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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02318667
Eligibility Criteria:
Inclusion Criteria:
* Inadequate response to conventional therapy including corticosteroids or are intolerant to, or have medical contraindications for conventional therapies
* UC diagnosed prior to screening, based on a biopsy collected at endoscopy
* Moderate to severe active UC with total Mayo score of 6 to 12, inclusive at baseline, and endoscopic Mayo sub-score, greater than or equal to 2
* Adenomatous polyps removed within last 5 years or at the screening visit prior to the first drug treatment
* Extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥10 years should have a colonoscopy to exclude the presence of dysplasia within 1 year prior to study inclusion or a colonoscopy to exclude the presence of malignancy at the screening visit
* No history of untreated latent or active Tuberculosis (TB) prior to screening
* Negative stool results for enteric pathogens
Exclusion Criteria:
* History of asthma
* History of autoimmune diseases
* History of hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02318667
Study Brief:
Protocol Section:
NCT02318667