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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07310095
Eligibility Criteria:
Inclusion Criteria:
* Has a confirmed diagnosis of Crohn's disease (CD)
* Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 and either mean daily stool frequency (SF) count \>= 4 or mean daily abdominal pain (AP) score \>=2
* Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \[mg\]/kilogram \[kg\] intravenous \[IV\] followed by 90 mg subcutaneous \[SC\] at week 8) as the instruction manual
* Initially responded to UST induction therapy and then lose response to UST
* During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
Exclusion Criteria:
* Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)
* Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
* Is currently enrolled in an interventional clinical study
* Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
* Have a current or be suspected to have an abscess
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07310095
Study Brief:
Protocol Section:
NCT07310095