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    Summary
    EudraCT Number:2019-004578-25
    Sponsor's Protocol Code Number:AUCH-1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-004578-25
    A.3Full title of the trial
    A randomised placebo-controlled safety study of Lactobacillus reuteri BGP-014 in patients with active mild to moderate ulcerative colitis
    Randomiserad placebokontrollerad säkerhetsstudie av Lactobacillus reuteri (BGP-014) för behandling av ulcerös kolit.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in patients with mild to moderate ulcerative colitis to test the tolerability of Lactobacillus reuteri BGP-014
    A.4.1Sponsor's protocol code numberAUCH-1
    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 SponsorBioGaia Pharma AB
    B.1.3.4CountrySweden
    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 supportBioGaia Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioGaia Pharma AB
    B.5.2Functional name of contact pointPetra Jones Lierud
    B.5.3 Address:
    B.5.3.1Street AddressBryggargatan 10
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code11121
    B.5.3.4CountrySweden
    B.5.4Telephone number46724504400
    B.5.6E-mailpetra.jones.lierud@biogaiapharma.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.3.1Product nameBGP-014 Capsules
    D.3.2Product code BGP-014
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLactobacillus reuteri
    D.3.9.2Current sponsor codeBGP-014
    D.3.9.3Other descriptive nameLACTOBACILLUS REUTERI
    D.3.9.4EV Substance CodeSUB32256
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2
    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 Yes
    D.3.11.13.1Other medicinal product typeLive biotherapeutic product (LBP)
    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 placeboCapsule, hard
    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
    Mild to moderate ulcerative colitis
    Mild till måttlig ulcerös kolit
    E.1.1.1Medical condition in easily understood language
    Mild to moderate ulcerative colitis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the safety and tolerability of BGP-014 compared to placebo in mild to moderate UC patients on SoC treatment.
    E.2.2Secondary objectives of the trial
    The exploratory objective is to explore the efficacy of BGP-014 compared to placebo in mild to moderate UC patients on SoC treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 The subject has given written consent to participate in the study.
    2 >18 years of age
    3 Diagnosed previously with UC (> 6 months earlier) determined by clinical and endoscopic
    histopathology (pathology showing chronic inflammatory changes). ≥1 documented previous
    flare-up and with last resolved flare >3 months away
    4 Active UC determined by sigmoidoscopy before randomisation of study (baseline) and
    defined as a total Mayo index score of 4 to 10 points
    5 Mayo endoscopic subscore ≥1 (Mayo subscore, Findings of flexible proctosigmoidoscopy,
    Appendix A)
    6 Rectal bleeding ≥1 (Mayo subscore, Rectal bleedings, Appendix A)
    7 Permitted concomitant SoC medications include:
    • Oral aminosalicylates (5-ASA), with a stable dose (1.6-4.8g/ day) for 14± 2 days prior to
    screening, Visit 1
    • Steroids (dose ≤15mg at screening, Visit 1) with further tapering of dose in accordance with
    SoC until steroid tx termination
    • Immunomodulator, as: 6-Mercaptopurine, Azathioprine, Methotrexate (Stable dose for > 12
    weeks prior to screening, Visit 1)
    8 In females of childbearing potential should be practicing at least 1 effective contraceptive
    method; oral or parenteral hormonal contraceptives; a vasectomized partner; or abstinence from sexual intercourse. The investigator will discuss with the subject the option of practicing at least 1 of the above methods for the duration of the study.
    E.4Principal exclusion criteria
    1 Involvement in any investigational drug or device study within 30 days prior to this study
    2 Known intolerance of 5-ASA or sulphasalazine medications
    3 Biologics or FMT treatment less than 12 weeks before screening
    4 No 5-ASA or steroid topical treatment is allowed
    5 Antibiotic treatment < 1 month prior the study
    6 Unable to maintain stable dose of NSAIDs and PPIs
    7 Evidence of on-going extensive colitis
    8 Fever, defined as a temperature of >38.5 °C, at Visit 1
    9 Anaemia, Hb value below 100
    10 Evidence of on-going toxic megacolon
    11 Presence of obstructive diseases of the gastrointestinal system
    12 Any clinically significant concomitant disease that might interfere with patient safety
    13 Unwilling to withdraw probiotic supplements. Yoghurts without supplemented bacteria are
    permitted
    14 Pregnant
    15 Planned abdominal surgery
    16 Judged unable by the physician to comprehend information regarding the study
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 6 weeks
    E.5.2Secondary end point(s)
    Exploratory efficacy Endpoints:
    • Proportion of patients with Clinical remission at week 6. Total Mayo score ≤2. (Defined
    further as Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore 0 and stool
    frequency subscore of 0 or a decrease from baseline of at least one unit.)
    • Proportion of patients with Clinical response at week 6. Total Mayo score improvement ≥3
    units. Reduction in rectal bleeding subscore at least 1 unit decrease from baseline.
    • Proportion of patients with Clinical response from baseline in modified Mayo score
    improvement ≥2 units or absolute resolution in modified Mayo subscores. Proportions of
    patients with reduction in rectal bleeding subscore at least 1 unit decrease from baseline.
    • Endoscopic improvement (Proportion of patients with decrease from baseline of at least 1
    unit in Mayo endoscopic score)
    • To evaluate the change from baseline in faecal calprotectin level
    • Proportion of patients with change from a level >200mg/kg to ≤50 mg/kg
    • Proportion of patients with change from a level >200mg/kg to ≤200 mg/kg
    • Time to symptom relief and symptom resolution based on PROs (Symptom relief defined as
    reduction of one unit from baseline in rectal bleeding subscore and/or stool frequency subscore. Symptom resolution is rectal bleeding subscore and/or stool frequency subscore of
    0.)
    • Change from baseline in abdominal pain. VAS scale from 10-0.
    • To evaluate the change from baseline in patient reported Short Health Scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.1.1First administration to humans Yes
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    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 Decision2021-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
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