Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44063   clinical trials with a EudraCT protocol, of which   7319   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004212-64
    Sponsor's Protocol Code Number:IMC-I109V-101
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-004212-64
    A.3Full title of the trial
    An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Patients with Chronic HBV who are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of IMC-I109V in non-cirrhotic HBeAg-negative chronic HBV infection
    A.3.2Name or abbreviated title of the trial where available
    IMC-I109V-101
    A.4.1Sponsor's protocol code numberIMC-I109V-101
    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 SponsorImmunocore Ltd
    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 supportImmunocore Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunocore Ltd
    B.5.2Functional name of contact pointSheetal Thakur
    B.5.3 Address:
    B.5.3.1Street Address92 Park Drive Milton Park
    B.5.3.2Town/ cityAbingdon
    B.5.3.3Post codeOX14 4RY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+12673007657
    B.5.6E-mailsheetal.thakur@immunocore.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 nameIMC-I109V
    D.3.4Pharmaceutical form Concentrate for 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeIMC-I109V
    D.3.9.3Other descriptive nameIMC-I109V
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.20
    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 Yes
    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 hepatitis B virus (HBV) infection
    E.1.1.1Medical condition in easily understood language
    chronic hepatitis B virus (HBV) infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019182
    E.1.2Term HBV
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019743
    E.1.2Term Hepatitis B virus (HBV)
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary (Part 1 – SAD)
    To evaluate the safety and tolerability of IMC-I109V when administered as a single dose in virally suppressed, HBeAg-negative participants
    Primary (Part 2 – MAD)
    To evaluate the safety and tolerability of IMC-I109V when administered in a multiple dose schedule up to Week 24 in virally suppressed, HBeAg-negative
    participants
    E.2.2Secondary objectives of the trial
    1) To characterize the PK profile of IMC-I109V in single dose and multiple dose schedules
    2) To evaluate incidence of anti-IMC-I109V antibody formations following single and multiple infusions
    3) To assess the antiviral effects of IMC-I109V following administration of SAD and MAD schedules using HBV biomarkers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 to 65 years inclusive, at the time of signing the informed consent.
    2. HLA-A*02:01 positive (central laboratory testing)
    3. Documented evidence of CHB based on one of the following:
    a. Positive HBsAg and HBV DNA at least 6 months prior to the screening visit; OR
    b. Historical liver biopsy consistent with CHB infection available.
    4. If previously HBeAg-positive, participants must be HBeAg-negative at the screening visit and have historical HBeAg-negative status >3 months prior to the screening visit available for review.
    5. Have been receiving entecavir and/or tenofovir (including tenofovir alafenamide) for ≥ 12 months prior to screening and are willing to continue.
    6. HBV DNA negative (below the LLOQ) at screening
    7. Quantitative HBV surface antigen ≤ 3000 IU/mL at the screening visit. Participants with HBsAg levels ≥ 3000 IU/mL and ≤ 5000 IU/mL may be eligible after consultation with, and approval by, the Sponsor’s Medical Monitor.
    8. All participants must have no history of liver cirrhosis AND prior assessment of fibrosis demonstrating non-cirrhotic status at screening as defined by one of the following:
    a. Liver biopsy demonstrating a Metavir Fibrosis Score of F0-2 (or equivalent); OR
    b. Fibroscan® result of < 9 kPa.
    NOTE: A confirmatory Fibroscan® is required within 6 months prior to Day 1.
    9. Liver imaging confirming absence of clinically significant abnormalities is required within 6 months prior to Day 1.
    10. Male and female participants of childbearing potential who are sexually active with a nonsterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of the study intervention or longer if required by local regulations; cessation of birth control after this point should be discussed with a responsible physician. *Male participants are not allowed to donate sperm from the time of enrollment until 3 months post-administration of study interventions or longer if required by local regulations.
    *Female participants must refrain from egg donation during the course
    of the study
    11. Capable of giving signed informed consent
    E.4Principal exclusion criteria
    Medical Conditions
    1. Known co-infection with any of the following:
    a. HIV
    b. Hepatitis C virus OR
    c. Hepatitis D virus
    2. Changes in HBeAg status within 3 months prior to the screening visit
    3. Known HBV genotype A
    4. Gilbert's syndrome
    5. Any known pre-existing medical or psychiatric condition that could interfere with the participant's ability to provide informed consent or participate in study conduct, or that may confound study findings
    6. Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia
    7. Evidence of active or suspected malignancy, or a history of malignancy ≤ 3 years prior to the screening visit (except adequately treated carcinoma in situ, basal cell carcinoma of the skin, or stage 0 HCC that has been treated). NOTE: Participants under evaluation for malignancy are not eligible
    8. Known or suspected hypersensitivity or previous severe reactions to any of the constituents of IMC-I109V, or the drugs used in the pretreatment
    regimen (eg, dexamethasone, ibuprofen and paracetamol)
    9. Pregnant or lactating women
    Prior/Concomitant Therapy
    10. Receiving or planning to receive systemic immunosuppressive medications during the study or ≤ 2 months prior to Day 1, including but not limited to prednisone > 10 mg/day (or equivalent), methotrexate, cyclosporine, or interferon. NOTE: Local steroid therapy are allowed (eg, inhaled, otic, ophthalmic, or intra-articular medications).
