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    Summary
    EudraCT Number:2019-000896-17
    Sponsor's Protocol Code Number:SBP-9200-HBV-206
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-000896-17
    A.3Full title of the trial
    A PHASE 2, EXPLORATORY STUDY EVALUATING THE SAFETY AND ANTIVIRAL EFFICACY OF INARIGIVIR SOPROXIL IN NON-CIRRHOTIC, HEPATITIS B e ANTIGEN NEGATIVE SUBJECTS INFECTED WITH CHRONIC HEPATITIS B VIRUS AND RECEIVING OR STOPPING TREATMENT WITH A NUCLEOSIDE/NUCLEOTIDE INHIBITOR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is an open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic hepatitis B virus (HBV) infection.
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 safety and antiviral efficacy study of inarigivir
    A.4.1Sponsor's protocol code numberSBP-9200-HBV-206
    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 SponsorSpring Bank Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportSpring Bank Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSpring Bank Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDon Mitchell
    B.5.3 Address:
    B.5.3.1Street Address35 Parkwood Drive, Suite 210
    B.5.3.2Town/ cityHopkinton
    B.5.3.3Post code01748
    B.5.3.4CountryUnited States
    B.5.4Telephone number508 689 9737
    B.5.5Fax number508 422 0951
    B.5.6E-maildmitchell@springbankpharm.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 nameInarigivir Soproxil
    D.3.2Product code SB9200
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic HBV-infected, HBeAg-negative subjects, who are non-cirrhotic and meet the cohort-specific criteria. Criteria for the planned cohorts are as follows:
    Cohort 1 Subjects who have been on NUC treatment for ≥3 years, have HBsAg <1000 IU at Baseline, and are planning to discontinue NUC therapy
    Cohort 2 Subjects who have been suppressed on a NUC for ≥1 year, and have HBV DNA below LLOQ, and are planning to continue NUC therapy
    E.1.1.1Medical condition in easily understood language
    Non cirrhotic Hepatitis B Viral infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 objectives are to identify safety and antiviral efficacy of inarigivir in participants receiving nucleoside/nucleotide (NUC) analogue inhibitors and in subjects who discontinue NUCs.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    Both cohorts:
    1. To evaluate markers of innate immunity in serum including interferon (IFN)-α, IFN-γ, tumor necrosis factor (TNF), interleukin-6 (IL-6), IL-10, and IFN-γ-inducible protein-10 (IP-10)
    2. To assess duration, predictive factors, and sustainability of antiviral effect.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects at selected sites may participate in an optional exploratory substudy of intrahepatic and peripheral immune response if they consent to do so. For both cohorts, there will be an optional substudy of samples collected by fine needle aspiration (FNA) and peripheral blood mononuclear cell (PBMC) samples collected at the times of FNA samples. Subjects who consent to participate in the substudy will sign a separate informed consent document specific to the substudy.
    The objectives of the optional substudy are to assess the following (both cohorts):
    1. Intrahepatic immune responses and virology as determined by FNA of liver
    2. Correlation of intrahepatic immune response with PBMC response
    E.3Principal inclusion criteria
    Participants in all cohorts must meet all the following inclusion criteria to be enrolled into the study:
    1. HBV-infected male and female participants aged 18 to 70 years, inclusive
    2. Ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) within 6 months of enrollment (Cohort 1) or randomisation (Cohort 2) date with no evidence of cirrhosis or hepatocellular carcinoma (HCC)
    3. Must be willing and able to comply with all study requirements
    4. Have HBV DNA <LLOQ at Screening
    5. ALT normal or, if elevated, <2× ULN with a documented etiology for elevation such as non-alcoholic fatty liver disease (NAFLD) confirmed by either ultrasound or controlled attenuation parameter (CAP) score >280 on elastography
    6. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of IP. If the urine pregnancy test is positive, a follow-up serum test is required for confirmation
    7. Women of childbearing potential must agree to use a highly effective method of contraception. Men with female partners who are of childbearing potential must agree that they or their partners will use a highly effective method of contraception.
    • Women of childbearing potential are sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (ie, who have not menstruated at all) for at least 1 year.
    • Highly effective methods of contraception are hormonal contraceptives (oral, injectable, patch, intrauterine devices), male partner sterilisation, or total abstinence from heterosexual intercourse, when this is the preferred and usual
    lifestyle of the participant.
    Note: The double-barrier method (eg, synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide only are not acceptable as highly effective methods of contraception.
    8. Must have the ability to understand and sign a written informed consent form (ICF); consent must be obtained prior to initiation of study procedures

    In addition, participants must meet the cohort-specific criteria listed below:
    Cohort 1:
    a. HBeAg-negative participants on documented NUCs for ≥3 years with undetectable HBV DNA by polymerase chain reaction (PCR) documented at least annually over the last 2 years. NUCs can include tenofovir, entecavir, telbivudine, lamivudine, adefovir, and tenofovir-5TC.
    b. HBsAg <1000 IU at Screening
    c. Planning to discontinue NUC therapy
    Cohort 2:
    a. HBeAg-negative participants on documented NUCs for ≥1 year with undetectable HBV DNA by PCR documented on at least 1 occasion in the last 6 months. NUCs can include tenofovir, entecavir, telbivudine, lamivudine, adefovir, and tenofovir-5TC.
