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    Summary
    EudraCT Number:2019-001188-58
    Sponsor's Protocol Code Number:IDIT001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-09-24
    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 number2019-001188-58
    A.3Full title of the trial
    The effect of anti-IL17 in new-onset type 1 diabetes: a randomized, double-blind, placebo-controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of anti-IL17 in new-onset type 1 diabetes: a randomized, double-blind, placebo-controlled trial
    A.3.2Name or abbreviated title of the trial where available
    I-DIT
    A.4.1Sponsor's protocol code numberIDIT001
    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 SponsorGöteborgs Universitet
    B.1.3.4CountrySweden
    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 supportEli Lilly Sweden AB
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportNU Hospital Group
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUniversity of Gothenburg
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVästra Götalandsregionen, NU Hospital Group
    B.5.2Functional name of contact pointNU Hospital Group
    B.5.3 Address:
    B.5.3.1Street AddressNU Hospital Group
    B.5.3.2Town/ cityUddevalla
    B.5.3.3Post code45180
    B.5.3.4CountrySweden
    B.5.6E-mailshilan.seyed.ahmadi@vgregion.se
    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 Taltz
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederländerna BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Suspension for injection in pre-filled injector
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    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 placeboSuspension for injection in pre-filled injector
    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] - Hormonal diseases [C19]
    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
    The primary objective of the study is to examine whether Ixekizumab compared with placebo increases residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile (Mixed Meal Tolerance Test) in newly diagnosed patients with type 1 diabetes.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to examine whether treatment with Ixekizumab compared with placebo leads to change in:

    • Mean Insulin dosage per kilo body weight
    • Time in range (3.9-10 mmol/l) measured by masked CGM
    • Time in hypoglycaemia (<3.9 mmol/l) measured by masked CGM
    • Difference in HbA1c
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for inclusion in the study have to fulfil all of the following criteria:
    • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations before trial activities are begun.
    • Must be willing and capable of taking the study drugs and meet for tests and follow up as described.
    • Diagnosed Type 1 Diabetes (E10.9) within 100 days.
    • First injection of insulin maximum 100 days prior to screening. If age 36-45 years, a current insulin regimen of both basal and prandial insulin or alternately use of an insulin pump should exist.
    • Aged 18-45 years old.
    • Presence of antibodies at clinical practice or at screening to at least one of the following antigens: insulin/IAA, GAD-65, IA-2 and ZnT8.
    • Remaining stimulated peak C–peptide ≥ 0.20 nmol/L. If age 36-45 years, peak C-peptide should be <2.0 nmol/L.
    • Male subjects agree to use a reliable method of birth control during the study.
    • Female subjects:
    Participants of childbearing age or childbearing potential who are sexually active who test negative for pregnancy must be counseled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.

    If the highly effective contraceptive methods are contraindicated or strictly declined by patient, acceptable birth control methods may be considered. These may include combination of both of the following methods:
    o Male or female condom with spermicide
    o Cap, diaphragm, or sponge with spermicide

    1. Highly effective methods of contraception (use 1 form):
    o combined oral contraceptive pill and mini-pill
    o NuvaRing®
    o implantable contraceptives
    o injectable contraceptives (such as Depo-Provera®)
    o intrauterine device (such as Mirena® and ParaGard®)
    o contraceptive patch—ONLY women <198 pounds or 90 kg
    o abstinence from sex
    o vasectomy—for men in clinical studies

    2. Effective methods of contraception (use 2 forms combined)
    o male condom with spermicide
    o female condom with spermicide
    o diaphragm with spermicide
    o cervical sponge
    o cervical cap with spermicide

    Females who are not of childbearing potential include those who have undergone or who have:
    o female sterilization
    o hysterectomy
    o menopause
    o Müllerian agenesis (Mayer–Rokitansky–Küster–Hauser syndrome [also referred to ascongenital absence of the uterus and vagina])

