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    Summary
    EudraCT Number:2017-005028-11
    Sponsor's Protocol Code Number:I4V-MC-JAIM
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-005028-11
    A.3Full title of the trial
    A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Baricitinib in patients with Lupus
    A.4.1Sponsor's protocol code numberI4V-MC-JAIM
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03843125
    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 SponsorEli Lilly and Company
    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 B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    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 nameBaricitinib
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    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 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.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 B.V, Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
    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 nameBaricitinib
    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.3.9.2Current sponsor codeLY3009104
    D.3.9.3Other descriptive nameBARICITINIB
    D.3.9.4EV Substance CodeSUB31583
    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 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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus ( SLE) also known as Lupus
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and tolerability of baricitinib in patients with SLE.
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD and background standard-of-care therapy on SLE disease activity
    - To evaluate the long-term corticosteroid sparing effect of baricitinib 4-mg or 2-mg QD
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on SLE flares
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on mucocutaneous manifestations of SLE
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on musculoskeletal manifestations of SLE
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on individual organ system disease activity.
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on damage.
    - To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on patient-reported outcomes (PROs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria at
    screening:
    Type of Patient and Disease Characteristics
    [1] Have completed the final treatment study visit of an originating study, such as Study JAHZ or Study JAIA. Patient Characteristics
    [2] Male or nonpregnant, nonbreastfeeding female patient
    a. Patients of child-bearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship
    (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with the opposite sex.
    b. 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, post-ovulation methods, and withdrawal, are not acceptable methods of contraception.
    c. Otherwise, patients of childbearing potential together with their partners 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.
    d. The following contraception methods are considered acceptable (the patient 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:
     Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
     Progestogen-only containing hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
     Intrauterine device (IUD)/intrauterine hormone-releasing system (IUS)
     Vasectomized male (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
     Effective birth control methods:
     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.
     Diaphragm with spermicide
     Cervical sponge
     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.
    Patients of non‒child-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)
     Post-menopausal – defined either as
     A woman at least 50 years of age with an intact uterus, not on hormone therapy, who has had either
     Cessation of menses for at least 1 year
     At least 6 months of spontaneous amenorrhea with follicle- stimulating hormone >40 mIU/mL
     Women aged 55 years or older who are not on hormone therapy, and who have had at least 6 months of spontaneous amenorrhea
     Women aged 55 years or older who have a diagnosis of menopause

    Informed Consent
    [3] Must read and understand the informed consent approved by Eli Lilly and
    Company (Lilly), or its designee, and the institutional review board (IRB)/ethics
    review board (ERB) governing the site, and provide written informed consent.
    E.4Principal exclusion criteria
    [1] Have significant uncontrolled cerebro-cardiovascular (for example, myocardial infarction, unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered.
    [2] Have a known hypersensitivity to baricitinib or any component of this investigational product.
    [3] Had investigational product permanently discontinued at any time during a previous baricitinib study.
    [3] Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the study.
    [4] Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol.
    [5] Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research, judged not to be scientifically or medically compatible with this study.
    E.5 End points
    E.5.1Primary end point(s)
     Proportion of patients with treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs).
     Proportion of patients with temporary investigational product interruptions and permanent discontinuations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 156 time point
    E.5.2Secondary end point(s)
    Proportion of patients achieving SRI-4 response through Week 156, defined as:
    - Reduction of ≥4 points from baseline in SLEDAI-2K score; and
    - No new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity score; and
    - No worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician’s
    Global Assessment of Disease Activity.

    Proportion of patients achieving an SRI-5, -6, -7, or -8 response through Week 156.

    Proportion of patients achieving an LLDAS response through Week 156.

    Change from baseline in mean total SLEDAI-2Kscores through Week 156.

    Change from baseline in Physician’s Global Disease Activity score through Week 156.

    Change from baseline in prednisone dose through Week 156.

    Annualized mild/moderate flare rate

    Annualized severe flare rate

    Annualized flare rate (any severity).

    Proportion of patients with CLASI total activity score ≥ 10 at baseline with ≥50% reduction in CLASI total activity score through Week 156.

    Change from baseline in tender joint count through Week 156.

    Change from baseline in swollen joint count through Week 156.

    Proportion of patients with improvement in each SLEDAI-2K organ system versus baseline through Week 156.

    Proportion of patients with worsening in each SLEDAI-2K organ system versus baseline through Week 156.

    Change from baseline in SLICC/ACR damage index total score through Week 156.

    Change from baseline in Worst Pain NRS through Week 156.

    Change from baseline in Worst Joint Pain NRS through Week 156.

    Change from baseline in Worst Fatigue NRS through Week 156.

    Change from baseline in Patient Global Impression of Severity through Week 156.

    Change from baseline in mental component score (MCS), physical component score (PCS), and domain scores in the Short-Form 36-item health
    survey version 2 (SF- 36v2) acute through Week 156.

    Change from baseline in FACIT-F total score through Week 156.

    Change from baseline in the EQ-5D-5L through Week 156.

    Change from baseline in the WPAI-Lupus through Week 156.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The change will be evaluated from the baseline time point to the study week 156 time point
    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 No
    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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    France
    Germany
    Greece
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Switzerland
    Taiwan
    United Kingdom
    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
    End of the trial is the date of the last visit, last scheduled procedure shown in the Schedule of Activities, or date of discontinued participation for the last patient.
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 990
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 1100
    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 Decision2020-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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