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    Summary
    EudraCT Number:2020-004527-16
    Sponsor's Protocol Code Number:1425-0003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-19
    Trial 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004527-16
    A.3Full title of the trial
    A Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s Disease
    A.4.1Sponsor's protocol code number1425-0003
    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.1.3.4CountryGermany
    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 pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+498002430127
    B.5.5Fax number+498008217119
    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 706321
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet assigned
    D.3.9.1CAS number 2205041-37-6
    D.3.9.2Current sponsor codeBI 706321 XX
    D.3.9.3Other descriptive nameBI706321
    D.3.9.4EV Substance CodeSUB197459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 2
    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 706321
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet assigned
    D.3.9.1CAS number 2205041-37-6
    D.3.9.2Current sponsor codeBI 706321 XX
    D.3.9.3Other descriptive nameBI706321
    D.3.9.4EV Substance CodeSUB197459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 3
    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 706321
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet assigned
    D.3.9.1CAS number 2205041-37-6
    D.3.9.2Current sponsor codeBI 706321 XX
    D.3.9.3Other descriptive nameBI706321
    D.3.9.4EV Substance CodeSUB197459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn`s Disease (CD)
    E.1.1.1Medical condition in easily understood language
    Crohn`s Disease is a gastrointestinal disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objectives of this trial are to investigate a first signal of efficacy, safety and tolerability of BI 706321 in combination with ustekinumab treatment compared to placebo with ustekinumab treatment in patients with moderately to severely active CD at 12 weeks.

    The primary objective is to estimate the difference in change from baseline in Simple Endoscopic Score for Crohn’s disease (SES-CD) after 12 weeks. The primary treatment comparison will be between treatment groups while on treatment during the 12 week induction period.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients.
    2. ≥ 18 – ≤ 75 years, at date of signing informed consent.
    3. Diagnosis of CD for at least 3 months prior to visit 1,as confirmed at
    any time in the past by endoscopy and/or radiology, and supported by histology.
    4. Elevated CRP (≥ 5 mg/L) OR elevated fecal calprotectin (≥ 250 μg/g)
    5. Symptomatic CD defined as ≥ CDAI 150
    6. Presence of mucosal ulcers in at least one segment of the ileum or colon and a SESCD score ≥ 7 (for patients with isolated ileitis ≥4), as assessed by ileo-colonoscopy and confirmed by central independent reviewer(s) before start of study treatment.
    7. Patients who are experienced to 1 or 2 TNF antagonists (i.e. biosimilars of a drug are counted as the originator drug, e.g. the switch from infliximab originator to CT-P13 will count as one TNF antagonist exposure) at a dose approved for CD. Patients may have stopped TNF antagonists treatment due to primary or secondary nonresponsiveness, intolerance (see definitions in Appendix 10.7), or for other reasons.
    8. May be receiving a therapeutic dose of the following:
    o Oral 5-ASA compounds must have been at a stable dose for at least 4 weeks prior to randomisation and must continue on this dose until week 12 and/or
    o Oral corticosteroids if indicated for treatment of CD must be at a prednisone equivalent dose of ≤ 20 mg/day, or ≤ 9 mg/day of budesonide, and have been at a stable dose for at least 2 weeks immediately prior to randomisation and must continue on this dose until week 12. [Allowed steroid treatments: Locally administered steroids as e.g. intra-articular, nasal inhalation or intra-ocular
    administration are allowed.] and/or
    o AZA, MP, or MTX, provided that dose has been stable for the 8 weeks immediately prior to randomisation and must continue on this dose until week 12.
    9. Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per International Councila on Harmonisation (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 is provided in the patient information or in Section 4.2.2.3.
