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    Summary
    EudraCT Number:2018-000659-42
    Sponsor's Protocol Code Number:TN-22
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-22
    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 ConcernedFinland - Fimea
    A.2EudraCT number2018-000659-42
    A.3Full title of the trial
    HYDROXYCHLOROQUINE FOR PREVENTION OF ABNORMAL GLUCOSE
    TOLERANCE AND DIABETES IN INDIVIDUALS AT-RISK FOR TYPE 1
    DIABETES MELLITUS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CHLOROQUINE FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE
    AND DIABETES IN INDIVIDUALS AT-RISK FOR TYPE 1 DIABETES
    MELLITUS
    A.4.1Sponsor's protocol code numberTN-22
    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 SponsorTrialNet Coordinating Center
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrialNet Coordinating Center
    B.5.2Functional name of contact pointCourtney Henderson
    B.5.3 Address:
    B.5.3.1Street Address3650 Spectrum Boulevard, Suite 100
    B.5.3.2Town/ cityTampa, Florida
    B.5.3.3Post code33612
    B.5.3.4CountryUnited States
    B.5.4Telephone number1813396 9183
    B.5.6E-mailCourtney.Henderson@epi.usf.edu
    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 Yes
    D.2.1.1.1Trade name Hydroxychloroquine Sulfate 200mg tablet Sandoz, Inc. NDC # 0781-5994-01
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameHYDROXYCHLOROQUINE SULPHATE
    D.3.2Product code P01BA02
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    individuals at-risk for type 1 diabetes mellitus (T1D)
    E.1.1.1Medical condition in easily understood language
    T1D is an immune disease in which the cells wich produce insulin are completely or almost completely destroyed by your oun immune system, resulting in life-long dependence on exogenous insulin.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    To assess the efficacy, safety and mode of action of hydroxychloroquine to prevent progression from Stage 1 to Stage 2 or Stage 3 of T1D. The primary objective is to determine whether intervention with hydroxychloroquine will prevent or delay the progression from Stage 1 (normal glucose tolerance) to Stage 2 (abnormal glucose tolerance) or Stage 3 (clinically overt T1D).
    E.2.2Secondary objectives of the trial
    Secondary outcomes include: the effect of hydroxychloroquine on the risk of T1D; analyses of metabolic and immune changes over time; safety and tolerability; evaluation of other possible factors on effect (association and effect modification); and mechanistic outcomes.Please enter information in English and add any other language that is applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A participant in TrialNet Pathway to Prevention Study (TN01).

    2. Age ≥ 3 years at the time of randomization in this trial.

    3. Willing to provide informed consent or, if the participant is <18 years of age, have a parent or legal guardian provide informed consent.

    4. Normal glucose tolerance by OGTT within 7 weeks (no more than 52 days) prior to baseline (Visit 0). If previous abnormal glucose tolerance, has had two consecutive OGTTs with normal glucose tolerance:
    a. Fasting plasma glucose < 110 mg/dL (6.1 mmol/L), and
    b. 2 hour plasma glucose <140 mg/dL (7.8 mmol/L), and
    c. 30, 60, or 90 minute value on OGTT< 200mg/dL (11.1 mmol/L).

    5. Two or more diabetes-related autoantibodies present on two separate samples, one of which was drawn within the past six months (210 days). Confirmation does not have to involve the same 2 autoantibodies.

    6. Weight ≥ 12 kg at the time of screening.

    7. If a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit.

    8. Anticipated ability to swallow study medication
    E.4Principal exclusion criteria
    1. Abnormal Glucose Tolerance or Diabetes
    a. Fasting plasma glucose ≥ 110 mg/dL (6.1 mmol/L), or
    b. 2 hour plasma glucose ≥ 140 mg/dL (7.8 mmol/L), or
    c. 30, 60, 90 minute plasma glucose during OGTT ≥ 200 mg/dL (11.1 mmol/L)

    2. History of treatment with insulin or other diabetes therapies.

    3. Ongoing use of medications known to influence glucose tolerance, e.g. glucocorticoids, growth hormone, anticonvulsants, thiazide or potassium-depleting diuretics, beta adrenergic blockers, niacin and antipsychotics. Participants on such medications should be changed to a suitable alternative, if available, by their primary care provider, and will become eligible one month after medication is discontinued.

    4. Ongoing or anticipated future use of any medications known to impact T1D progression or have untoward interactions with hydroxychloroquine.

    5. Known hypersensitivity to 4-aminoquinoline compounds.

    6. G6PD deficiency.

    7. History of retinopathy.

    8. Active infection at time of randomization.

    9. Serologic evidence of current or past HIV, Hepatitis B (positive for Hepatitis B core antibody or surface antigen), or Hepatitis C infection.

    10. Deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged QT interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the elapsed time from random treatment assignment to the development of confirmed abnormal glucose tolerance or clinical diabetes among those enrolled in the primary analysis cohort consisting of participants with islet cell autoimmunity and absence of metabolic abnormalities (normal OGTT).The date of the confirmatory abnormal OGTT or diabetes will be considered as the date of reaching these study endpoints. It is expected that abnormal glucose tolerance will be detected prior to diabetes onset by OGTT; however, the presence of diabetes, without a previous abnormal OGTT, is also considered an endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The study endpoint will be evaluated for every 6 months via oral glucose tolerance tests. Participants who have progressed to Stage 2 T1D by virtue of having developed confirmed abnormal glucose tolerance will have reached the primary study endpoint
    E.5.2Secondary end point(s)
    These participants who have developed abnormal glucose tolerance but have not progressed to Stage 3 T1D (clinical onset) will have the option to remain in this study without further therapy, undergoing close monitoring and safety assessments until the development of Stage 3 T1D (clinically overt diabetes) or until they enroll in another clinical trial, whichever comes first.Once participants reach Stage 3 (diagnosis of clinical diabetes), they will no longer be followed in the context of this protocol; however, they will be offered follow-up in the Long Term Investigative Follow- Up in TrialNet (LIFT) Study (TN16). Alternatively, individuals who progress to Stage 3 may be eligible for interventional studies sponsored by TrialNet or other organizations under separate INDs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The study endpoint will be evaluated for every 6 months via oral glucose tolerance tests
    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 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 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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Canada
    New Zealand
    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 or until participants will develop study endpoints
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    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: 190
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 119
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 71
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 11
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 201
    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 Decision2019-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-11
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