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    The EU Clinical Trials Register currently displays   43936   clinical trials with a EudraCT protocol, of which   7310   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:2022-001713-39
    Sponsor's Protocol Code Number:TCD601F201
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2022-001713-39
    A.3Full title of the trial
    A 12-month, randomized, single-blind, placebo-controlled exposure-response study of TCD601 (siplizumab) in new onset type 1 diabetes patients (STRIDE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A one year, randomized, placebo-controlled study of TCD601 (siplizumab) in newly diagnosed patients with Type 1 diabetes
    A.4.1Sponsor's protocol code numberTCD601F201
    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 SponsorITB-MED AB
    B.1.3.4CountrySweden
    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 supportITB-MED AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationITB-MED AB
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressSonja Kovalevskys Gata 4
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code11366
    B.5.3.4CountrySweden
    B.5.4Telephone number8 410 02 887
    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 nameSiplizumab
    D.3.2Product code TCD601
    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 INNSiplizumab
    D.3.9.1CAS number 288392-69-8
    D.3.9.2Current sponsor codeTCD601
    D.3.9.3Other descriptive nameSiplizumab
    D.3.9.4EV Substance CodeSUB33504
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.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 nameSiplizumab
    D.3.2Product code TCD601
    D.3.4Pharmaceutical form Solution 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 INNSiplizumab
    D.3.9.1CAS number 288392-69-8
    D.3.9.3Other descriptive nameSiplizumab
    D.3.9.4EV Substance CodeSUB33504
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    New onset Type I Diabetes
    E.1.1.1Medical condition in easily understood language
    New onset Type I Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 100000004861
    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 effect of 12 weeks of siplizumab treatment on beta-cell function in adults recently diagnosed with T1D compared to placebo at week 52.
    E.2.2Secondary objectives of the trial
    - Assess the incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as compared to placebo.

    - Quantify clinical and laboratory measures of diabetic disease and glycemic indices of siplizumab compared to placebo.

    - Assess the effect of siplizumab on the incidence of local and systemic infections, particularly opportunistic infection.

    - Measure PK and PD activity of siplizumab in subjects with T1D.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand the study requirements and provide written informed consent before any study assessment is performed.
    2. Male or female between 18 to 45 years of age.
    3. A diagnosis of T1D by a qualified healthcare provider based on ADA guidelines (See Appendix 3) ≤ 100 days of randomization.
    4. Positive for at least one diabetes-related autoantibody against:
    o Glutamate decarboxylase (GAD-65),
    o Insulin, if obtained prior and up to 10 days of the onset of exogenous insulin therapy,
    o Insulinoma antigen-2 (IA-2),
    o Zinc transporter-8 (ZnT8), or
    o Islet cell autoantibodies against cytoplasmic proteins in the beta cell (ICA).
    5. Peak stimulated C-peptide level >0.2 pmol/L following a two-hour mixed-meal tolerance test (MMTT) during Screening (Visit 1).
    6. Agreement to follow local, regional, or national guidelines for strict glycemic control with targets of HbA1c ≤ 7.0%.
    7. Agreement to use the same CGM model from screening until the end of the study/Week 52 (see Section 9.10.2).
    8. Up to date immunization status or agreement to receive routine immunizations according to current country and/or regional guidelines and agree to comply with the guidelines for immunosuppressed individuals and those with chronic disease prior to randomization and receipt of study drug.
    E.4Principal exclusion criteria
    1. Inability or unwillingness to provide written informed consent or comply with the study protocol.
    2. History of or suspected intolerance, hypersensitivity, severe reactions, or anaphylaxis to human/humanized monoclonal antibodies or any components of the formulation of siplizumab or its excipients.
    3. History of significant allergy (e.g., anaphylaxis) to milk or soy proteins.
    4. History of recent [within 3 Months of Screening (Visit 1)] or ongoing serious uncontrolled bacterial, viral, fungal, or other opportunistic infections, including:
    • Human immunodeficiency virus (HIV)
    • Current or prior infection with hepatitis B (HBV), as indicated by positive HBsAg or positive HBcAb
    • Current or prior hepatitis C (HCV), unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load (VL) 12 weeks after cessation of therapy)
    • Positive Interferon Gamma Release Assay (IGRA) TB test, e.g., Quantiferon-TB Gold or Quantiferon-TB Gold Plus tests
    • Active infection with EBV as defined by EBV viral load ≥ 10,000 copies per 106 PBMCs or ≥ 2,000 copies per mL of whole blood
    • Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥ 10,000 IU or copies per mL of whole blood or plasma
    5. Any of the following laboratory abnormalities at Screening (Visit 1). Abnormal screening values may be confirmed by a repeat test up to 1 week prior to randomization:
    • White blood count (WBC) < 3 x 109/L
    • Absolute Lymphocyte Count (ALC) < 800 cells/µL
    • Platelet count <150 x 109/L
    • Hemoglobin < 100 g/L
    • ALT ≥ 2x upper limit of normal (ULN)
    • AST ≥ 2x ULN
    6. Current or prior (within 6 months) treatment that is known to alter the natural history of T1D or immunologic status, including high-dose inhaled, extensive topical or systemic glucocorticoids.
    7. Participation in an investigational drug trial within the last six weeks prior to screening.
    8. Current or prior (within 14 days of Visit 1 MMTT) use of any medication known to influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, thiazide, or other potassium-depleting diuretics, β-adrenergic blockers, niacin).
    9. Current or prior (within the last 28 days of Visit 1 MMTT) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.
    10. Previous or current diagnosis of malignancy, except adequately treated cervical carcinoma in situ and adequately treated non-metastatic basal and squamous cell carcinoma.
    11. History of bone marrow transplantation (BMT) / stem cell transplantation or solid organ transplantation.
    12. History or diagnoses of other autoimmune disease, including disease associated with lymphopenia, with the exception of stable thyroid or celiac disease.
    13. History of significant cardiovascular disease (including history of myocardial infarction, angina, use of anti-anginal medicines (e.g., nitroglycerin), or abnormal stress test).
    14. Vaccination with a live attenuated vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette- Guérin, and smallpox) within 28 days of dosing (Day 0).
    15. Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant’s ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study.
    16. Current diagnosed mental illness (e.g., severe depression), current diagnosed or self-reported drug, or alcohol abuse that, in the opinion of the investigator, would interfere with the participant’s ability to comply with study requirements.
    17. Women who are pregnant, lactating, or planning on pregnancy during the study.
    18. Women of child-bearing potential who are unwilling to use a medically acceptable form of contraception until study Week 52. Contraception is required for 14 days prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in mean 4 hour stimulated C-Peptide AUC following a MMTT, compared to placebo at week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    E.5.2Secondary end point(s)
    • Reported AEs/SAEs and AESIs (e.g., local, and systemic infections) graded per CTCAE criteria.
    • Change from baseline in hemoglobin A1c (HbA1c) at weeks 12, 24, 36 and 52.
    • The incidence and severity of hypoglycemic episodes over time (AE, blood glucose).
    • Change from baseline in exogenous insulin usage at weeks 12, 24, 36 and 52.
    • Partial remission as measured by insulin dose adjusted HbA1c (IDAA1c).
    • Change in fasting and postprandial blood glucose concentrations by treatment arm at weeks 12, 24, 36 and 52.
    • The incidence and severity of ketoacidosis.
    • CGM derived Ambulatory Glucose Profiles (AGPs) including mean BG values, Time in Range (TIR), Time Above Range (TAR; High and Very High), Time Below Range (TBR; Low and Very Low) and Glycemic Variability (GV; CV and SD) over time.
    • 4h MMTT C-peptide AUC at weeks 12, 24, and 36.
    • 4h MMTT C-peptide Peak concentration and percent of subjects with ≥0.2 pmol/mL over the course of the study.
    • Incidence, Frequency, and severity of infection AEs/SAEs graded by CTCAE criteria
    • Serial measurement of serum siplizumab concentrations.
    • Serial measurement of total lymphocyte counts, T-cells subsets over time, and siplizumab dose and serum concentrations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    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 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 Yes
    E.8.1.4Double blind No
    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 trial4
    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 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 years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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: 96
    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 state96
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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)
    IMP treatment is 12 weeks, Patient will continue to receive standard of care treatment following study end at Week 52. No additional research or treatment is planned following study end.
    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 Decision2022-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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