A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 213
- 试验地点
- 77
- 主要终点
- Clinical Remission at 13 Weeks
研究概览
简要总结
This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily.
The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VTX002 in subjects with moderately to severely active UC following daily oral administration of VTX002 as a tablet. Approximately 189 eligible subjects will be randomized in a 1:1:1 ratio to receive VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily (approximately 63 subjects per treatment group).
The study consists of a 28-day Screening Period, a 13-week double-blind Induction Treatment Period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.
Objectives Primary Objective
• Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission
Secondary Objectives
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will employ a double-blind design. Subjects, Investigators, study center staff, persons performing the assessments, central endoscopy readers and the Sponsor are to remain blinded to the identity of the Induction Period treatment from the time of randomization until the interim database lock for the study.
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
- •Diagnosed with UC ≥ 3 months prior to Screening.
- •Active UC confirmed by endoscopy
排除标准
- •Severe extensive colitis
- •Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
- •Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
研究组 & 干预措施
VTX002 Dose A
VTX002 Dose A tablet administered orally once daily
干预措施: VTX002 (Drug)
VTX002 Dose B
VTX002 Dose B tablet administered orally once daily
干预措施: VTX002 (Drug)
Placebo
Placebo tablet administered orally once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Remission at 13 Weeks
时间窗: Day 1 of Induction treatment period to Week 13
The percentage of participants with clinical remission at Week 13. Clinical remission was based on the modified Mayo score (MMS), which is a composite score of participant-reported symptoms and endoscopies which were assessed by a central reader. Clinical remission was defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
次要结局
- Endoscopic Improvement at Week 13(Day 1 of Induction Treatment Period to Week 13)
- Symptomatic Remission at Week 13(Day 1 of Induction Treatment Period to Week 13)
- Histologic Remission at Week 13(Day 1 of Induction Treatment Period to Week 13)
- Endoscopic Improvement-Histologic Remission at Week 13(Day 1 of Induction Treatment Period to Week 13)
- PK of VTX002(Weeks 1, 4, 8, and 13 of the Induction Treatment Period)