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    Summary
    EudraCT Number:2019-000119-10
    Sponsor's Protocol Code Number:I4V-MC-JAHW
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000119-10
    A.3Full title of the trial
    An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis
    Studio in aperto, con controllo attivo, sull’efficacia e la sicurezza di baricitinib somministrato per via orale in pazienti da 2 anni a meno di 18 anni di età con artrite idiopatica giovanile associata ad uveite attiva o con uveite anteriore cronica anticorpi anti-nucleo positivi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Baricitinib in children and young adults with JIA associated eye inflammation
    Studio su Baricitinib in bambini e giovani adulti con artrite idiopatica giovanile associata au un'infiammazione dell'occhio
    A.3.2Name or abbreviated title of the trial where available
    JUVE-BRIGHT
    JUVE-BRIGHT
    A.4.1Sponsor's protocol code numberI4V-MC-JAHW
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/986/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBARICITINIB
    D.3.9.1CAS number 1187594-09-7
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.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 Yes
    D.2.1.1.1Trade name Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBARICITINIB
    D.3.9.1CAS number 1187594-09-7
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 3
    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.2.1.1.1Trade name SUB180983
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNBARICITINIB
    D.3.9.1CAS number 1187594-09-7
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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.IMP: 4
    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 nameOlumiant
    D.3.2Product code [LY3009104]
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNBARICITINIB
    D.3.9.1CAS number 1187594-09-7
    D.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderKG
    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.3.1Product nameHumira
    D.3.2Product code [Humira]
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeADALIMUMAB
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    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.3.1Product nameHumira
    D.3.2Product code [L04AB04]
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeADALIMUMAB
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
    Artrite idiopatica giovanile associata ad uveite o uveite anteriore cronica anticorpi anti-nucleo positiva
    E.1.1.1Medical condition in easily understood language
    Eye inflammation associated with childhood arthritis
    Infiammazione dell'occhio associata ad artrite infantile
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this protocol is to evaluate the efficacy of baricitinib in children with JIA-U or ANA-positive uveitis
    L'obiettivo principale di questo protocollo è valutare l’efficacia di baricitinib somministrato in pazienti pediatrici con artrite idiopatica giovanile associata ad uveite (AIG-U) o con uveite anteriore cronica anticorpi anti-nucleo positivi (ANA)
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to:
    -To evaluate the efficacy of baricitinib in children with JIA-U or ANApositive uveitis in the most severely affected eye and less affected eye.
    -To evaluate the efficacy of adalimumab in children with JIA-U or ANApositive uveitis in the most severely affected eye and less affected eye.
    -To evaluate the safety of baricitinib in children with JIA-U or ANApositive children with JIA-U or ANA-positive uveitis
    Gli obiettivi secondari dello studio sono:
    - valutare l’efficacia di baricitinib somministrato in pazienti pediatrici con AIG-U o con uveite ANA-positiva nell'occhio in condizioni più gravi e nell'occhio in condizioni meno gravi
    - valutare l’efficacia di adalimumab somministrato in pazienti pediatrici con AIG-U o con uveite ANA-positiva nell'occhio in condizioni più gravi e nell'occhio in condizioni meno gravi
    - valutare la sicurezza di baricitinib somministrato in pazienti pediatrici con AIG-U o in pazienti pediatrici ANA-positivi con AIG-U o con uveite ANA-positiva
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Protocol Addendum I4V-MC-JAHW version 1 dated 08-Mar-2019
    An Open-Label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis.
    This addendum allows for the radiographic assessment of paediatric patients with juvenile idiopathic arthritis (JIA)-associated uveitis (JIAU) or chronic anterior antinuclear antibody (ANA)-postive uveitis participating in study I4V-MC-JAHW.
    This addendum is optional. The purpose of the addendum is:
    (1) To assess the effect of baricitinib on changes in bone erosion and joint space narrowing, as observed in hand/ wrist radiographs in a subgroup of patients in study JAHW.
    (2) To assess the effect of baricitinib on bone growth in a subgroup of patients with JIA-U or chronic ANA-positive uveitis via hand/ wrist radiographs.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Protocol Addendum I4V-MC-JAHW versione 1 datato 08-Mar-2019
    Studio in aperto, con controllo attivo, sull’efficacia e la sicurezza di baricitinib somministrato per via orale in pazienti da 2 anni a meno di 18 anni di età con artrite idiopatica giovanile associata ad uveite attiva o con uveite anteriore cronica anticorpi anti-nucleo positivi
    Il presente Addendum prevede la valutazione radiologica dei pazienti pediatrici con artrite idiopatica giovanile associata ad uveite attiva o con uveite anteriore cronica anticorpi anti-nucleo positivi che parteciperanno allo studio I4V-MC-JAHW.
