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    Summary
    EudraCT Number:2020-001317-20
    Sponsor's Protocol Code Number:IMCY-T1D-003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-03
    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 number2020-001317-20
    A.3Full title of the trial
    A Phase IIa, randomized, double-blind, dose comparison placebo-controlled, multi-centre clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect on the
    preservation of beta-cell function in adult patients with a recent onset Type 1 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMCY-0098 Proof of ACtion in Type 1 Diabetes - IMPACT Study
    A.4.1Sponsor's protocol code numberIMCY-T1D-003
    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 SponsorImcyse SA
    B.1.3.4CountryBelgium
    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 supportImcyse SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImcyse SA
    B.5.2Functional name of contact pointJean Van Ramperlbergh
    B.5.3 Address:
    B.5.3.1Street AddressAvenue pré-Aily 14
    B.5.3.2Town/ cityAngleur
    B.5.3.3Post code4031
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical@imcyse.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 IMCY-0098
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot availble yet
    D.3.9.2Current sponsor codeIMCY-0098
    D.3.9.3Other descriptive nameIMCY-0098
    D.3.9.4EV Substance CodeSUB188922
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number450 to 1350
    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 placeboPowder for suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 1 Diabetes
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067584
    E.1.2Term Type 1 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the change in stimulated C-peptide response during the first two hours of a mixed meal
    tolerance test (MMTT) from baseline to 48 weeks for the two doses of IMCY-0098 versus placebo.
    E.2.2Secondary objectives of the trial
    (1) To determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) from baseline to 12 and 24 weeks and to month 18 and month 24 for two doses of IMCY-0098
    (2) To determine the difference in Dried Blood Spots (DBS) fasted C-peptide between treatment and placebo groups from baseline to 48 weeks for the two doses of IMCY-0098.
    (3) To determine the changes in DBS C-peptide measurements until visit 11 comparing each dose with placebo.
    (4) To determine the effects of each dose of IMCY-0098 on HbA1c, hypoglycaemic events, Diabetes Ketoacidosis episodes, daily total insulin dose and CGM measures.
    (5)To evaluate the impact of IMCY-0098 at each dose on autoantibodies against GAD65, IA 2, ZnT8 and insulin over time.
    (6)To evaluate the safety features of IMCY-0098 at both doses.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Mechanistic sub-study for HLA DR4 negative /HLA DR3 positive participants: sub-study added in v3.0 (dated 26 Mar 2021) of the main study protocol.
    Up to 24 HLA DR4-/HLA DR3+ participants will be included in this mechanistic sub-study. The goal is to evaluate, characterize and compare the immune reaction of HLA DR4-/HLA DR3+ participants with the immune reaction of the HLA DR4+/HLA DR3+ participants included in the main study. The immune data acquired in this sub-population will be very informative to support decisions in terms of participant population for future clinical trials on adults but also on adolescents and children. Safety data will be collected and will contribute to the overall safety database for IMCY-0098.
    E.3Principal inclusion criteria
    (1) Have given written informed consent.
    (2) Participants aged ≥18 years and < 45 years at the time of consent.
    (3) Must have a diagnosis of T1D within maximum 9 weeks duration at screening (date of the first insulin injection).
    (4) Must have at least one or more diabetes-related autoantibodies present at screening (GAD65, IA-2, or ZnT8).
    (5) Must have random C-peptide levels ≥200 pmol/L measured at screening.
    (6) Must be HLA DR4 positive for the main study.
    a. Up to 24 participants with an HLA DR4 negative status but HLA DR3 positive will be eligible for the sub-study.
    (7) Must be willing to comply with intensive diabetes management.
    (8) Be treated with insulin therapy in accordance with local standard of care.
    (9) Males with reproductive potential must agree to use adequate contraception up to 90 days after the completion of the last treatment. This includes:
    - Barrier contraception (condom and spermicide) or
    - True abstinence (where this is in accordance with the participants preferred and usual lifestyle)
    (10) All females must have a negative serum pregnancy test at screening. Women sexually active and of childbearing potential must agree to use a highly effective contraception method from screening up to 90 days after last treatment with the investigational product.
    E.4Principal exclusion criteria
    (1) Clinically significant abnormal full blood count (FBC), renal function or liver function at screening, including
    a.Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL).
    b.Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal.
    c.Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal. Participants with elevated unconjugated bilirubin (Gilbert's syndrome) are eligible if bilirubin is ≤ 3 times the upper limits of normal and hepatic enzymes and function are otherwise normal (AST/ALT/Alkaline phosphatase within ULN), and there is no evidence of hemolysis.