    b. Planning to continue NUC therapy
    E.4Principal exclusion criteria
    Participants in all cohorts who meet any of the following exclusion criteria are not eligible to be enrolled into the study:
    1. Any prior liver biopsy evidence of metavir F3 or F4 disease
    2. Any history of decompensation of liver disease including history of ascites, encephalopathy, or varices
    3. Evidence of advanced fibrosis as defined by Fibroscan at the Screening Visit of ≥8 kPa. If Fibroscan is not available, participants with both a Fibrotest ≥0.65 and aspartate transaminase (AST):platelet ratio index (APRI) ≥1.0 are excluded (participants will not be excluded if only 1 of the Fibrotest or APRI results is higher than allowed)
    4. Laboratory parameters not within defined thresholds:
    4.1 White blood cells <4000 cells/μL (<4.0×109/L)
    4.2 Haemoglobin <11 g/dL (<110 g/L) for females, <13 g/dL (<130 g/L) for males
    4.3 Platelets <130,000 per μL (<130×109/L)
    4.4 Albumin <3.5 g/dL (<35 g/L)
    4.5 International normalised ratio (INR) >1.5
    4.6 Total bilirubin >1.2 mg/dL (>20.52 μmol/L) or alpha-fetoprotein (AFP) >50 ng/mL (>180.25 nmol/L). Participants with an elevated indirect bilirubin and limits. Participants with an AFP >50 ng/mL but <500 ng/mL can be included if CT scan or MRI performed within 3 months shows no evidence of HCC
    4.7 Creatinine >1.2 mg/dL (>106.08 μmol/L) and creatinine clearance <50 mL/min (<0.83 L/s/m2)
    5. Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus
    6. Evidence or history of HCC
    7. Malignancy within 5 years prior to Screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible
    8. Significant cardiovascular, pulmonary, or neurological disease
    9. Received solid organ or bone marrow transplant
    10. Received within 3 months of Screening or expected to receive prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, IFN)
    11. Participants currently taking medication(s) that are transported through organic anion transporting polypeptide 1 (OATP1) including, but not limited to, atazanavir, rifampin, cyclosporine, eltrombopag, gemfibrozil, lopinavir/ritonavir, and saquinavir
    12. Use of another investigational agent within 3 months of Screening
    13. Current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance
    14. Females who are pregnant or may wish to become pregnant during the study
    15. If the Investigator believes the prospective participant will not be able to comply with the requirements of the protocol and complete the study
    16. Any medical condition that, in the opinion of the Investigator, could interfere with evaluation of the study objectives or safety of the participants
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    1. The primary endpoint for safety is the proportion of subjects reporting an adverse event or experiencing a clinically significant adverse event or laboratory abnormality from start of treatment to end of inarigivir treatment and 30 days after stopping inarigivir
    2. Antiviral efficacy defined by the following:
    Cohort 1 (subjects who stop treatment with NUCs and start treatment with inarigivir):
    1. Reduction in quantitative HBsAg by >0.3 log10 from Baseline to Week 24
    2. Percentage of subjects with loss of HBsAg from Baseline to Weeks 24 and 48
    3. Percentage of subjects with ALT flares
    4. Percentage of subjects with suppression of HBV DNA <2000 IU/L at Weeks 24 and 48
    5. Percentage of subjects with ALT <40 IU/L at Weeks 24, 48, 72, and 96
    6. Percentage of subjects who lose HBsAg at Weeks 72 and 96
    Cohort 2 (subjects who continue treatment with NUCs and start treatment with inarigivir):
    1. Percentage of subjects with suppression of HBV DNA <2000 IU/L at Weeks 72 and 96 (off inarigivir treatment)
    2. Percentage of subjects with ALT <40 IU/L at Weeks 72 and 96 (off inarigivir treatment)
    3. Percentage of subjects with HBsAg <1000 IU at Weeks 72 and 96 (off inarigivir treatment)
    E.5.1.1Timepoint(s) of evaluation of this end point
    answered in question E.5.1
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    Both cohorts:
    Fold change from Baseline in serum levels of IFN-α, IFN-γ, TNF, IL-6, IL-10, and IP‑10 at all assessment timepoints
    Cohort 2 only:
    To evaluate the following:
    • Percentage of subjects with HBsAg decline >0.3 log10 at Weeks 12, 24, 48, 72, and 96
    • Percentage of subjects with HBsAg decline >0.5 log10 at Weeks 12, 24, 48, 72, and 96
    • Percentage of subjects with HBsAg loss at Weeks 24, 48, 72, and 96
    • Percentage of subjects with undetectable HBV DNA at Weeks 24, 48, 72, and 96
    • Percentage of subjects who suppress HBsAg <100 IU at Weeks 24, 48, 72, and 96
    • Change in serum HBV DNA, HBsAg, and HBV RNA in log10 IU/mL from Baseline to Weeks 12, 24, 48, 72, and 96
    E.5.2.1Timepoint(s) of evaluation of this end point
    answered in question E.5.2
    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 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) 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Canada
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 60
    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)
    There is no provision for additional course of study medication provided by Spring Bank Pharmaceuticals beyond the treatment defined in this protocol. Once the participant has been discontinued from the study, the participant’s doctor will continue to manage them according to the routine standard of care.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-07-16
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