A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Participants With Moderately to Severely Active Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 105
- 主要终点
- Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
研究概览
简要总结
This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease.
详细描述
This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease. Approximately 93 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD (yes/no).
The study consists of a 30-day Screening Period, a 12-week double-blind Induction Treatment Period, a 40-week double-blind Maintenance Treatment Period, an Open-Label Extension (OLE) of up to 144 weeks, and a 30-day safety Follow-Up Period. The maximum duration of treatment will be 36 months, including the Induction, Maintenance, and OLE Periods. For all participants, a Follow-Up visit will be performed at 30 days after the last dose of study drug.
Objectives Primary Objectives
* Evaluate the efficacy of VTX958 in achieving reduction in Crohn's Disease Activity Index (CDAI) score at the end of the Induction Period
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. Participants, Investigators, study center staff, persons performing the assessments, and the Sponsor are to remain blinded to the identity of the Induction and Maintenance 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, 18 to 75 years of age, inclusive, at the time of consent
- •Capable of giving signed informed consent
- •Documented diagnosis of CD ≥ 3 months prior to Day
- •The diagnosis of CD must be confirmed by clinical, endoscopic, and histologic evidence.
- •Moderately to severely active CD
排除标准
- •Current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
- •Presence of a stoma or ileoanal pouch
- •Presence of currently known complications of CD such as symptomatic bowel stricture(s) and >2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, left and sigmoid colon, and rectum, fulminant colitis, toxic megacolon or any other manifestation that may require surgery or hospitalization
- •Known diagnosis of short gut or bowel syndrome
- •Previous exposure to VTX958 or any other TYK2 inhibitor (eg, deucravacitinib) in any study
研究组 & 干预措施
VTX958 Dose A
干预措施: VTX958 (Drug)
VTX958 Dose B
干预措施: VTX958 (Drug)
VTX958 Placebo
干预措施: VTX958 Placebo (Drug)
结局指标
主要结局
Change in mean Crohn's disease Activity Index (CDAI) score from baseline to week 12
时间窗: During screening to week 12
Change in Mean CDAI (Crohn's disease Activity Index). CDAI is a weighted index comprising eight Crohn's Disease (CD)-related clinical and laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, and general well-being, are patient-reported measures recorded daily. The total CDAI score is calculated using the sum of each variable times the multiplier. The total score range of the CDAI is from 0 to 600.
次要结局
- The proportion of participants achieving endoscopic response at Week 12(During screening to week 12)
- Proportion of participants achieving clinical remission at Week 12(During screening to week 12)
- Change from baseline in mean simple endoscopic score in Crohn's disease SES-CD at Week 12(During screening to week 12)
- Proportion of participants achieving clinical response at Week 12(During screening to week 12)
- Proportion of participants achieving both endoscopic response (outcome- measure # 2) and clinical remission (outcome measure # 4) at Week 12(During screening to week 12)
- Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12(During screening to week 12)