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

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2017-003090-34-DE
• Date of registration: 15/11/2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
• Public title: A study testing how BI 655130 works in patients with fistulizing Crohn’s Disease
• Scientific title: Mechanism of Action and Clinical Effect of BI 655130 in Patients with fistulizing Crohn’s Disease - BI 655130 treatment of fistulizing CD
• Date of first enrolment: 18/02/2019
• Target sample size: 28
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003090-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Denmark, Germany, Hungary, Korea, Republic of, Netherlands, Spain

Contacts

• Name: CT Disclosure & Data Transparency
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

• Name: CT Disclosure & Data Transparency
• Affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG

Key inclusion & exclusion 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. 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

Exclusion criteria:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Fistulizing Crohn’s Disease
MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: BI 655130
Product Code: BI 655130
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Spesolimab
Current Sponsor code: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

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

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 Objective: -

Secondary Outcome(s)

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

Secondary ID(s)

2017-003090-34-AT

1368-0008

Source(s) of Monetary Support

Boehringer Ingelheim Pharma GmbH & Co. KG

Ethics review

Status: Approved
Approval date: 25/01/2019
Contact: