Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
NCT ID:
NCT06897150
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with UC based on endoscopic and histological findings
* Patients with clinically and endoscopically moderate UC who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate UC were also considered eligible as an exception)
* Patients who exhibited an inadequate response to or intolerance of 5-ASA formulations (including topical agents) or budesonide formulations (including topical agents)
* Patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period
* Patients who agreed to blood sampling and fecal biomarker tests
Exclusion Criteria:
* Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
* Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
* Patients with a history of malignancy
* Patients with severe hepatic dysfunction
* Pregnant women or those planning pregnancy
* Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06897150
Study Brief:
Protocol Section:
NCT06897150