    Females who are not of childbearing potential include those who have undergone or who have:
    o female sterilization
    o hysterectomy
    o menopause
    o Müllerian agenesis (Mayer–Rokitansky–Küster–Hauser syndrome [also referred to ascongenital absence of the uterus and vagina])
    E.4Principal exclusion criteria
    Subjects fulfilling any of the following criteria are not eligible for inclusion in this study:
    • Contraindications to Ixekizumab.
    • Treatment with any oral or injected glucose-lowering agents other than insulin.
    • A history of haemolytic anaemia or significantly abnormal haematology/coagulation results at screening.
    • Participation in other clinical trials with a new chemical entity within the previous 3 months.
    • Subjects with severe obesity (BMI >35 kg/m2 if age 18-35 years and BMI >30 kg/m2 if age 36-45), psoriasis, psoriasis arthritis and axial spondylarthrosis, except celiac disease and hypothyroidism which do not need to be excluded for.
    • Active serious or chronic infections (ie: in case patient had a serious infection (eg pneumonia, cellulitis), has been hospitalized, has received intravenous antibiotics for an infection within 12 weeks prior to screening visit, had a serious bone or joint infection within 24 weeks before screening visit, has ever had an infection of an artificial joint
    • Known immunodeficiency or patient is immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient
    • Active or latent tuberculosis
    • HIV or active hepatitis B or C
    • Active or recurrent fungal infection
    • Subjects with myocardial infarction, stroke, unstable angina or heart failure last 6 months
    • Current clinically significant cardiac arrhythmias as verified by ECG
    • Planned surgery during the treatment period of the study (except minor surgery on skin lesions, e.g., nevus)
    • For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after discontinuation.
    • For male subjects: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness of their partner to use effective contraceptive measures for the duration of the study and 4 months after discontinuation.
    • Any history of malignancy the last 5 years except for completely resected squamous or basal cell carcinoma of the skin.
    • Administration of live attenuated vaccine(s) (LAV) within 2 months of enrolment. Or intended use of LAV during the treatment period.
    • The investigator judges that the clinical diagnosis of T1D set is incorrect or uncertain (needs to be confirmed by discussion with experienced diabetologist if excluding due to this criterion)
    • Allergy against ingredients of the investigational products.
    • Known allergy or hypersensitivity to any biologic therapy (active substance or excipients) that would pose an unacceptable risk to the patient if participating in the study
    • Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study.
    • Liver injury criteria: patients with active hepatobiliary diseases or at screening having alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (>2.5 x ULN)
    • Laboratory abnormalities at screening:
    a. Neutrophil count < 1,500 cells/ μL (=1,5 *109 cells/ L)
    b. Platelet count < 100,000 cells/ μL (= 100 *109 cells/ L)
    c. Hemoglobin < 8.5 g/dL (= <85 g/L) (males) and <8g/dL (= <80 g/L) (women)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) between baseline and week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy variable is difference in change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) from baseline to week 52 between the two treatment groups.
    E.5.2Secondary end point(s)
    The secondary endpoints are the following:
    • Change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52.
    • Change in time with glucose levels in range (3.9-10 mmol/l) measured by masked CGM (Libre Pro) from baseline to week 52
    • Change in time of hypoglycaemia (<3.9 mmol/l) measured by masked CGM (Libre Pro) from baseline to week 52
    • Difference in HbA1c from baseline to week 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary efficacy variables are:
    • Difference in change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52 between the two treatment groups.
    • Difference in change in time in range (3.9-10 mmol/l) from baseline to week 52 measured by masked CGM (Libre Pro) between the two treatment groups.
    • Difference in change in time in hypoglycaemia (<3.9 mmol/l) from baseline to week 52 measured by masked CGM (Libre Pro) between the two treatment groups.
    • Difference in HbA1c from baseline to week 52 between the two treatment groups.
    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 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 concerned19
    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 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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 127
    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 state127
    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)
    No difference from the expected normal treatment of that condition.
    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 Decision2022-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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