    (2) Have signs or symptoms of serious active infection requiring IV antibiotics and/or hospitalization at study entry.
    (3) Have signs or symptoms of active COVID infection or a positive COVID PCR test during the screening period.
    (4) Has received any live, attenuated vaccine within 3 months prior to the first planned administration of the study product (which includes, but not limited to: oral poliomyelitis vaccine, measles-mumps-rubella vaccine, yellow fever vaccine, Japanese encephalitis vaccine, dengue vaccine, rotavirus vaccine, varicella vaccine, live-attenuated zoster vaccine, Bacillus Calmette-Guérin [BCG] vaccine, oral typhoid vaccine).
    (5) Be currently pregnant or lactating, or anticipate getting pregnant until at least 24 weeks after last study drug administration.
    (6) Require the use of immunosuppressive agents including chronic use of systemic steroids. Topical, inhalational or intranasal corticosteroids are allowed.
    (7) Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
    (8) Presence of any uncontrolled disease (including uncontrolled autoimmune disease) or abnormal clinical laboratory results that may interfere with study conduct as judged by the investigator.
    (9) History of, or current malignancy (except excised basal cell skin cancer).
    (10) Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within the 7 days prior to screening visit.
    (11) Active participation in another T1D treatment study or any investigational intervention study in the previous 30 days.
    (12) Known hypersensitivity to any component of the drug product.
    (13) CRO or Sponsor employees or employees under the direct supervision of the Investigator and/or involved directly in the study.
    (14) Be diagnosed with Latent Autoimmune Diabtes in Adults (LADA)
    E.5 End points
    E.5.1Primary end point(s)
    The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at baseline and 48 weeks in the IMCY-0098 groups compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    E.5.2Secondary end point(s)
    (1) The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT) at baseline, at 12 and 24 weeks and at month 18 and month 24 in the IMCY-0098 groups compared to placebo
    (2) The DBS C-peptide measurements from baseline to 48 weeks
    (3) The DBS C-peptide responses at each visit until visit 11
    (4)
    4.1.Change in HbA1c, from baseline to 24 and 48 weeks and to 18 and 24 months
    4.2.Number of treatment-emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA)
    4.3.Number of treatment-emergent episodes of diabetic ketoacidosis (DKA)
    4.4.Change in insulin requirements, baseline to 24 and 48 weeks and to 18 and 24 months as the daily total dose (three days average) in units per kg body weight (BW)
    4.5.Continuous glucose monitoring (CGM) time in range (70-180 mg/dL, 3.9-10.0 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range (<70 mg/dL, < 3.9 mmol/L) during 10 days at 12, 24 and 48 weeks and to 18 and 24 months compared to the reference period (first 10 days after randomization)
    (5) Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 24 and 48 weeks and to 18 and 24 months
    (6)
    6.1 Occurrence, intensity and relationship of any listed injection site and systemic AEs during a 7-day follow-up period (i.e., day of study product administration and 6 subsequent days) after each IMCY-0098 or placebo dose
    6.2 Occurrence, intensity and relationship of any unlisted injection site and AEs throughout the study period
    6.3 Occurrence and relationship of all SAEs throughout the study period
    6.4 Occurrence and relationship of any abnormality in physical examination, vital signs, 12-lead ECG
    6.5 Measure of CD4+/CD8+ lymphocytes ratio
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1) MMTT: D0, w12, w24, w48, M18, M24
    (2) The DBS C-peptide: at each visit
    (3)- HbA1c: D0, w12, w24, w48, M18, M24
    - # of treatment-emergent severe hypoglycaemic episodes: throughout the study period
    - # of treatment-emergent episodes of DKA: throughout the study period
    - Change in insulin requirements: D0, w24, w48, M18, M24
    - CGM: D0, w12, w24, w48, M24
    (4) GADA, IAA, IA-2A and ZnT8A: D0, w24, w48, M18, M24
    (5)- any listed injection site and systemic AEs: after each IMP administration (7days)
    - any unlisted injection site and AEs: throughout the study period
    - SAEs: throughout the study period
    - Physical examination: screening, (D0), w6, w12, w24, w48, M18, M24
    - vital signs: each visit
    - 12-lead ECG: screening, w12, w48, M24
    - CD4+/CD8+ ratio: at each visit
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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) 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 Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years2
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 84
    F.1.3Elderly (>=65 years) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation INNODIA
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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