Ulcerative Colitis
Conditions
Interventions
ENC1018 capsule administration group:ENC1018 capsules were taken orally once a day for 14 days.
Sponsors
Tangdu Hospital, Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years, male or female. 2. Ulcerative colitis has been diagnosed at least 3 months before screening, and the diagnosis must be confirmed by endoscopy or radiology and histology. 3. Have moderate to severe active ulcerative colitis, defined as a modified Mayo score =6. 4. Poor response or intolerance to at least one conventional therapy (aminosalicylic acids, corticosteroids, or immunomodulators) or biologics (anti-TNF, anti-a4ß7 integrin, or anti-IL-12/23 antibody drugs) as determined by the investigator. 5. If subjects are taking oral aminosalicylic acids or oral glucocorticoids, their doses must remain stable for at least 2 weeks prior to enrollment and for the duration of the study. 6. Voluntarily sign the informed consent and be willing to follow the research procedures and complete the test in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with undefined colitis, infectious colitis, ischemic colitis, fulminant colitis, toxic megacolon, or other chronic intestinal diseases other than UC such as Crohn's disease (CD), intestinal tuberculosis, radiation enteritis, and intestinal belcet's disease. 2. Never received any previous treatment for UC. 3. Participated in any other clinical trial within 3 months prior to screening (except those who have only participated in clinical trial screening without using the experimental drug). 4. Subjects with a history of alcohol or drug abuse and complete abstinence for less than 6 months before enrollment. 5. Received any live vaccine within 6 weeks prior to enrollment or planned to receive any live vaccine during the study period or within 6 weeks after the last use of the investigational drug. 6. Experienced major trauma or major surgery within 4 weeks before enrollment; 7. Have any other gastrointestinal diseases that may affect the absorption of oral drugs or have undergone gastrectomy or gastric bypass surgery. 8. Assessed by investigator as needing or receiving total parenteral nutrition and/or total enteral nutrition. 9. Allergy to the test drug or its ingredients. 10. Surgical treatment for ulcerative colitis, including but not limited to ostomy, ileal pocket anal anastomosis, and intestinal resection, is required during prior or anticipated study. 11. Previously received stem cell transplantation (except local stem cell therapy for complex anal fistulas). 12. Received organ transplants in the past and require continuous use of immunosuppressants. 13. Previous history of herpes zoster or disseminated herpes simplex. 14. Clinically significant infections (e.g., requiring hospitalization or parenteral antimicrobial therapy, or opportunistic infections) in the 6 months prior to screening were assessed by investigator to be ineligible for participation in the study. 15. Known to be infected with human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, syphilis, or other active persons: • HIV-positive individuals; • HCV antibody was positive for Anti-HCV and HCV RNA PCR was positive • Syphilis specific antibody positive; • Hepatitis B surface antigen (HBsAg) positive patients (HBSAG negative patients but HBcAb positive patients) need to undergo HBV-DNA quantitative detection. If the detection result is greater than or equal to the lower limit of normal value, they cannot be enrolled in this study; If the test result is lower than the lower limit of normal value, hepatitis B activity monitoring should be performed after enrollment). 16. Has evidence of active tuberculosis, or has previously had evidence of active tuberculosis and has not received appropriate documented treatment; Latent TB infection was defined as those who were positive for gamma interferon release tests (e.g., T cell SPOT tests for TB infection) and had not received preventive anti-TB therapy for at least 3 weeks (prior to enrolment). 17. Positive stool test results for enteric pathogens, pathogenic eggs, parasites or clostridium difficile toxins during the screening period (if negative after treatment, they can be evaluated by the researcher for re-screening or inclusion). 18. Have or have a history of malignant tumors, except for non-metastatic basal cell or squamous cell carcinoma of the skin that has been adequately treated or excised. 19. A history of any lymphoproliferative disease, such as Epstein-Barr virus (EBV) associated lymphop
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AE) and Serious Adverse Events (SAE); Changes in laboratory measurements (blood routine, blood biochemistry, coagulation function, etc.), vital signs, etc., relative to baseline;;Plasma concentrations and pharmacokinetic parameters of ENC1018 and its major metabolites in patients with moderate-to-severe active ulcerative colitis (UC). Including Tmax, Cmax, AUC0-tau, AUC0-last, AUC0-inf, t1/2, elimination rate constant (?z), etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fecal PK parameters of ENC1018 and its major metabolites: cumulative excretion amount (Ae), excretion fraction (Fe);;Changes in partial Mayo scores (excluding endoscopy scores from the complete modified Mayo score), defecation frequency (SF) scores, and blood in the stool (RB) scores from baseline;;Changes in the pharmacodynamic biomarker hsCRP and fecal calcarein from baseline; | — |
Countries
China
Contacts
Public ContactXinWang
Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed