None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : The preparation of ustekinumab intravenous and the administration method for both ustekinumab intravenous and subcutaneous will be conducted according to the appr
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 to under 75 years 2) Patients diagnosed with moderate-to-severe (Mayo score 6-12) ulcerative colitis and undergoing treatment 3) Patients who do not respond to or are intolerant to corticosteroids, immunosuppressants, biologic agents (TNF-a inhibitors or integrin inhibitors), or small molecules (JAK inhibitors or S1P receptor modulators) 4) Patients with Fecal calprotectin = 250 µg/g or CRP = 0.5 mg/dL 5) Patients with a Mayo Endoscopic Score of 2 or higher 6) Patients who have voluntarily provided written informed consent for participation in the clinical trial
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity to humanized proteins 2) Patients who have previously received biologic agents targeting IL-12 and/or IL-23 3) Patients who have had intra-peritoneal surgery within the last 6 months or are expected to undergo ulcerative colitis-related bowel surgery during the trial period. 4) Patients with active tuberculosis - However, patients with a past history of tuberculosis who have completed tuberculosis treatment according to standard guidelines and have been declared cured are eligible 5) Patients with latent tuberculosis - However, patients with latent tuberculosis who have completed 3 weeks of treatment or who will complete treatment for latent tuberculosis in the future are eligible. 6) Patients with hepatitis B or C 7) Patients with a history of HIV infection or who test positive for HIV antibodies at the screening visit 8) Patients with NYHA Class III/IV heart disease 9) Pregnant or breastfeeding women 10) Patients with severe infections, or with a history of malignant tumors (except for basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma)within 5 years prior to screening or a history of dysplasia in the colon or small intestine within 5 years prior to screening 11) Women of childbearing potential who are not using appropriate contraception or do not plan to use appropriate contraception during the trial and for at least 6 months after the last dose of ustekinumab (acceptable methods of contraception include oral, injectable, or implantable hormonal contraceptives, diaphragms, condoms, intrauterine devices) 12) Patients with severe complications at the screening visit: - Toxic megacolon, intra-abdominal abscess, small inestinal or colon stenosis, Clostridium difficile infection, or cytomegalovirus-related colitis 13) Patients who have received live vaccines within 30 days prior to screening 14) Patients deemed by principal investigator to be unsuitable for participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate;Endoscopic remission rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Endoscopic remission and response rates;Clinical response rate;Biochemical marker results;Ulcerative colitis endoscopic score;Comparison of histological scores from the Nancy Index (NI);Corticosteroid-free endoscopic remission rate;Corticosteroid-free clinical response rate;Corticosteroid-free clinical remission rate;Ustekinumab serum concentration and antibody production;Safety assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Hee Cheon
Yonsei University Health System, Severance Hospital
Outcome results
None listed