    La partecipazione all'Addendum è opzionale e ha come scopo:
    (1) Valutare gli effetti di baricitinib o le variazioni nell'erosione ossea e negli spazi articolari di congiunzione in base alle osservazioni radiografiche della mano/polso in un sottogruppo di pazienti arruolati nello studio JAHW.
    (2) Valutare gli effetti di baricitinib o l'accrescimento osseo in un sottogruppo di pazienti con AIG-U o con uveite ANA-positiva cronica mediante le radiografie della mano/polso
    E.3Principal inclusion criteria
    [1] Are at least 2 years and less than 18 years of age; full date of birth will be collected except in countries in which it is not allowed.
    [2] Have a diagnosis of JIA U or chronic ANA positive uveitis without systemic features.
    [3] Have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade =1+ at Visit 1 (screening) and Visit 2 (potential randomization), despite prior treatment with adequate doses of topical steroid therapy and MTX.
    [4] Have an inadequate response or intolerance to MTX (minimum dose of 10 mg/m2/week, with a maximum dose of 25 mg/m2/week). Patients considered to have inadequate response must have received MTX for at least 12 weeks before an inadequate response may be determined, and must have been on a stable dose for at least 4 weeks prior to screening if continuing MTX therapy during the study.
    [5] Are receiving topical corticosteroid eye drops at a stable dose for at least 2 weeks prior to screening (maximum of 4 drops/day per eye at screening).
    [6] Both a parent or legal guardian and the patient (as appropriate) are able to understand and fully participate in the activities of the study and sign their consent and assent, respectively, in accordance to local guidelines.
    [7] Male or nonpregnant, nonbreastfeeding female patients. Patients of child-bearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) must agree to remain abstinent.
    Total abstinence is defined as refraining from intercourse during the entirety of the study and for at least 1 week following the last dose of investigational product. Periodic abstinence such as calendar, ovulation, symptothermal, postovulation methods and withdrawal are not
    acceptable methods of contraception. Otherwise, patients and their partners of child bearing potential must agree to use 2 effective methods of contraception, where at least 1 form is highly effective for the entirety of the study and for at least 1 week following the last dose of investigational product. The following contraception methods are considered acceptable (the patient, and their partner, should choose 2, and 1 must be highly effective [defined as less than 1% failure rate per year when used consistently and correctly]):
    • Highly effective birth control methods:
    o Combined (estrogen- and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    o Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or implantable
    o Intrauterine device/intrauterine hormone releasing system
    o Vasectomized partner (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate).
    • Effective birth control methods:
    o Male or female condom with spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined.
    o Diaphragm with spermicide
    o Cervical sponge
    o Cervical cap with spermicide
    Note: When local guidelines concerning highly effective or effective methods of birth control differ from the above, the local guidelines must be followed.
    Adolescent females who have started menses (even 1 cycle and any amount of spotting) are considered to be of child-bearing potential. Women of nonchild-bearing potential are not required to use birth control and they are defined as:
    • Women who are infertile due to surgical sterilization (hysterectomy,bilateral oophorectomy, or tubal ligation) and congenital anomaly such as mullerian agenesis.
    [1] I pazienti hanno almeno 2 anni e meno di 18 anni.
    [2] Avere una diagnosi DI AIG-U o con uveite ANA-positiva senza caratteristiche sistemiche
    [3] Avere una diagnosi di uveite anteriore attiva, definita come infiltrato cellulare nella camera anteriore di grado =1+ secondo il criterio SUN alla Visita 1 (Screening) e alla Visita 2 (potenziale randomizzazione), nonostante un precedente trattamento con dosi adeguate di terapia steroidea topica e MTX.
