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

Trial details

Who runs it

Arena Pharmaceuticals Inc.

Trial code

EU 2024-513569-38-00

Record updated

2025. május 7.

Original description

Substudy A (SSA): •To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn’s disease (CD) Substudy 1 (SS1):•To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active CD • To select an oral etrasimod dose, based on efficacy and safety, for continued development. Please refer to protocol section 2 for more objectives.Read full original descriptionShow less

C5041006 (APD334 202 or APD334-202EU): 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

Substudy A (SSA): •To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn’s disease (CD) Substudy 1 (SS1):•To evaluate the dose-response relationship of 2 doses of etrasimod versus placebo as induction therapy in subjects with moderately to severely active CD • To select an oral etrasimod dose, based on efficacy and safety, for continued development. Please refer to protocol section 2 for more objectives.

Inclusion: Subjects 18 to 80 years of age, inclusive, at the time of consent; Ability to provide written informed consent and to be compliant with the schedules of protocol assessments; Have CD for ≥ 3 months prior to randomization, involving the ileum and/or colon, at a minimum; diagnosis may be confirmed at any time in the past by endoscopy and histopathology. The screening endoscopy and histopathology reports may serve as source documents for subjects who do not have diagnostic endoscopy reports in their medical chart; Have moderately to severely active CD at Screening, defined as: Crohn’s Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, AND  Unweighted average worst daily abdominal pain (AP) score ≥ 2 (using a 4-point scale; ie, 0 [none] to 3 [severe]) OR unweighted average daily loose/watery stool frequency (SF) (Bristol Stool Form Scale [BSFS] type 6 or 7) score ≥ 4, AND Simple Endoscopic Score in Crohn’s disease (SES-CD) of ≥ 6 or SES-CD ≥ 4 for subjects with isolated ileal disease; Demonstrated inadequate response, loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD (refer to Appendix 9, refer to Appendix 11 for Israel specific criteria): - Oral corticosteroids (eg, prednisone [or its equivalent] or budesonide) - Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate) - Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars) - Integrin receptor antagonist (eg, vedolizumab) - Interleukin-12/-23 antagonist (eg, ustekinumab); Females of childbearing potential must be nonpregnant; Females of childbearing potential and males must agree to use contraception (refer to Section 4, Inclusion Criterion 7 for SSA-P2, SS1-P2b, or SS2-I; Inclusion Criterion 6 for SS3-M; and Inclusion Criterion 4 for SS4-E).

Exclusion: 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. Subjects who have undergone previous colonic resection or ileocolectomy must have > 25 cm of colon remaining; Have a serious infection requiring intravenous antibiotic(s)/medication(s) ≤ 4 weeks prior to randomization; 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, refer to Appendix 9); 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; 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; Have an ileostomy or a colostomy; Lactating female who is breastfeeding.

EU CTIS 2024-513569-38-00