临床试验/NCT04096573

NCT04096573撤回2 期

A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis

LG Chem0 个研究点开始时间: 2020年4月最近更新: 2021年11月15日

适应症

干预措施

试验速览

阶段: 2 期
状态: 撤回
发起方
主要终点: Clinical remission

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Aged 18 to 80 years
•Active UC confirmed by endoscopy
•Moderately to severely active UC defined as a 3-component Mayo Clinic score

排除标准

•Severe extensive colitis
•Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
•Treatment with cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil within 16 weeks of screening
•Treatment with a biologic agent (ie, anti TNFs, anti integrins, and anti interleukin 23) within 8 weeks prior to screening endoscopy
•Any prior exposure to S1P receptor modulators, natalizumab, lymphocyte-depleting therapies (ie, alemtuzumab, anti CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)

研究组 & 干预措施

LC51-0255 low dose

Experimental

Oral, daily, low dose for induction period, high dose for OLE period

干预措施: LC51-0255 (Drug)

LC51-0255 middle dose

Experimental

Oral, daily, middle dose for induction period, high dose for OLE period

干预措施: LC51-0255 (Drug)

LC51-0255 high dose

Experimental

Oral, daily, high dose for induction period, high dose for OLE period

干预措施: LC51-0255 (Drug)

placebo

Placebo Comparator

Oral, daily, placebo for induction period, high dose for OLE period

干预措施: LC51-0255 (Drug)

placebo

Placebo Comparator

Oral, daily, placebo for induction period, high dose for OLE period

干预措施: Placebo (Drug)

结局指标

主要结局

Clinical remission

时间窗: Week 12

The proportion of subjects in clinical remission assessed by Mayo component sub-scores

次要结局

Clinical response(Week 12)
Endoscopic improvement and remission(Week 12)

研究者

发起方

LG Chem

申办方类型

Industry

责任方

Sponsor

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