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
- Other
- 发起方
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- 1. Change in mean Crohns 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 (placebo, 225 mg BID, and 300 mg BID) in participants with moderately to severely active CD. Approximately 132 eligible patients will be randomized, and randomization will be stratified by prior use of biologics for the treatment of CD (yes/no).
The target patient population will include:
• Patients who have had an inadequate response, loss of response, or intolerance toconventional therapy and are naïve to biologic agents (conventional treatment failed)
• Patients who have had an inadequate response, loss of response, or intolerance to abiologic agent (biologic failed). Patients in this category may have received priorconventional therapy. It is expected that approximately 70% of participants in the studymay have had an inadequate response to biologics. The number of patients with priorexposure to biologic therapy targeting IL-12/IL-23 (eg, ustekinumab) to be randomizedinto this study will be capped at 20% of the total number of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
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.
结局指标
主要结局
1. Change in mean Crohns disease Activity Index (CDAI) score from baseline to week 12
时间窗: During screening to week 12
2. The proportion of participants achieving endoscopic response at Week 12
时间窗: During screening to week 12
次要结局
- Change from baseline in mean simple endoscopic score in Crohns disease SES-CD at Week 12(- Change from baseline in mean simple endoscopic score in Crohns disease SED-CD at 12 weeks. The SES-CD is an endoscopic grading system is used to assess CD disease activity. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, & presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.)
- Proportion of participants achieving clinical remission at Week 12(- Clinical remission is defined as a CDAI score 150. CDAI is a weighted index comprising eight Crohns Disease (CD)-related clinical & 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.)
- Proportion of participants achieving both endoscopic response (outcome- measure # 2) & clinical remission (outcome measure # 4) at Week 12(- Proportion of participants achieving both endoscopic response (as described in outcome measure 2) and clinical remission (as described in outcome measure 4) at Week 12.)
- Proportion of participants achieving patient-reported outcome 2 (PRO2) remission at Week 12(- The proportion of participants achieving PRO2 remission at week 12. PRO2 remission is defined is an unweighted CDAI component of daily AP score ≤ 1 & unweighted CDAI component of daily average stool frequency (SF) score ≤ 3)
- Proportion of participants achieving clinical response at Week 12(- Proportion of participants achieving clinical response at Week 12. A clinical response is defined as ≥ 100 points reduction from baseline in CDAI score or CDAI score 150. CDAI is a weighted index comprising eight Crohns Disease (CD)-related clinical & laboratory variables, to assess CD disease activity. Three of the variables, stool frequency, abdominal pain, & 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.)