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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT03800420
Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated informed consent form (ICF)
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged \>=18 years
* Diagnosed with active UC for at least 3 months prior to screening
* Total Mayo score \>=5 and Endoscopic sub-score \>=1
* Stable dosing regimens of oral drugs (if currently administered) as follows: 5-ASA or sulfasalazine at a stable dose for at least 4 weeks, purine analogues (azathioprine, mercaptopurine, thiopurines) or methotrexate at a stable dose for at least 12 weeks, and low-dose oral corticosteroid (up to 20 mg prednisone/day or equivalent) for at least 4 weeks prior to the first dose of study treatment. Doses of oral drugs must remain stable until the end of study treatment (with possible exception for tapering steroid dose after 8 weeks)
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 3 months after the last dose
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 3 months after the last dose
Exclusion Criteria:
* Use of anti-TNF-a biologics or any other biologics for treatment of UC within 60 days prior to randomization.
* Any rectal therapy for treatment of UC or intravenous corticosteroids within 2 weeks prior to randomization.
* Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
* Previous extensive colonic resection (subtotal or total colectomy)
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
* Evidence of or treatment for Clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to randomization
* Active infection with the HIV or Hepatitis B or C viruses
* Clinically significant active extra-intestinal infection (e.g., pneumonia, pyelonephritis)
* Clinically significant abnormal vital signs, physical examination or 12-lead electrocardiogram (ECG) at screening or baseline
* Clinically significant abnormal results of liver function tests (ALT/AST, bilirubin and alkaline phosphatase) \> 2X the upper limit of normal (ULN) at screening
* Other clinically significant abnormal laboratory results at screening in the investigator's opinion
* History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
* Pregnancy or lactation
* Treatment with another investigational drug or other intervention within 30 days prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03800420
Study Brief:
Protocol Section:
NCT03800420