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    The EU Clinical Trials Register currently displays   43207   clinical trials with a EudraCT protocol, of which   7151   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-004230-28
    Sponsor's Protocol Code Number:1368-0005
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2017-004230-28
    A.3Full title of the trial
    A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy
    Randomizovaná, dvojitě zaslepená, placebem kontrolovaná, multicentrická studie fáze II/III hodnotící bezpečnost a účinnost indukční terapie přípravkem BI 655130 u pacientů se středně těžkou až těžkou aktivní ulcerózní kolitidou, u kterých selhala předchozí biologická léčba
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis
    Indukční léčba přípravkem BI 655130 u pacientů se středně závažnou až závažnou ulcerózní kolitidou
    A.4.1Sponsor's protocol code number1368-0005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim International GmbH
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim International GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim International GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim an Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number00498002430127
    B.5.5Fax number00498008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BI 655130
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBI 655130
    D.3.9.2Current sponsor codeBI 655130
    D.3.9.3Other descriptive nameMONOCLONAL ANTIBODY ANTI-IGG1
    D.3.9.4EV Substance CodeSUB31544
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate-to-severely active ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Moderate-to-severely active ulcerative colitis
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To prove the concept of clinical activity of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments and to identify efficacious and safe dose regimens in Part 1 (Phase II)
    E.2.2Secondary objectives of the trial
    - To confirm efficacy and safety of BI 655130 in patients with moderate-to-severely active ulcerative colitis who have failed previous biologic treatments in Part 2 (Phase III)
    - To provide, along with induction study 1368-0018 and the run-in cohort of 1368- 0020, the target population to be evaluated in the randomised withdrawal study 1368- 0020.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 - 75 years, at date of signing informed consent, males or females
    2. Diagnosis of ulcerative colitis ≥ 3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report
    3. Moderate to severe activity (total MCS 6 to 12 with a RBS ≥ 1 AND an SFS ≥ 1 AND mESS ≥ 2 within 7-28 days prior to first dose)
    4. Endoscopic activity extending proximal to the rectum (≥ 15 cm from anal verge)
    5.Well-documented demonstration of inadequate response or loss of response or have had unacceptable side effects with approved doses of TNFɑ agonists (infliximab, adalimumab, golimumab) and/or vedolizumab in the past as per definition in the CTP Appendix 10.6
    6. May be receiving a therapeutic dose of the following:
    - Oral 5-ASA compounds, provided that dose has been stable for at least the 4 weeks immediately prior to randomisation, and/or
    - Oral corticosteroids (≤ 20 mg per day of prednisone or equivalent), provided that dose has been stable for the 2 weeks immediately prior to randomisation, and/or
    - Oral budesonide (≤ 9 mg per day ) or beclomethasone dipropionate (≤ 5 mg per day), provided that dose has been stable for the 2 weeks immediately prior to randomisation, and/or
    - Azathioprine, 6-MP or methotrexate, provided that dose has been stable for the 8 weeks immediately prior to randomisation.
    - Probiotics (e.g. S. boulardii) provided that dose has been stable for the 4 weeks immediately prior to randomisation.
    7. Patients with extensive colitis or pancolitis of >10 years duration or family history of colorectal cancer or personal history of increased colorectal cancer risk must have had a negative colorectal cancer screening within <1 year prior to enrolment (otherwise to be done during screening colonoscopy).
    8. Women of childbearing potential (WOCBP) must be ready 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.
    9. Signed and dated written informed consent for 1368.5, in accordance with GCP and local legislation prior to admission into the trial
    E.4Principal exclusion criteria
    1. Evidence of abdominal abscess at screening
    2. Evidence of fulminant colitis or toxic megacolon at screening
    3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
    4. Treatment with:
    •any non-biologic medication (e.g. cyclosporine, tacrolimus or mycophenolate mofetil, intavenous corticosteroids, tofacitinib),
    •any biologic treatment with a TNFα antagonist (adalimumab, infliximab, golimumab) or vedolizumab within 8 weeks prior to randomisation
    (If drug level testing for previously used biologic treatment confirms no detectable drug level before randomization, patient can be enrolled despite not having completed 8 weeks from last treatment).
    •rectal 5-ASA, parenteral or rectal corticosteroids (incl. budesonide) within 2 weeks prior to screening
    •any investigational non-biologic drug for UC (including but not limited to JAK inhibitors, S1P modulators) within 30 days prior to randomisation
    •any investigational biologic for UC (including but not limited to ustekinumab and other IL-23 inhibitors) within 12 weeks prior to randomisation (except etrolizumab: within 8 weeks prior to randomisation)
    (If drug level testing for previously used biologic treatment confirms no detectable drug level before randomization, patient can be enrolled despite not having completed 8 weeks from last treatment).
    •any prior exposure to BI 655130, natalizumab or rituximab
    5. Positive stool examinations for C. difficile or other intestinal pathogens < 30 days prior to screening.
    (toxin A/B – test positive).
    6. have had previous surgery or are anticipated to require surgical intervention for UC
    7. Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed
    8. Primary sclerosing cholangitis
    9. Faecal transplant ≤ 30 days prior to randomisation
    10. Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital
    or acquired immunodeficiency (e.g. HIV), past organ or stem cell transplantation)
    11. Live or attenuated vaccination within 6 weeks prior to screening
    12. Active or latent TB: Patients with a positive TB test during screening are
    excluded, unless :
    •Patient had previous diagnosis of active or latent TB and has completed appropriate treatment per local practise /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)
    •A positive QuantiFERON TB (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 tuberculin skin test should be performed : Tuberculin skin test positive reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone or its equivalent)
    13. 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.
    14. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin, or history of cervical cancer in situ (treated >3years); patients with remote history of malignancy (≥5 years prior) may be considered and have to be discussed with sponsor case-by-case
    15. 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.
    16. Pathological safety lab parameters: haemoglobin < 9 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. – measured and confirmed by Central laboratory at screening visit.
    17. Currently enrolled in another investigational device or drug study.
    18. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
    19. Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than ulcerative colitis, 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
    20. Any psychiatric or social problems possibly interfering with ability to comply with all study visits/procedures
    21. History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients.
    E.5 End points
    E.5.1Primary end point(s)
    1. Part 1 and Part 2: Proportion of patients with Clinical Remission at week 12 (defined as mMCS SFS=0 or 1, if drop ≥1 from BL; and RBS=0; and mESS≤1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 12
    E.5.2Secondary end point(s)
    1. Part 2/Phase III only: Proportion of patients with Mucosal Healing at week 12 (defined as mESS ≤ 1)
    2. Part 2/Phase III only: Change in IBDQ score from baseline at week 12
    3. Part 1 and Part 2: Proportion of patients with combined Mucosal healing and histologic remission at week 12 (defined as mESS ≤ 1 and Robarts Histology Index ≤ 6)
    4. Part 2/Phase II only: Proportion of patients with Mucosal Healing at week 12
    5. Part 2/Phase II only: Proportion of patients with Clinical response at week 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 12
    2. Week 0 and Week 12
    3. Week 12
    4. Week 12
    5. Week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers associated with Ulcerative Colitis and the IL-36R pathway
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Canada
    China
    Czech Republic
    Denmark
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 254
    F.4.2.2In the whole clinical trial 550
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-18
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