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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02765256
Eligibility Criteria:
Inclusion Criteria:
* Participant is capable of giving informed consent
* Males or females 18-75 years of age
* Normal kidney function (defined by normal serum creatinine \[male: \<1.27 mg/dL; female: \<1.03 mg/dL\])
* Normal aspartate aminotransferase \[AST\] (\<41 U/L), alanine aminotransferase \[ALT\] (\<63 U/L), and alkaline phosphatase (\<126 U/L)
* Active CD defined as HBI ≥ 7
* CRP \> 5 mg/dL or hs-CRP \> 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) \> - - 350 mcg/g (within one month of enrollment)
* Have been treated with one of the following therapies\*\* for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response \[LOR\] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab \*\*These medications must have been administered at standard, therapeutic dosages.
Exclusion Criteria:
* Known or suspected stricturing disease producing obstructive symptoms
* Active Clostridium difficile infection
* Unwillingness to provide informed consent
* Allergy or intolerance to the medications used in this study
* History of kidney disease
* History of liver disease
* Pregnant or lactating females
* Baseline QTc interval on EKG \> 430 in males or \> 450 in females
* Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02765256
Study Brief:
Protocol Section:
NCT02765256