    [4]Ha una risposta inadeguata o intolleranza agli MTX (dose minima di 10 mg/m2/sett, con una dose massima di 25 mg/m2/sett). I pazienti saranno considerati inadeguatamente responsivi se avranno ricevuto un MTX per almeno 12 settimane prima della risposta inadegata, e devono avere ricevuto una dose stabile per almeno 4 sett prima dello screening (max 4 gocce/die per occhio allo screening)
    [5] Devono assumere un corticosteroideo topico in gocce oculari a una dose stabile per almeno 2 settimane prima dello screening (max 4 gocce/die per occhio allo screening)
    [6] sia uno dei genitori o tutori legali sia il paziente (in base al singolo caso) sono in grado di comprendere e partecipare attivamente a tutte le attività e firmare rispettivamente il consenso e l'assenso, in conformtà alla normativa locale.
    [7]Pazienti di sesso maschile o donne non gravide, che non stiano allattando. I pazienti in età fertile che si astengono dall'attività sessuale (se è astinenza completa, come si addice sl loro stile di vita preferito e abituale) devono accettare di rimanere astinenti.
    L'astinenza totale è definita come astenersi dal rapporto sessuale durante l'intera durata dello studio e per almeno 1 settimana dall'ultima dose di prodotto sperimentale. L'astinenza periodica come metodi basati sui giorni del calendario, l'ovulazione, sintotermici, postovulazione e l'interruzione dell'atto non sono metodi contraccettivi accettabili. In caso contrario, i pazienti e i loro partner in età fertile devono concordare l'uso di 2 metodi contraccettivi efficaci, di cui almeno 1 forma è altamente efficace per l'intero studio e per almeno 1 settimana dopo l'ultima dose del prodotto sperimentale. I seguenti metodi di contraccezione sono considerati accettabili (il paziente e il suo partner dovrebbero sceglierne 2 e 1 deve essere altamente efficace [definito come tasso di insuccesso inferiore all'1% all'anno se usato in modo coerente e corretto]):
    • Metodi di controllo delle nascite altamente efficaci:
    Contraccezione ormonale combinata (contenente estrogeni e progestinici) associata a inibizione dell'ovulazione: orale, intravaginale o transdermica
    o Contraccezione ormonale da progestinico associata a inibizione dell'ovulazione: orale, intravaginale o impiantabile
    o Dispositivo intrauterino / sistema di rilascio di ormone intrauterino
    o Partner vasectomizzato (con appropriata documentazione post vasectomia sull'assenza di spermatozoi nell'eiaculato).
    • Metodi efficaci di controllo delle nascite:
    o Preservativo maschile o femminile con spermicida. Va notato che l'uso di preservativi maschili e femminili come metodo a doppia barriera non è considerato accettabile a causa dell'elevato tasso di fallimento quando questi metodi sono combinati.
    o Diaframma con spermicida
    o spugna cervicale
    o Cappuccio cervicale con spermicida
    Nota: quando le linee guida locali riguardanti metodi di controllo delle nascite altamente efficaci o efficaci differiscono da quanto sopra, le linee guida locali devono essere seguite.
    Le femmine adolescenti che hanno iniziato le mestruazioni (anche 1 ciclo e qualsiasi quantità di spotting) sono considerate potenzialmente fertili. Alle donne non sposate non è richiesto di usare il controllo delle nascite e sono definite come:
    • Donne sterili per sterilizzazione chirurgica (isterectomia, ooforectomia bilaterale o legatura delle tube) e anomalie congenite come l'agenesia mulleriana.
    E.4Principal exclusion criteria
    [8] Have uveitis without a diagnosis of JIA or chronic anterior uveitis without positive ANA. [9] Have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis. [10] Have any contraindications to adalimumab as addressed in local product labeling or local clinical practice that would preclude the patient from participating in this study. Exception: Patients who are bDMARD IR with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib. [11] Have increased intraocular pressure =25 mm Hg or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study.
