临床试验/2024-513569-38-00

2024-513569-38-00

已完成

2/3 期

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

Arena Pharmaceuticals Inc.74 个研究点分布在 11 个国家目标入组 367 人开始时间: 2024年9月3日最近更新: 2025年5月7日

概览

阶段: 2/3 期
状态: 已完成
发起方: Arena Pharmaceuticals Inc.
入组人数: 367
试验地点: 74
主要终点: SSA-P2:Proportion of subjects with endoscopic response

概览入排标准结局指标研究者研究点记录与标识符相似试验

概览

简要总结

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.

入排标准

年龄范围: 18 years 至 65+ years（18-64 Years, 65+ Years）
接受健康志愿者: 是

入选标准

•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)

排除标准

•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
•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 an ileostomy or a colostomy
•Have a serious infection requiring intravenous antibiotic(s)/medication(s) ≤ 4 weeks prior to randomization
•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
•Lactating female who is breastfeeding

结局指标

主要结局

SSA-P2:Proportion of subjects with endoscopic response

SS1-P2b:Proportion of subjects with endoscopic response at Week 14

SS2-I: • Proportion of subjects with endoscopic response at Week 14. • Proportion of subjects with clinical remission CDAI at Week 14

SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 • Proportion of subjects with endoscopic response at Week 52

次要结局

SSA-P2:• Proportion of subjects with clinical remission CDAI • Change from baseline in SES-CD score • Change from baseline in CDAI score. •Etrasimod plasma concentrations at 4 hours postdose and at steady-state trough concentrations at selected timepoints.• Change and percentage change from baseline in ALC.
SS1-P2b:• Proportion of subjects with clinical remission CDAI at Week 14 • Proportion of subjects with clinical remission by PRO2 at Week 14
SS2-I:• Proportion of subjects with clinical remission PRO2 at Week 14 • Proportion of subjects with clinical response CDAI at Week 14 • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14 • Proportion of subjects with endoscopic remission at Week 14 •
SS3-M: • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M baseline
SS4-E:• Proportion of subjects with clinical remission CDAI by visit up to the end of treatment • Proportion of subjects with clinical remission PRO2 by visit up to the end of treatment

研究者

发起方

Arena Pharmaceuticals Inc.

申办方类型

Pharmaceutical company

责任方

Principal Investigator

主要研究者

Clinical Medical Lead

Scientific

Arena Pharmaceuticals Inc.

研究点 (74)

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