A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 28

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 draining perianal fistulas (> 4 weeks duration before enrolment as a complication
of CD, confirmed by MRI at screening) and a clinical indication to insert a seton
drainage. For Screening Cohort a historical MRI is sufficient.
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

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 (except seton placement)
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: - To explore the pathomechanisms involved in the generation and healing of CD associated<br> perianal fistulas<br> - To understand the MoA of BI 655130 in patients with CD and draining perianal fistulas<br> ;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 Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1) Proportion of patients with perianal fistula response at week 12 <br> 2) Proportion of patients with perianal fistula remission at week 12<br> 3) Proportion of patients with combined perianal fistula remission at week 12<br> ;<br> Timepoint(s) of evaluation of this end point: 1) week 12<br> 2) week 12<br> 3) week 12<br>

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