CULTIVATEA 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

Fecha de inicio: 6 de enero de 2020

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