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
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
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
Oral, daily, low dose for induction period, high dose for OLE period
干预措施: LC51-0255 (Drug)
LC51-0255 middle dose
Oral, daily, middle dose for induction period, high dose for OLE period
干预措施: LC51-0255 (Drug)
LC51-0255 high dose
Oral, daily, high dose for induction period, high dose for OLE period
干预措施: LC51-0255 (Drug)
placebo
Oral, daily, placebo for induction period, high dose for OLE period
干预措施: LC51-0255 (Drug)
placebo
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)