Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn*s Disease

Phase 2

Completed

• Conditions: chronic inflammation of digestive tract; Crohn disease; 10017969

• Registration Number: NL-OMON55434
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-03-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

Inclusion Criteria

1) 18-75 years at date of signing informed consent
2) Male or female patients. Women of childbearing potential must be ready and
able to use highly effective methods of birth control as mentioned in the
protocol.
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
and 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 of 250 or less.
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

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,
2) Rectovaginal fistulas
3) Anticipated to require surgical intervention for CD including any fistula
surgical procedures (except seton drainage).
4) Has an abscess that the investigator feels requires drainage beyond fistula
drainage with a
seton
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
• Study Design: Not specified