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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   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).

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    Summary
    EudraCT Number:2017-002871-24
    Sponsor's Protocol Code Number:AG019-T1D-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:2018-05-30
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-002871-24
    A.3Full title of the trial
    A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in patients with clinical recent-onset Type 1 Diabetes Mellitus (T1D)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in patients with clinical recent-onset Type 1 Diabetes Mellitus (T1D)
    A.4.1Sponsor's protocol code numberAG019-T1D-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 SponsorIntrexon T1D Partners, LLC (IT1D)
    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 supportIT1D
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntrexon Actobiotics NV, d/b/a ActoBio Therapeutics
    B.5.2Functional name of contact pointSven Blomme
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7 C Building D
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)479 93 53 23
    B.5.6E-mailsblomme@actobio.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 nameAG019
    D.3.4Pharmaceutical form Gastro-resistant 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 INNUnknown
    D.3.9.1CAS number Unknown
    D.3.9.2Current sponsor codeAG019
    D.3.9.3Other descriptive nameAG019
    D.3.9.4EV Substance CodeSUB192089
    D.3.10 Strength
    D.3.10.1Concentration unit million CFU million colony forming units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    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 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 nameTeplizumab
    D.3.4Pharmaceutical form 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 INNTeplizumab
    D.3.9.1CAS number 876387-05-2
    D.3.9.2Current sponsor codeMGA031
    D.3.9.3Other descriptive nameTEPLIZUMAB
    D.3.9.4EV Substance CodeSUB35383
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant capsule, hard
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recent-onset Type 1 Diabetes mellitus (T1D)
    E.1.1.1Medical condition in easily understood language
    Recent-onset Type 1 Diabetes mellitus (T1D)
    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 assess the safety and tolerability of different doses of AG019 alone as well as in association with teplizumab.
    E.2.2Secondary objectives of the trial
    To obtain pharmacodynamics (PD) data of AG019 alone as well as AG019 in association with teplizumab

    To determine the potential presence of sAGX0407 or its secreted proteins in systemic circulation (safety – systemic exposure) and the presence of L. lactis bacteria in fecal excretion (local exposure): pharmacokinetic (PK) profile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or non-pregnant, non-lactating females, 18-40 years of age (both inclusive) or 12-17 years of age (both inclusive)
    - Diagnosis of diabetes according to the ADA recommended criteria
    - Evidence of auto-antibodies to at least 1 of the following β-cell autoantigens: insulin, IA-2, GAD65, ZnT8
    - Stimulated C-peptide measured during 4h Mixed Meal tolerance Test (MMTT) > 0.2 nmol/L
    - The first administration of AG019 should occur no later than 150 days post diagnosis
    - Body weight ≥ 33kg
    - Willing and medically able to postpone live vaccine immunizations for at least 8 weeks after randomization
    - Ability and willingness of patients to participate fully in all aspects of this clinical study
    - Written informed consent obtained and documented
    - Willingness to use a continuous glucose monitoring device and willingness to comply with the protocol defined glucose monitoring
    - Total bilirubin ≤1.0 x upper limit of normal (ULN), Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤1.5 x ULN, ≥1,000 lymphocytes/µL, ≥1,000 polymorphonuclear neutrophils (PMN)/µL, ≥100,000 platelets/µL, Hgb ≥10 g/dL, Serum Creatinin ≤1.5 x ULN, eGFR ≥60 mL/min/1.73m², INR ≤0.1 above upper limit of normal, Absence of clinically significant age appropriate abnormalities on all other lab values, except for abnormalities directly attributable to T1D
    E.4Principal exclusion criteria
    - Previous history of serious cytokine release syndrome to teplizumab or other humanized anti-CD3 monoclonal antibodies with no or minimal capacity to bind Fc receptors
    - Current use of any systemic antibiotics, except for the following: metronidazole (metronidazole), nalidixic acid (first generation quinolone), trimethoprim, sulfamethoxazole (sulfonamide) and/or a combination of both in a ratio 1/19 (sulfonamides)
    - Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization
    - Participation in another investigational drug trial within 12 weeks prior to the first study drug intake and during participation in this study
    - History of recurrent infections, other autoimmune diseases, cardiac disease, malignancy, or any other (chronic) medical condition which, in the investigator’s opinion, could compromise participant safety
    - Documented history of human immunodeficiency virus (HIV), Hepatitis Virus Type C (HCV), Hepatitis Virus Type B (HBV) infection
    - Evidence of active infection with Epstein-Barr Virus (EBV) or cytomegalovirus (CMV)
    - Untreated hypothyroidism or active Graves’ disease
    - Evidence of any active infection with the exception of superficial skin infections
    - Vaccination with live virus or organism within 8 weeks prior to randomization
    - Evidence of active or latent tuberculosis (TB)
    - Administration of anti-CD3 antibody in past year
    - Current therapy with any other anti-diabetic agents other than insulin (MDI, CSII or analogue). Current or planned therapy with experimental (i.e., unapproved) insulin
    - Use of medications known to influence glucose tolerance
    - Daily use of non-steroidal anti-inflammatory agents
    - Compromised GI mucosal integrity or motility, not attributable to T1D (i.e., recent diarrhea, gluten sensitive enteropathy, inflammatory bowel disease, irritable bowel syndrome), or current use of medications known to influence GI motility
    - Inability to swallow size 1 capsules
    - Alcohol or illicit drug consumption, which in the opinion of the investigator, may interfere with the patient’s ability to comply with the study procedures
    - Active psychiatric problems, which in the opinion of the investigator, may interfere with the patient’s ability to comply with study procedures
    E.5 End points
    E.5.1Primary end point(s)
    Analysis of the incidence of treatment-emergent adverse events (TEAEs) collected up to the 6-month follow-up visit.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cohorts 1-4 (AG019 only): Study day 1, 4, 7, 12, 28, 56, 90, 180
    Cohorts 5-6 (AG019 + teplizumab): Study day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 28, 56, 90, 180
    E.5.2Secondary end point(s)
    The PD activity of the study drug(s) will be assessed by measurement of biomarkers in blood and serum samples. Relevant parameters will be assessed, including immune markers for effect, relevant T1D parameters and relevant cytokines.

    Following parameters will be assessed for analysis of systemic and local exposure to L. lactis (PK profile):
    • Presence of live L. lactis clinical strain bacteria in whole blood
    • Measurable serum levels of hIL-10 and hPINS
    • Presence of L. lactis clinical strain bacteria in fecal excretion

    Safety information collected at all other time points will be assessed as secondary end points.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PD: Study day1, 12, 56, 180, 270 and 360
    PK: Study day 12, 56 and 90
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Phase 1b:Not controlled, open; Phase 2a: controlled, double blind, parallel group, placebo
    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 trial6
    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 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
    United States
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 24
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 24
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 48
    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 Decision2018-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-13
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