A Randomized, Double-blind, Placebo-controlled Phase I/IIa Study in Patients With Abdominal or Perianal Fistulizing Crohn's Disease to Explore the Safety, Tolerability and Preliminary Efficacy of Locally Administered DLX105.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Local Tolerability
研究概览
简要总结
The primary objective of this study is to investigate the safety and tolerability of locally administered DLX105 in treating enterocutaneous fistulas in Crohn's Disease patients.
The study will consist of a screening period of approx. 2 weeks, a 4-week treatment period and a 2-week follow-up period. An end-of study visit is scheduled on Day 43, 2 weeks after the last study visit.
详细描述
Beside investigation of the safety and tolerability of locally administered DLX105, the purpose of the study is also to evaluate the response rate and time to response of enterocutaneous fistulas following local injection of DLX105 (secondary objective).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Crohn' Disease
- •Single or multiple enterocutaneous abdominal and/or perianal and/or rectovaginal fistulas of at least 3 months'duration.
- •TNF-blocker naive patients or patients who are primary or secondary anti-TNF non-responders
排除标准
- •CDAI greater than 450
- •ongoing treatment with TNF-blockers (duration of wash-out prior to randomization is 8 weeks)
- •Active abscess formation within fistula
- •Abdominal or anorectal surgery within the last 4 weeks prior to randomization
- •Known immunosuppression
- •Infections, sepsis
- •Positive Test for hepatitis B or C and HIV
- •Patients who had life vaccination within 6 weeks prior first study drug administration, or will require live vaccination during the course of the trial
- •Active liver disease with ALT and/or AST greater than 3x upper limit of normal
- •Any severe, progressive or uncontrolled medical condition that in judgment of investigator prevents the patient from participating in the study.
- •History or evidence of drug or alcohol abuse within the 6 months prior first study drug administration
- •Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive B-hCG laboratory test
研究组 & 干预措施
DLX105
DLX105 local injection into the identified fistula(s)
干预措施: DLX105 (Drug)
Placebo Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Local Tolerability
时间窗: each study visit after randomization over a period of 4 weeks
Investigator and Patient will assess the local tolerability of DLX105 for each treated fistula using a 10-cm visual analogue scale (VAS) at each study visit. Changes from Baseline will be reported descriptively.
Reduction of Number of draining fistulas
时间窗: Day 29 and Day 43 after randomization
Reduction of number of draining fistulas of 50% from baseline observed at Visit 10 and confirmed at End of Study Visit.
次要结局
- Complete Response(Day 29 and Day 43 after randomization)
- Perianal Disease Activity Index (PDAI) Score(Baseline, Day 15, Day 29, Day 43 after randomization)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerapility(each study visit over a period of 6 weeks after randomization)