EUCTR2017-003090-34-BE进行中（未招募）1 期
Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 28 人开始时间: 2018年10月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each patient of Screening Cohort and Study Cohort must meet all of the following inclusion
- •criteria to be included into the trial:
- •1. 18-75 years at date of signing informed consent
- •2. Male or female patients. Women of childbearing potential (WOCBP)1 must be ready and
- •able to use highly effective methods of birth control per ICH M3 (R2) that result in a low
- •failure rate of less than 1% per year when used consistently and correctly. A list of
- •contraception methods meeting these criteria are provided in section 4.2.2.3 Restrictions
- •regarding women of childbearing potential. Restrictions regarding contraception for
- •female patients are not applicable for Screening Cohort.
- •3. Diagnosis of clinical Crohn´s Disease = 3 months prior to screening by clinical and
- •endoscopic evidence and corroborated by a histopathology report
- •4.Has = 1 perianal active* fistula(s) with clinical indication for seton drainage (= 4 weeks
- •duration before enrolment, as a complication of CD) **.
- •* Criteria for Active Fistula: As per clinical evaluation: Presence of spontaneous
- •drainage or drainage after gentle finger compression at the external openings & as
- •confirmed by radiological (MRI) exploration .
- •** Patients who are screened with a seton drainage in place are eligible provided the
- •drainage has not been in place for > 3 months and the patient meets the rest of the
- •eligibility criteria
- •5. Additional enterocutaneous or abdominal fistulas are permitted (except rectovaginal
- •6. Absent, mild or moderate clinical activity with CDAI < 250. CDAI is not applicable for
- •Screening Cohort.
- •7. Demonstrated in the past inadequate response or loss of response or have had
- •unacceptable side effects with approved doses of at least one of the following
- •compounds: Immunesuppressive agents (e.g. thiopurines, methotrexate),
- •TNF? antagonists (e.g. infliximab, adalimumab, certolizumab pegol; or respective
- •biosimilars), vedolizumab, ustekinumab, azathioprine and / or antibiotics
- •8. Patients with family history of colorectal cancer or personal history of increased
- •colorectal cancer risk must have had a negative ileocolorectal cancer screening within <1
- •year prior to screening per local guidance (otherwise to be done during screening
- •ileocolonoscopy).
- •9. Signed and dated written informed consent in accordance with ICH-GCP and local
- •legislation prior to admission to the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Complications of Crohn’s Disease such as symptomatic strictures, functional stenosis
- •distal from fistula(s), short gut syndrome, or any other manifestation that might require
- •surgery, could preclude the use of the PDAI and CDAI to assess response to therapy, or
- •would possibly confound the evaluation of benefit from treatment with BI 655130
- •2. Rectovaginal fistulas
- •3. Anticipated to require surgical intervention for CD including any fistula surgical
- •procedures (except seton drainage). See Table 4.2.2.2:1 for a detailed list of restricted
- •interventions
- •4. Has an abscess that the investigator feels requires drainage beyond fistula drainage with a
- •seton (based on either clinical assessment or MRI)
- •5. Any kind of bowel resection or diversion within 6 months or any other intraabdominal
- •surgery within 3 months prior to screening.
- •6. Ileostomy, colostomy or known fixed symptomatic stenosis of the intestine at screening.
- •7. Positive stool examinations for C. difficile or other intestinal pathogens < 30 days prior to
- •8. Evidence of colonic mucosal dysplasia or colonic adenomas, unless properly removed
- •(properly according to the investigator’s assessment)
- •9. Faecal transplant = 6 months before screening
- •Further criteria apply.
研究者
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