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 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT03046056
Eligibility Criteria:
Key Inclusion Criteria:
* Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
* Moderately or severely active CD
* Minimum duration of CD of at least 6 months
* Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
* Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
* Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
* Corticosteroids
* Immunomodulators
* Tumor necrosis factor-alpha (TNFα) antagonists
* Vedolizumab
* Ustekinumab
* Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements
Key Exclusion Criteria:
* Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
* Presence of fistulae
* Evidence of short bowel syndrome
* Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
* History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
* Use of any prohibited concomitant medications as described in the study protocol
* Active tuberculosis (TB) or history of latent TB that has not been treated
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03046056
Study Brief:
Protocol Section:
NCT03046056