    Prior/Concurrent Clinical Study Experience
    11. Use of any live vaccines against infectious diseases within 4 weeks of the first planned administration of study intervention or use of any non-live vaccines against infectious diseases within 2 weeks of the first planned administration of study intervention.
    12. Treatment with any investigational drug or enrollment in any other clinical study ≤ 6 months prior to Day 1, or at any time during participation in the study
    Laboratory Exclusion Criteria
    13. If any of the laboratory exclusion criteria are met, then the site may have the participant retested. If a single value is within ±10% of the listed laboratory exclusion criterion value upon retest, and the value is considered to be not clinically significant by the physician investigator, the participant may be considered for enrollment:
    *ALT > 1.5 x ULN;
    *AST > ULN;
    *Total bilirubin and direct bilirubin > ULN;
    *Albumin < 32 g/L;
    *INR > 1.2;
    *Hematologic, biochemical, and serologic criteria (transfusions or growth factors may not be used to achieve study entry requirements):
    Hemoglobin < 110 g/L for females and < 120 g/L for males, Neutrophils < 1.5 x 109/L (African descent: < 1.2 x 109/L); Platelets < 120 x 109/L
    *Poorly controlled diabetes mellitus with whole blood hemoglobin A1c ≥8.5%.
    *Estimated glomerular filtration rate < 60 mL/min/1.73 m2
    *AFP > 200 ng/mL. NOTE: For participants with alpha-fetoprotein results of 50 to 200 ng/mL, a liver ultrasound, computerized tomography scan, or magnetic resonance imaging scan is required to rule out malignancy. Participants with elevated AFP may be eligible, provided malignancy is ruled out and after consultation with, and approval by, the Sponsor's Medical Monitor.
    Other Exclusions
    14. Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine ≤ 12 months prior to the screening visit, except for those participants monitored in an opioid substitution maintenance program
    15. Poor venous access that precludes routine peripheral blood sampling or intravenous (IV) infusion required for this study
    16. Participants who have a planned need for anesthesia for outpatient surgery or any other reasons during the study
    17. Employed as site personnel directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence and severity of treatment-emergent adverse events (TEAEs)
    • Incidence of dose-limiting toxicities (DLTs)
    • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF),
    • Incidence of serious adverse events (SAEs)
    • Incidence of adverse events (AEs) leading to treatment discontinuation
    Through 28 days after the last infusion of study treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through 28 days after the last infusion of study treatment
    E.5.2Secondary end point(s)
    IMC-I109V serum PK parameters (eg, AUC, Cmax, Tmax, t1/2) after single and multiple doses
    Incidence of anti-IMC-I109V antibody formation following administration of 1 or more doses of study drug
    HBsAg, hepatitis core-related antigen (HBcrAg), HBV RNA, HBsAb changes from baseline through end of trial
    E.5.2.1Timepoint(s) of evaluation of this end point
    -IMC-I109V serum PK parameters (eg, AUC, Cmax, Tmax, t1/2) after single and multiple doses
    - Incidence of anti-IMC-I109V antibody formation following administration of 1 or more doses of study drug
    SAD – W1D1 and W4D1
    MAD - pre-dose (dose 1, dose 3, dose 5, dose 16 and EOT (last dose) and Follow-up Week 24 (last FU week)
    - HBsAg, hepatitis B core-related antigen (HBcrAg), HBV RNA, HBsAb changes from baseline through end of trial
    SAD – W1D1, W1D3, W2D1, W3D1, W4D1, W5D1
    MAD - performed weekly Week 1-Week 8, then every 4 weeks during Week 8-Week 24
    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 No
    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) 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Australia
    Hong Kong
    Korea, Republic of
    New Zealand
    Poland
    Romania
    Spain
    Belgium
    Ukraine
    United Kingdom
    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
    LVLS
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 103
    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 state6
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 108
    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)
    The investigator will ensure that patients receive appropriate standard of care to treat the condition under the study
    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 Decision2020-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA