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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT02435992
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 75 years (at screening for Cohort 1 and 2)
* UC confirmed on endoscopy
* Moderately to severely active UC (May score 6-12)
* Currently receiving treatment with aminosalisylate, prednisone, or budesonide
* Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization
Exclusion Criteria:
* Have severe extensive colitis as evidence by:
* Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
* Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
* Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
* History of uveitis or unknown macular edema
* Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02435992
Study Brief:
Protocol Section:
NCT02435992