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

For people ages 18-80

Eligibility criteria applicable to all substudies:

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 (ie, primary non-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 (TNFα) 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, TNFα 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 Clostridioides 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.

Inclusion Criteria for Substudy 3:

• Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit

Inclusion Criteria for Substudy 4:

• Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A