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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06063967
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Participant meets the following disease activity criteria:
1. Moderate to severe CD as assessed by CDAI
2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
* Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.
Exclusion Criteria:
* Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Participants with prior exposure to p19 inhibitors.
* Participants with complications of Crohn's disease.
* Participants having an ostomy or ileoanal pouch.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06063967
Study Brief:
Protocol Section:
NCT06063967