A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease
- Conditions
- Fistulizing Crohn’s DiseaseMedDRA version: 20.0Level: LLTClassification code 10075465Term: Fistulizing Crohn's diseaseSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-003090-34-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method