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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT05013905
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of Crohn's disease
* Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy
* Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23
* Able to provide written informed consent and understand and comply with the requirements of the study
Exclusion Criteria:
* Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug
* Diagnosis of ulcerative colitis (UC) or indeterminate colitis
* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement
* Suspected or diagnosed intra-abdominal or perianal abscess at screening
* Current stoma or need for colostomy or ileostomy
* Previous small bowel resection with a combined resected length of \>100 cm or previous colonic resection of \> 2 segments
* Surgical bowel resection within 3 months before screening
* Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed
* Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study
* Subjects who meet the protocol criteria for important laboratory exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05013905
Study Brief:
Protocol Section:
NCT05013905