Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
With
Lakefront Biotherapeutics NV
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
