 months, there were abdominal abscesses or toxic megacolon. 4. The subject has undergone ileostomy, colonostomy, or is known to have symptoms of intestinal stenosis. 5. According to the judgment of the researchers, the subjects currently require or anticipate surgical intervention in UC during the study period. 6. The subject is suspected or diagnosed with Crohn's colitis, undiagnosed type of colitis, ischemic colitis, and radiation induced colitis. 7. Have received at least 3 biological agents related to UC treatment in the past. 8. Used traditional Chinese medicine preparations (such as herbs and traditional Chinese patent medicines and simple preparations) to treat UC or other immune diseases within 4 weeks before randomization. 9. Small molecule targeted drugs (such as upatinib) that have received treatment for UC within the first 5 elimination half-lives of randomization. 10. Within 60 days prior to randomization, have received biological agents (infliximab, adalimumab, golimumab, cetuximab, or vitellizumab), or any other experimental medication (including biological and non biological agents). 11. The subject has a history of any significant lung diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, asthma, etc; Mild intermittent asthma that does not require routine maintenance treatment is excluded. 12. The subject has a history of retinal macular edema or uveitis within the past year. 13. During the screening visit, one of the following abnormalities was found in the lung function test results (including lung ventilation function and lung exchange function test): maximum forced expiratory volume (FEV1) in 1 second or forced vital capacity (FVC)8%) judged by the researcher, or subjects with diabetes with significant complications, such as retinopathy or nephropathy. 16. Serum measurement during pregnancy, lactation, or screening ß- Human chorionic gonadotropin( ß- HCG) positive. During the screening period, any of the following laboratory test results of the subjects were abnormal: a. Hemoglobin124 µ Mol/L (female),>141 µ Mol/L (male). c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin>2 × Upper limit of normal value (ULN), or direct bilirubin>1.5 × ULN. 18. Has a history of primary or secondary immunodeficiency or is currently suffering from active primary or secondary immunodeficiency. 19. The subject has active chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; Positive for human immunodeficiency virus antibodies (HIV-Ab) or anti Treponema pallidum antibodies (TP-Ab). 20. Active malignant tumors (excluding skin or cervical basal cell carcinoma and skin in situ squamous cell carcinoma that have been removed or cured)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieved clinical remission by week 12;Percentage of subjects who achieved clinical remission in week 52; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood lymphocyte count;Mayo Index;calprotectin;C-reactive protein;Pharmacokinetics;IBDQ, SF-36, FACIT-F; | — |
Countries
China
Contacts
Public ContactBaili Chen
The First Affiliated Hospital of Sun Yat sen University
Outcome results
None listed