    [12] Have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy). [13] Are pregnant or breastfeeding. Prior to initiation of treatment, female patients of child-bearing potential must have a negative serum pregnancy test at the central laboratory during screening and a negative urine pregnancy test at Visit 2. [14] Have a current or recent (<4 weeks prior to baseline) clinically serious viral, bacterial, fungal, or parasitic infection or any other active or recent infection that, in the opinion of the investigator, would pose an unacceptable risk to the patient if participating in the study. [15] Have had an infection of bone or joint within 6 months prior to screening. [16] Have symptomatic herpes simplex at baseline. [17] Have had symptomatic herpes zoster infection within 12 weeks prior to baseline. [18] Have a history of multidermatomal herpes zoster, or complicated herpes zoster (e.g., ocular or motor nerve involvement or disseminated herpes zoster such as systemic infection). [19] Have a positive test for hepatitis B virus (HBV) at screening defined as: a. positive for hepatitis B surface antigen (HBsAg), or b. positive for hepatitis B core antibody (HBcAb) and positive for HBV deoxyribonucleic acid (DNA) [20] Have hepatitis C virus (HCV) infection (hepatitis C antibody positive and confirmed presence of HCV ribonucleic acid [RNA]). [21] Have evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies. [22] Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB. [23] Have evidence of active TB or
    untreated/inadequately/inappropriately treated latent TB a. Have evidence of active TB, [24] Had major surgery within 8 weeks prior to screening or will
    require major surgery during the study that in the opinion of the investigator in consultation with Lilly or its designee would pose an unacceptable risk to the patient. [25] Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. [26] Have a history of a VTE or are considered at high risk of VTE as deemed by the investigator. [27] Are largely or wholly incapacitated, such as being bedridden.
    8] Avere uveite senza una diagnosi di JIA o uveite anteriore cronica senza ANA positivi. [9] Hanno una storia o presenza di qualsiasi condizione infiammatoria autoimmune diversa da AIG, come la malattia di Crohn o la colite ulcerosa. [10] Avere controindicazioni ad adalimumab come indicato nel foglio illustrativo del prodotto locale o dalla pratica clinica locale che preclude al paziente la partecipazione a questo studio. Eccetto: I pazienti che sono bDMARD IR con una controindicazione ad adalimumab possono essere arruolati, in quanto verranno assegnati a baricitinib. [11] Hanno un innalzamento della pressione intraoculare =25 mm Hg o quel trattamento richiesto, inclusi aumenti di farmaci, interventi chirurgici o ospedalizzazione, entro 4 settimane prima del basale che, secondo il parere dello sperimentatore, comporterebbero un rischio inaccettabile per il paziente se partecipare allo studio. [12] Hanno avuto un intervento chirurgico intraoculare entro i 3 mesi precedenti allo screening (come per la cataratta (s), il glaucoma o la vitrectomia). [13] Sono incinta o allattano al seno. Prima dell'inizio del trattamento, le pazienti di sesso femminile in età fertile devono presentare un test di gravidanza sierica negativo presso il laboratorio centrale durante lo screening e un test di gravidanza negativo alle urine alla Visita 2.[14] Hanno una infezione virale, batterica, fungina o parassitaria clinicamente grave o recente o precedente o qualsiasi altra infezione attiva o recente che, secondo il parere dello sperimentatore, comporterebbe un rischio inaccettabile per il paziente se partecipante allo studio. [15] Ha avuto un'infezione da osso o articolazione entro 6 mesi prima dello screening. [16] Ha herpes simplex sintomatico al basale. [17] Ha avuto un'infezione da herpes zoster sintomatica entro 12 settimane prima del basale. [18] Hanno una storia di herpes zoster multidermatomale, o herpes zoster complicato (ad es. Coinvolgimento di nervi oculari o motori o herpes zoster disseminato come infezione sistemica). [19] Avere un test positivo per il virus dell'epatite B (HBV) allo screening definito come: a. positivo per l'antigene di superficie dell'epatite B (HBsAg), o b. positivo per anticorpi anti-epatite B (HBcAb) e positivi per acido desossiribonucleico HBV (DNA) [20] Ha un'infezione da virus dell'epatite C (HCV) (presenza di anticorpi positivi per l'epatite C e confermata presenza di acido ribonucleico HCV [RNA]). [21] Avere evidenza di infezione da virus dell'immunodeficienza umana (HIV) e / o anticorpi HIV positivi. [22] Hanno avuto contatti familiari con una persona con tubercolosi attiva (TB) e non hanno ricevuto profilassi appropriata e documentata per la tubercolosi. [23] Avere evidenza di TB attiva o TB latente non trattata / inadeguatamente / inadeguatamente trattata a. Avere evidenza di TB attiva, [24] Ha avuto un intervento chirurgico maggiore entro 8 settimane prima dello screening o richiederà un intervento chirurgico maggiore durante lo studio che secondo il parere dello sperimentatore in consultazione con Lilly o il suo designato rappresenterebbe un rischio inaccettabile per il paziente. [25] Hanno una storia o presenza di disturbi cardiovascolari, respiratori, epatici, gastrointestinali, endocrini, ematologici, neurologici o neuropsichiatrici o qualsiasi altra malattia grave e / o instabile che, secondo il parere dello sperimentatore, potrebbe costituire un inaccettabile rischio durante l'assunzione di prodotti sperimentali o interferire con l'interpretazione dei dati.
