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    Summary
    EudraCT Number:2017-001642-10
    Sponsor's Protocol Code Number:SMT19969/C005
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-02-19
    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 ConcernedLatvia - SAM
    A.2EudraCT number2017-001642-10
    A.3Full title of the trial
    A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment of Clostridium difficile infection (CDI).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of ridinilazole versus vancomycin treatment for Clostridium difficile infection
    A.4.1Sponsor's protocol code numberSMT19969/C005
    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 SponsorSummit (Oxford) Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBARDA
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportSummit (Oxford) Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSummit (Oxford) Limited
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address136A Eastern Avenue, Milton Park
    B.5.3.2Town/ cityAbingdon
    B.5.3.3Post codeOX14 4SB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441235443939
    B.5.6E-mailridinilazolephase3studies@summitplc.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 nameRidinilazole
    D.3.2Product code SMT19969
    D.3.4Pharmaceutical form 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 INNRidinilazole
    D.3.9.1CAS number 308362-25-6
    D.3.9.2Current sponsor codeSMT19969
    D.3.9.3Other descriptive nameSMT19969
    D.3.9.4EV Substance CodeSUB85907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 RoleComparator
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameVancomycin
    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 INNvancomycin
    D.3.9.3Other descriptive nameVANCOMYCIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB05077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    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 placeboCoated 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 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
    Clostridium difficile infection (CDI)
    E.1.1.1Medical condition in easily understood language
    Infection of the gut by the bacterium Clostridium difficile
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10054236
    E.1.2Term Clostridium difficile infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of 10 days dosing with ridinilazole (200 mg bid) with vancomycin (125 mg qid) in the treatment of patients with CDI
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability of 10 days dosing with ridinilazole (200 mg bid) with vancomycin (125 mg qid) in the treatment of patients with CDI
    • To assess the relative effect of ridinilazole (200 mg bid) with vancomycin (125 mg qid), at the end of treatment, on the relative abundance and diversity of the microbiome and bile salt composition of faecal samples
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if all the following criteria apply:
    1. Patient must be at least 18 years of age, at the time of signing the informed consent.
    2. Have signs and symptoms of CDI including diarrhea such that in the Investigator’s opinion CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 UBMs (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization.
    3. Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must be current (produced within 72 hours prior to randomization).
    4. Male or Female
    Male patients:
    • A male patient must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.
    Female patients:
    • A female patient is eligible to participate if she is not pregnant (see Section 10.4), not breastfeeding, and at least one of the following conditions applies:
    i. Not a woman of childbearing potential (WOCBP) as defined in Section 10.4
    OR
    ii. A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 30 days after the last dose of study treatment.
    5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]). If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC).
    E.4Principal exclusion criteria
    Patients are excluded from the study if any of the following criteria apply:
    1. Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months prior to randomization.
    2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
    3. Have had a positive diagnostic test for other GI pathogens considered to be clinically relevant, within 2 weeks of randomization.
    4. Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not include appendectomy) The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
    5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
    6. History of bone marrow or hematopoietic stem cell transplant at any time or a known current history of a severely compromised/supressed immune system that, in the opinion of the Investigator, would make the patient unsuitable for the study.
    7. Have had more than the equivalent 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole).
    8. Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization.
    9. Are unable to discontinue products used affecting disease progression at randomization (see 6.5.1 for a list of potentially confounding medications).
    10. Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI.
    11. Have received an investigational vaccine against C. difficile.
    12. Patients that the Investigator feels are inappropriate for the study this would include those;
    a. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study.
    b. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason. E.g. short life expectancy.
    c. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
    d. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws.
    E.5 End points
    E.5.1Primary end point(s)
    Sustained clinical response defined as clinical cure at the Assessment Of Cure (AOC) visit and no recurrence of CDI within 30 days post End Of Treatment (EOT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 40
    E.5.2Secondary end point(s)
    Clinical cure at the AOC visit.

    Sustained clinical response over 60 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 60 days post EOT

    Sustained clinical response over 90 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 90 days post EOT

    Investigator assessment of clinical cure at the AOC visit

    Investigator assessment of sustained clinical response at 30, 60- and 90-days post EOT

    Relative abundance and diversity of the microbiome and bile salt composition in fecal samples at the end of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Clinical cure at the AOC visit: Day 12 (AOC)

    • Sustained clinical response over 60 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 60 days post EOT: Day 70

    • Sustained clinical response over 90 days – defined as clinical cure at the AOC visit and no recurrence of CDI within 90 days post EOT: day 100

    •Investigator assessment of clinical cure at the AOC visit

    •Investigator assessment of sustained clinical response at 30, 60- and 90-days post EOT: Day 40, Day 70, and Day 100

    •Relative abundance and diversity of the microbiome and bile salt composition in fecal samples at the end of treatment: EOT (samples collected at Day 10 or Day 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 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 Yes
    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) No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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
    Belarus
    Canada
    Chile
    Georgia
    Israel
    Mexico
    Peru
    United States
    Belgium
    Estonia
    France
    Germany
    Latvia
    Lithuania
    Romania
    Spain
    Czechia
    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
    The end of the study is defined as the date of the last study assessment of the last patient in the study.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC).
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    persons in nursing homes
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 324
    F.4.2.2In the whole clinical trial 680
    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 Decision2019-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-11-19
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