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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT03943550
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with UC for at least 12 weeks prior to screening
* Screening colonoscopy for colorectal cancer conducted within the prior two years if a history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis and disease duration ≥12 years
* Evidence of disease activity at time of screening
* Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC
Exclusion Criteria:
* Diagnosis of Crohn's disease or indeterminate colitis
* History of infection with hepatitis B, human immunodeficiency virus (HIV), active hepatitis C virus (HCV) infection, or other chronic infection
* Active infections requiring systemic therapy with antibiotic, antiviral or antifungal or febrile illness within 7 days before Day -1
* History of primary or acquired immunodeficiency
* Abnormal hematologic values
* Abnormal hepatic enzyme or hepatic function values
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03943550
Study Brief:
Protocol Section:
NCT03943550