    10. Signed and dated written informed consent in accordance with ICH- Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
    E.4Principal exclusion criteria
    1. Have any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to rand and are not anticipated to require surgery. Patients with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present based on investigator`s judgement
    2.Have comp. of CD such as strictures, stenosis, short bowel syndrome, or any other manifestation that might require surgery, or could preclude the use of SESCD/ CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with BI 706321
    3.Patient with an inflammatory bowel disease (IBD) diagnosis other than CD
    4. Have had any kind of bowel resection or diversion within 4 months or any other intraabdominal surgery within 3 months prior to visit 1. Patients with current ileostomy, colostomy, or ileorectal anastomosis are excluded
    5.Treatment with any non-biologic medication for IBD (tacrolimus or mycophenolate mofetil, systemic corticosteroids), other than those allowed per inclusion criteria, within 30 days prior to rand any biologic treatment with a TNF-alpha antagonist (adalimumab, infliximab, golimumab, certolizumab pegol) or vedolizumab within 4 weeks prior to rando. (If drug level testing for previously used biologic treatment confirms no detectable drug level before rand, patient can be enrolled despite not having completed 4 week from last treatment) any previous treatment with ustekinumab any previous treatment with an investigational non-biologic or biologic drug for CD any investigational drug for an indication other than CD during the course of the actual study and within 30 days or 5 half-lives (whichever is longer) prior to rand any prior exposure to rituximab within 1 year prior to randomisation
    6. Positive stool examination for C difficile (toxin A/B and GDH ag – test positive) or other intestinal pathogens <30 days prior to randomisation
    Re screening can be undertaken following documented successful treat, no sooner than 1 week after last intake of antimicrobial therapy. If stool examination for C. Diff is indeterminate (toxin A/B pos and GDH antigen negative or toxin A/B negative and GDH antigen pos), a reflex PCR test must be done to assess eligibility. A positive PCR test will lead to excl
    7. Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed
    8. Fecal transplant ≤ 30 days prior to rand
    9. Increased risk of infectious complics (e.g. recent pyogenic inf, any congenital or acquired immunodeficiency (e.g. Human immunodeficiency virus), past organ or stem cell transplantation (with exception of a corneal transplant > 12 weeks prior to screening) or have ever received stem cell therapy (e.g., Prochymal). Prior treatment with a somatic cell therapy product (e.g., Alofisel) is not excluded, provided it was administered > 8 w prior to randomiz
    10. Live or attenuated vaccination within 4 weeks prior to rand
    11. Have received BCG vaccines ≤ 1 year prior to randomisation
    12. Active or latent TB:
    - Patients with active tuberculosis are excluded.
    - Patients will be screened with Interferon Gamma Release Assay (IGRA) such as QuantiFERON or T spot, the patient may also be evaluated for the presence of TB with any additional test required by
    local practice. Patients with positive test results are excluded unless patient is known to have had a 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 rescreened once
    to meet this specific criterion)
    - Patients with indeterminate QuantiFERON or invalid/borderline T spot may be re-tested with IGRA (once), and if again inconclusive, should have a Purified Protein Derivative (PPD) skin test.
    - If IGRA is not available or result remains indeterminate after repeat
    testing, tuberculin skin test (TST) should be performed: A tuberculin skin
    test positive reaction ≥10mm (≥5mm if receiving ≥15mg/d prednisone
    or its equivalent) is considered positive. Patients with a positive TST are
    excluded unless they have completed treatment as above.
    13.Presence of clinically significant acute or chronic infections not
    otherwise listed, including viral hepatitis, COVID-19, or others based on
    investigator's judgement. A patient can be rescreened (up to two times)
    if the patient was treated and is cured from the acute infection. If at
    screening, PCR test for SARS-CoV-2 is positive and patient is
    asymptomatic, re-test SARS-COV-2 PCR test is allowed (up to 4 times) to
    confirm patient's eligibility before ileo-colonoscopy and/or visit 2. If re
    test SARS-COV-2 PCR test is negative, patient must meet all other
    eligibility criteria according to the CTP before patient is randomized at
    visit 2. Already performed screening assessment do not need to be
    repeated
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change from baseline in Simple Endoscopic Score for Crohn’s disease (SES-CD) at week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints:
    - Percent change in SES-CD from baseline at Week 12
    - Endoscopic response (defined as ≥50% SES-CD reduction from baseline) or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline) at Week 12
    - Endoscopic response (defined as ≥50% SES-CD reduction from baseline or for a induction baseline SES-CD of 4, at least a 2 point reduction from induction baseline)) at Week 48
    - Endoscopic remission (defined as SES-CD score of ≤2) at week 12
    - Endoscopic remission (defined as SES-CD score of ≤2) at week 48.
    - Biological remission, defined as C-reactive protein (CRP) <5 mg/L and faecal calprotectin (FCP) < 250 ug/g at week 12
    - Biological remission, defined as CRP < 5 mg/L and FCP <250 ug/g at week 48
    - Clinical remission at week 12, defined as a Crohn’s Disease Activity Index (CDAI) score of <150
    - Clinical remission at week 48, defined as a CDAI score of<150
    - Clinical response at week 12, defined by a CDAI reduction from baseline of at least 100 points, or a CDAI score of <150
    - Number of patients with treatment-emergent adverse event(TEAE) through end of treatment (EoT) and the residual
    effect period (REP) (i.e. through Visit 9)
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    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 No
    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 trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Belgium
    Czechia
    Hungary
    Italy
    Poland
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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
    last visit of the last patient in the whole trial (“Last Patient Completed”).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 50
    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 Decision2021-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-23
    P. End of Trial
    P.End of Trial StatusOngoing
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