EUCTR2017-003090-34-DE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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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. Diagnosis of clinical Crohn´s Disease = 3 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report
- •3. 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 fistulas)
- •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
- •No exclusion criteria are applicable for the Screening Cohort.
- •Following exclusion criteria are applicable for the Study Cohort:
- •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. Evidence of colonic mucosal dysplasia or colonic adenomas, unless properly removed
- •(properly according to the investigator’s assessment)
- •8. Faecal Microbiota transplant (FMT) within 6 months prior to randomization
- •Further criteria apply.
研究者
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