A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assessthe Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohnâ??s Disease

Arena Pharmaceuticals0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Subjects 18 to 80 years of age, inclusive, at the time of consent
•2. Ability to provide written informed consent and to be compliant with the schedules of protocol assessments
•3. Diagnosed with Crohnâ??s Disease >= 3 months
•4. Have moderately to severely active CD at Screening
•5. Demonstrated inadequate response, loss of response to, or intolerance to >= 1 of the following therapies for the treatment of CD
•â?? Oral corticosteroids (eg, prednisone [or its equivalent] or budesonide)
•â?? Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate)
•â?? Tumor necrosis factor alpha (TNFÎ±) antagonists (eg, infliximab, adalimumab,
•certolizumab pegol, or biosimilars)
•â?? Integrin receptor antagonist (eg, vedolizumab)
•â?? Interleukin-12/-23 antagonist (eg, ustekinumab)
•6. Females of childbearing potential must be nonpregnant
•7. Females of childbearing potential and males must agree to use contraception
•Participants who entered the Extended Induction Period of SS1, SS2 must have completed the Extended Induction â?? Week 6 Visit (Inclusion for SS3)
•Participant must have completed the Week 52 Visit of SS3 or the Week 66 Visit of SSA (Inclusion for SS4)

•. History of inadequate response (ie, primary non-response) to agents from >= 2 classes of biologics marketed for the treatment of CD (ie, TNFÎ± antagonists, interleukin-12/-23 antagonist, and integrin receptor antagonist)
•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 <= 8 weeks prior to randomization or surgical treatment for perianal abscesses <= 4 weeks prior to randomization
•5. Had intestinal resection <= 24 weeks prior to randomization or other intra-abdominal surgeries <= 12 weeks prior to randomization. Subjects who have undergone previous colonic resection or ileocolectomy must have > 25 cm of colon remaining
•6. Have an ileostomy or a colostomy

发起方

Arena Pharmaceuticals