Fistulizing Crohn’s Disease MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 = 4 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 fistulas) 6. Absent, mild or moderate clinical activity with CDAI =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 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 screening 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. 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 screening 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To explore the pathomechanisms involved in the generation and healing of CD associated perianal fistulas - To understand the MoA of BI 655130 in patients with CD and draining perianal fistulas;Secondary Objective: -;Primary end point(s): 1) Total number of deregulated genes at week 4;Timepoint(s) of evaluation of this end point: 1) week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Proportion of patients with perianal fistula response at week 12 2) Proportion of patients with perianal fistula remission at week 12 3) Proportion of patients with combined perianal fistula remission at week 12;Timepoint(s) of evaluation of this end point: 1) week 12 2) week 12 3) week 12 | — |
Countries
Austria, Belgium, Denmark, Germany, Hungary, Korea, Republic of, Netherlands, Spain
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co KG
Outcome results
None listed