    [26] Hanno una storia di VTE o sono considerati ad alto rischio di TEV come ritenuto dall'investigatore.
    [27] Sono in gran parte o del tutto inabili, come essere costretti a letto.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of responders at Week 24. Response is defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.
    L'endpoint primario è la percentuale di responder alla settimana 24. La risposta è definita secondo i criteri di normalizzazione della Uveite Nomenclatura (SUN) come diminuzione in 2 fasi del livello di infiammazione (cellule della camera anteriore) o diminuzione fino a zero durante la settimana 24, negli occhi più gravemente colpiti al basale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 24
    Alla Settimana 24
    E.5.2Secondary end point(s)
    -Change in SUN grade of cells in the anterior chamber through Week 24 in the most severely affected eye.
    - Change in SUN grade of cells in the anterior chamber through week 24 in the less severely affected eye.
    -Change in visual acuity by age-appropriate assessments through week 24.
    -Change in vitreous haze through week 24.
    -Change in grade of flare in the anterior chamber through week 24.
    -Change in overall uveitis-related disability (assessment by parent and child VAS) through week 24.
    -Proportion of patients with inactive anterior uveitis disease (using SUN definition) through Week 24.
    -Time to inactive anterior disease (using SUN definition).
    -Adverse events including serious adverse events.
    -Change in SUN grade of cells in the anterior chamber through week 284 in the most severely affected eye.
    -Change in SUN grade of cells in the anterior chamber through week 284 in the less severely affected eye.
    -Change in visual acuity by age-appropriate assessments through week 284.
    -Change in vitreous haze through Week 284.
    -Change in grade of flare in the anterior chamber through week 284.
    -Change in overall uveitis-related disability through week 284.
    -Cambiamento del grado SUN delle cellule nella camera anteriore fino alla settimana 24 nell'occhio più gravemente colpito.
    - Cambiamento del grado SUN delle cellule nella camera anteriore fino alla settimana 24 nell'occhio meno gravemente colpito.
    -Cambia l'acutezza visiva con valutazioni adeguate all'età fino alla settimana 24.
    -Cambiamento della foschia vetrosa attraverso la settimana 24.
    -Cambiamento del grado di riacutizzazione nella camera anteriore fino alla settimana 24.
    -Cambiamento dell'invalidità generale correlata all'uveite (valutazione da parte dei genitori e dei bambini VAS) fino alla settimana 24.
    -Proporzione dei pazienti con malattia uveitica anteriore inattiva (utilizzando la definizione SUN) fino alla settimana 24.
    -Tempo di malattia anteriore inattiva (utilizzando la definizione SUN).
    - Eventi avversi inclusi eventi avversi gravi.
    -Cambiamento del grado SUN delle cellule nella camera anteriore fino alla settimana 284 nell'occhio più gravemente colpito.
    -Cambiamento del grado SUN delle cellule nella camera anteriore fino alla settimana 284 nell'occhio meno gravemente colpito.
    -Cambia l'acutezza visiva con valutazioni adeguate all'età fino alla settimana 284.
    -Cambiamento della foschia vetrosa attraverso la settimana 284.
    -Cambiamento del grado di riacutizzazione nella camera anteriore fino alla settimana 284.
    -Cambiamento dell'invalidità generale correlata all'uveite fino alla settimana 284.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 and Week 284
    Settimana 24 e Settimana 284
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 17
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients from 2 to 18 years old
    Pazienti da 2 a 18 anni di età
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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)
    Following conclusion of this study, patients will be referred to their local treatment centers for therapy as clinically indicated. An interim analysis and study report will occur following week 24 completion by all patients. If after the conclusion of the study, baricitinib is approved,
    patients enrolled in this study may be able to transition to commericial Olumiant.
    Dopo la conclusione di questo studio, i pazienti saranno indirizzati ai loro centri di trattamento locali per la terapia come clinicamente indicato. Un'analisi interim e un report dello studio saranno eseguiti dopo il completamento della settimana 24 da parte di tutti i pazienti. Se dopo la conclusione dello studio baricitinib è approvato, i pazienti arruolati in questo studio potrebbero passare a Olumiant commerciale.
    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 Ancillare
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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