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, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
Has draining perianal fistulae as a complication of CD, confirmed by magnetic resonance imaging (MRI) at screening
Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
* Antibiotics AND/OR
* Immunomodulators AND/OR
* Tumor necrosis factor α (TNFα) Antagonist
Is willing and able to undergo MRI per protocol requirements
Is willing and able to undergo flexible sigmoidoscopy per protocol requirements
You may not be if
Presence of current rectovaginal anovaginal or enterovesicular fistulae
Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
History of total proctocolectomy, total 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
