Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ability to provide a written informed consent
Females of childbearing potential must have a negative pregnancy test at screening and baseline
Documented diagnosis of Crohn's disease with a minimum disease duration of 6 months with involvement of the ileum and/or colon at a minimum
Moderately to severely active Crohn's disease as defined by a Crohn's Disease Activity Index (CDAI) total score between 220-450 (inclusive) AND with evidence of active disease as measured by ileocolonoscopy
Within the previous 5 years, demonstrated an inadequate clinical response or intolerance of at least one of the following agents:
* Corticosteroids
* Immunomodulators
* Tumor necrosis factor-alpha (TNFα) antagonists
* Vedolizumab
May be receiving the following drugs:
* Oral 5-aminosalicylate (5-ASA)
* Oral corticosteroid therapy
* Antidiarrheals for chronic diarrhea
* Azathioprine or 6-mercaptopurine (6-MP) or methotrexate
* Antibiotics for the treatment of Crohn's disease
Able to comply with the dosing instructions for study drug and able to comply with the study visits and requirements
You may not be if
Evidence of abscess at screening
Extensive colonic resection (subtotal or total colectomy) or history of \> 2 small bowel resections
Ileostomy, colostomy, or symptomatic stenosis of the intestine
Current use of oral corticosteroids at a dose equivalent to \> 30 mg/day of prednisone
Ulcerative colitis or indeterminate colitis
Short bowel syndrome
Stool sample positive for Clostridium difficile (C. difficile) toxin, E. coli, Salmonella, Shigella, Campylobacter or Yersinia
Treatment with any monoclonal antibody within 4 weeks of screening
History or evidence of colonic mucosal dysplasia
HIV, hepatitis B, hepatitis C, or tuberculosis (TB) infection
Participated in a clinical study with an investigational drug or biologic within the last 30 days
Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) that, in the opinion of the investigator, would make the individual unsuitable for the study or would prevent compliance with the study protocol
