A Multicenter Randomized Double-Blind Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for 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
  • Age: Between 18 Year(s) - 150 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Able to provide written informed consent
    2. Have Crohn’s disease (CD)for greater than or 3 months prior to randomization
    3. Have moderately to severely active CD at Screening
    4. Demonstrated inadequate response, loss of response to, or intolerance to more than 1 of the following therapies for the treatment of CD
      • Oral corticosteroids
      • Immunosuppressants
      • Tumor necrosis factor alpha (TNFa) antagonists
      • Integrin receptor antagonist
      • Interleukin-12/-23 antagonist
    5. Females of childbearing potential must be nonpregnant
    6. Females of childbearing potential and males must agree to use contraception

You may not be eligible for this study if the following are true:

    1. History of inadequate response (ie, primary non-response) to agents from more than 2 classes of biologics marketed for the treatment of CD
    2. 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 Clostridioides difficile toxin at Screening
    3. Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
    4. Had surgical treatment for intra-abdominal abscesses less than or equal to 8 weeks prior to randomization or surgical treatment for perianal abscesses less than or equal to 4 weeks prior to randomization
    5. Had intestinal resection less than or equal to 24 weeks prior to randomization or other intra-abdominal surgeries less than or equal to 12 weeks prior to randomization. Subjects who have undergone previous colonic resection or ileocolectomy must have greater than or equal to 25 cm of colon remaining
    6. Have an ileostomy or a colostomy
    7. Have a serious infection requiring intravenous antibiotic(s)/medication(s) = 4 weeks prior to randomization
    8. Have primary or secondary immunodeficiency syndromes, history of organ transplant, history of an opportunistic infection, history of disseminated herpes simplex or herpes zoster, have or test positive for human immunodeficiency virus, hepatitis B virus, or active hepatitis C virus
    9. Lactating female who is breastfeeding

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