None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : This is a prospective, randomized, open label, multi-center, phase IV study in Korean adult patients with moderately to severely active UC. UC patients who are cu
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 19 to 80 years at the time of enrolment. 2. UC patients who are currently being treated with vedolizumab IV Q8W for more than 24 weeks but has lost response* and plan to have dose escalation to Q4W *The loss of response will be defined as recurrence or worsening of IBD-related symptoms (total Mayo score >6 with an endoscopic subscore =2) that may require surgery, change in medicinal treatment, or vedolizumab dose intensification to Q4W. 3. Disease extent: Left sided colitis or pan-colitis patients 4. Biologic naïve patients or patients who failed to 40 IU/L or at least 5 years since last regular menses, confirmed before any study medication is implemented). *** The acceptable method of contraception includes condoms, oral contraceptives, intrauterine devices, tubal ligation, and sterilization when using injectable or implantable contraceptives. 7. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 8. The participant or, when applicable, the participant’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
Exclusion criteria
Exclusion criteria: 1. Participant who has hypersensitivity to vedolizumab or any of the excipients. 2. Participant who has received any live vaccinations within 30 days prior to vedolizumab administration. 3. Participant who had previous exposure to approved or investigational anti-integrins (e.g., natalizumab, efalizumab, etrolizumab, abrilumab) or anti-MAdCAM-1 antibodies or rituximab. 4. Participant who are planning to receive corticosteroids or are currently receiving corticosteroids. 5. Participant who has a history of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to Screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participant with remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case by-case basis prior to Screening. 6. Participant who has history or presence of colonic dysplasia or cancer. 7. Participant who has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or demyelinating neurodegenerative disease. 8. Participant has any of the following laboratory abnormalities during the screening period: i. Hemoglobin level 1200 x 109/L v. ALT or AST > 3 x ULN vi. Alkaline phosphatase > 3 x ULN vii. Serum creatinine > 2 x ULN. 9. Participant who has current active TB infection, TB infection history without documentation of cure after standard anti-TB treatment, or latent TB infection without treatment or with less than 3 weeks treatment before enrolment (refer to section 7.1.6). 10. Participant who has infections such as sepsis, CMV, listeriosis, and opportunistic infections such as PML. 11. Participant who has chronic HBV infection* or chronic HCV infection. *HBV immune participants (i.e., being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive) may, however, be included. 12. Participant has any identified congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, HIV infection, organ transplantation). 13. Participant who has condition which in the opinion of the investigator may interfere with the participant’s ability to comply with the study procedures. 14. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period. 15. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter. 16. Participant who does not agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the change of T cell imbalance in association with the recapture of clinical response after dose escalation of vedolizumab administered IV or SC at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the clinical and endoscopic response and remission of vedolizumab SC Q2W versus vedolizumab IV Q4W after loss of response to vedolizumab IV Q8W ;To evaluate the differential changes of drug level, gene expression, and immune cell phenotype signatures with vedolizumab IV and SC after loss of response to vedolizumab IV Q8W | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hee Cheon
Yonsei University Health System, Severance Hospital
Outcome results
None listed