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A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03752970
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : April 16, 2019
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The primary objectives of this trial are:

  • To explore the pathomechanisms involved in the generation and healing of Crohn's Disease (CD) associated perianal fistulas
  • To understand the mode-of-action (MoA) of BI 655130 in patients with CD and draining perianal fistulas

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: BI 655130 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanism of Action and Clinical Effect of BI 655130 in Patients With Fistulizing Crohn's Disease
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: BI 655130 Drug: BI 655130
Solution for infusion

Placebo Comparator: Placebo Drug: Placebo
Solution for infusion

Primary Outcome Measures :
  1. Total number of deregulated genes [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Proportion of patients with perianal fistula response [ Time Frame: Week 12 ]
  2. Proportion of patients with perianal fistula remission [ Time Frame: Week 12 ]
  3. Proportion of patients with combined perianal fistula remission [ Time Frame: Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  • 18-75 years at date of signing informed consent
  • Male or female patients. Women of childbearing potential (WOCBP) 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. Restrictions regarding women of childbearing potential. Restrictions regarding contraception for female patients are not applicable for Screening Cohort.
  • Diagnosis of clinical Crohn´s Disease ≥ 4 months prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report
  • Has > 1 draining perianal fistulas (> 4 weeks duration before enrolment as a complication of Crohn's Disease (CD), confirmed by Magnetic Resonance Imaging (MRI) at screening) and a clinical indication to insert a seton drainage. For Screening Cohort a historical MRI is sufficient.
  • Additional enterocutaneous or abdominal fistulas are permitted (except rectovaginal fistulas)
  • Absent, mild or moderate clinical activity with Crohn's Disease Activity Index (CDAI)< 250. CDAI is not applicable for Screening Cohort.
  • 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: Immunosuppressive agents (e.g. thiopurines, methotrexate), TNFɑ antagonists (e.g. infliximab, adalimumab, certolizumab pegol; or respective biosimilars), vedolizumab, ustekinumab, azathioprine and / or antibiotics
  • 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).
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Gastrointestinal Exclusion Criteria (Study cohort only)

  • 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 perianal disease activity (PDAI) and Crohn's Disease Activity Index (CDAI) to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 655130
  • Rectovaginal fistulas
  • Anticipated to require surgical intervention for Crohn's Disease (CD)(except seton placement)
  • Has an abscess that the investigator feels requires drainage beyond fistula drainage with a seton (based on either clinical assessment or Magnetic Resonance Imaging (MRI))
  • Any kind of bowel resection or diversion within 6 months or any other intraabdominal surgery within 3 months prior to screening.
  • Ileostomy, colostomy or known fixed symptomatic stenosis of the intestine at screening.
  • Positive stool examinations for C. difficile or other intestinal pathogens < 30 days prior to screening
  • Evidence of colonic mucosal dysplasia or colonic adenomas, unless properly removed (properly according to the investigator's assessment)
  • Faecal transplant ≤ 6 months before screening
  • Treatment with:

    • any non-biologic medication (incl. cyclosporine, JAK inhibitors such as tofacitinib, tacrolimus, sirolimus, mycophenolate mofetile, S1P modulators, SMAD7 antisense inhibitors such as mongersen), other than those allowed within 30 days prior to randomisation or detectable plasma concentration
    • any biologic treatment approved for CD (adalimumab, infliximab, certolizumab pegol, vedolizumab or ustekinumab) within 8 weeks prior to randomization
    • any investigational or non-approved biologic for CD (including but not limited to IL-23 inhibitors) within 12 weeks prior to randomisation or etrolizumab within 8 weeks prior to randomization
    • rectal 5-ASA, rectal Tacrolimus, parenteral or rectal corticosteroids (incl. budesonide) within 2 weeks prior to randomisation
    • any antibiotics within 1 week prior to randomisation
    • any prior exposure to BI 655130
    • any chronic use of NSAID within 2 weeks prior to randomisation (occasional use of NSAIDs and acetaminophen for headache, arthritis, myalgias, menstrual cramps, etc., and daily use of baby or low dose (81-162.5mg) aspirin for cardiovascular prophylaxis are permitted)
    • any life-attenuated vaccines within 6 weeks prior to randomization

Infectious Disease Exclusion Criteria (Study cohort only)

  • Increased risk of infectious complications (e.g. due to past organ or stem cell transplantation)
  • Live or attenuated vaccination within 6 weeks prior to randomization
  • Patients with a positive QuantiFERON TB test during screening are excluded, unless:

    • Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practice/guidelines within the last 3 years and at least 6 months before first administration of trial medication under this protocol (patients may be re-screened once to meet this criterion)
    • Patients with suspected false positive or indeterminate QuantiFERON TB result may be re-tested once
    • If Quantiferon not available or providing indeterminate results after repeat testing : A tuberculin skin test reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent)
  • Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis. A patient can be re-screened if the patient was treated and is cured from the acute infection.

General Exclusion Criteria (Study cohort only)

  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix.
  • Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned during study conduct, e.g. hip replacement.
  • Pathological safety lab parameters: haemoglobin < 8 g/dL, total white blood count (WBC) < 3000 cells/μl, neutrophils < 1000 cells/μl, thrombocytes < 100.000/μl, creatinine ≥ 2 mg/dL, total bilirubin > 2 x ULN with ratio of direct/indirect >1 (patients with Gilbert's syndrome are not excluded), Alkaline Phosphatase >3 x ULN.
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Previous enrolment in this trial (exception: patients of screening cohort may be enrolled in study cohort)
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
  • Women who are pregnant, nursing, or who plan to become pregnant in the trial
  • Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than crohn´s disease, surgical procedure, medical examination finding (including vital signs and electrocardiogram (ECG)), or laboratory value at the screening visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data
  • History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients or to contrast media.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03752970

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Contact: Boehringer Ingelheim 1-800-243-0127

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AKH - Medical University of Vienna Recruiting
Wien, Austria, 1090
Contact: Walter Reinisch    +43 1 40400 47410   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Marc Ferrante    +32 16 34 88 56   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim Identifier: NCT03752970     History of Changes
Other Study ID Numbers: 1368-0008
2017-003090-34 ( EudraCT Number )
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://‐ clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link http://trials.boehringeringelheim. com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases