Last updated on July 2020

A Study Evaluating the Efficacy and Safety of Etrasimod in the Treatment of Patients With Moderately to Severely Active Crohn's Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease (Pediatric) | Crohn's Disease | Inflammatory bowel disease
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Men or women 18 to 80 years of age,
  • Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
  • Diagnosed with Crohn's disease (CD) 3 months
  • Have moderately to severely active CD at Screening
  • Demonstrated inadequate response, loss of response to, or intolerance to 1 of the following therapies for the treatment of CD:
    1. Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
    2. Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6 MP], or methotrexate [MTX])
    3. Tumor necrosis factor alpha (TNF) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
    4. Integrin receptor antagonist (eg, vedolizumab)
    5. Interleukin 12/ 23 antagonist (eg, ustekinumab)
  • Females of childbearing potential must be nonpregnant
  • Females of childbearing potential and males must use contraception

Exclusion Criteria:

  • History of inadequate response (ie, primary non response) to agents from 2 classes of biologics marketed for the treatment of CD (ie, TNF antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
  • Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridium difficile toxin at Screening.
  • Have functional or post operative short bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
  • Had surgical treatment for intra abdominal abscesses 8 weeks prior to randomization or surgical treatment for perianal abscesses 4 weeks prior to randomization.
  • Had intestinal resection 24 weeks prior to randomization or other intra abdominal surgeries 12 weeks prior to randomization.
  • Have an ileostomy or a colostomy.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.