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    Summary
    EudraCT Number:2018-002918-12
    Sponsor's Protocol Code Number:CC-10004-PPSO-003
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-17
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2018-002918-12
    A.3Full title of the trial
    A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Apremilast (CC-10004) in Pediatric Subjects from 6 through 17 Years of Age with Moderate to Severe Plaque Psoriasis
    Fáze 3 multicentrického, randomizovaného, dvojitě zaslepeného, placebem kontrolovaného klinického hodnocení k posouzení účinnosti a bezpečnosti apremilastu (CC-10004) u pediatrických pacientů ve věku od 6 do 17 let se středně těžkou až těžkou plakovou psoriázou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Apremilast in Children 6 through 17 Years with Moderate to Severe Plaque Psoriasis
    A.3.2Name or abbreviated title of the trial where available
    SPROUT
    A.4.1Sponsor's protocol code numberCC-10004-PPSO-003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03701763
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1219-3112
    A.5.4Other Identifiers
    Name:INDNumber:070270
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/163/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen Inc.
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressSuurstoffi 22
    B.5.3.2Town/ cityRotkreuz
    B.5.3.3Post codeCH-6343
    B.5.3.4CountrySwitzerland
    B.5.6E-mailmedinfointernational@amgen.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 Otezla (apremilast)
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameApremilast 10 mg
    D.3.2Product code CC-10004
    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 INNApremilast 10 mg
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Otezla (apremilast)
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameApremilast 20 mg
    D.3.2Product code CC-10004
    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 INNApremilast 20 mg
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    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 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: 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 Yes
    D.2.1.1.1Trade name Otezla (apremilast)
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameApremilast 30 mg
    D.3.2Product code CC-10004
    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 INNApremilast 30 mg
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.9.3Other descriptive nameAPREMILAST
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 3
    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
    Plaque Psoriasis
    E.1.1.1Medical condition in easily understood language
    Scaly skin rash
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    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 evaluate the clinical efficacy of apremilast compared with placebo in children and adolescents (ages 6
    through 17 years) with moderate to severe plaque psoriasis.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •To evaluate the safety and tolerability of apremilast compared with placebo, in children and adolescents (ages 6 through 17 years) with
    moderate to severe plaque psoriasis
    •To evaluate the effect of apremilast compared with placebo on health-related quality of life (HRQoL)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacodynamic Peripheral Blood RNA Gene Expression Analysis Sub-Study:
    Type: pharmacodynamics.
    Objective of this sub-study is analysis of specific RNAs to define the mechanism of action of apremilast in patient study population. Data may also inform on the subset of patients who are responding well to
    apremilast treatment.
    version and date of protocol final 15 August 2018

    Pharmacogenetic DNA Analysis Sub-Study:
    Type: pharmacogenetics.
    The objective of this sub-study is to analyze the genetic polymorphisms that are associated with clinical and pharmacodynamic interaction with apremilast.
    version and date of protocol final 15 August 2018

    Skin Microbiome Analysis Sub-Study:
    Type: other - Skin Microbiome Analysis
    The objective of this sub-study is to assess the microbial species (bacterial and fungal) present on the patients' skin by swabbing the affected and unaffected skin and subjected the swabbed material to 16S
    and ITS ribosomal RNA gene amplification and sequencing.
    version and date of protocol final 15 August 2018
    E.3Principal inclusion criteria
    Subject must satisfy the following criteria to be enrolled in the study:
    1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
    2. Subjects must have a weight of ≥ 20 kg
    3. Subject must have age and sex-specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.
    4. Subject is able to swallow the study medication tablet
    5. Able to sign an age-appropriate assent with a legal guardian(s) who understand(s) and voluntarily sign(s) an informed consent prior to any study-related assessments/procedures being conducted.
    6. Be willing and able to adhere to the study visit schedule and other protocol requirements.
    7. Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening.
    8. Has moderate to severe plaque psoriasis at screening and baseline as defined by:
    • PASI score ≥ 12; and
    • Body surface area (BSA) ≥ 10%; and
    • sPGA ≥ 3 (moderate to severe)
    9. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis.
    10. Candidate for systemic therapy or phototherapy.
    11. At screening, laboratory values must be within the following ranges
    •White blood cell (WBC) count
    Age (years) Males (x 103 /µL) Females (x 103 /µL)
    6-11 3.5 – 13.5 3.5 – 13.5
    12-18 3.5 – 13.5 3.5 – 13.5

    •Platelet count
    Age (years) Males (x 103 /µL) Females (x 103 /µL)
    6-11 125 – 500 125 – 500
    12-18 125 – 500 125 – 500

    •Serum creatinine ≤ 1.2 x upper-limit of normal (ULN) for age and gender. Please see reference ranges of the central laboratory
    •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 1.5 x ULN for age and gender. If initial test of ALT or AST is > 1.5 x ULN, one repeat test is allowed during Screening. Please see the reference ranges of the central laboratory
    •Total bilirubin ≤ 2 mg/dL (≤ 34 µmol/L). If initial test result is > 2 mg/dL, one repeat test is allowed during the Screening period
    •Hemoglobin (Hb)
    Age (years) Males (g/dL) Females (g/dL)
    6-11 10.0 – 15.0 10.0 – 15.0
    12-18 11.0 – 16.5 10.5 – 15.5

    12. All females of childbearing potential (FCBP) must either practice abstinence* from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and
    during any dose interruption, and for at least 28 days after administration of the last dose of apremilast. For the purpose of thisstudy, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first.

    At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.

    Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive+ options described below:
    Option 1: Any one of the following highly effective methods: hormonal contraception (for example, birth control pills, intravaginal ring, transdermal patch, injection, implant); intrauterine device (IUD); tubal ligation; or partner's vasectomy.
    OR
    Option 2: Male or female latex condom or nonlatex condom NOT made out of natural (animal) membrane (for example, polyurethane); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.

    NOTE: Option 2 may not be acceptable as a highly effective contraception option in all countries per local guidelines/regulations.

    * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

    + If a female subject is a FCBP when entering the study, the chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from
    enrollment:
    1. Other than psoriasis, history of any clinically significant (as
    determined by the Investigator) cardiac, endocrinologic, pulmonary,
    neurologic, psychiatric, hepatic, renal, hematologic, immunologic
    disease, or other major uncontrolled disease.
    2. Any condition, including the presence of laboratory abnormalities,
    or psychiatric illness, that would place the subject at unacceptable risk
    if he/she were to participate in the study
    3. Any condition that confounds the ability to interpret data from the
    study.
    4. Evidence of skin conditions, other than psoriasis, that would
    interfere with clinical assessments
    5. Pregnant or breastfeeding
    6. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
    7. Psoriasis flare or rebound within 4 weeks prior to Screening
    8. Positive Hepatitis B surface antigen, or anti-hepatitis C antibody, at Screening
    9. History of positive human immunodeficiency virus infection (HIV),
    congenital and acquired immunodeficiencies (eg, common variable
    immunodeficiency, immunoglobulin A deficiency)
    10. Active tuberculosis (TB) or a history of incompletely treated TB
    11. History of recurrent significant infections
    12. Active infection or infection treated with antibiotic treatment within 2 weeks of first dose
    13. Any history of or active malignancy
    14. History of allergy/intolerance to any component of the
    investigational product, ie, apremilast, lactose monohydrate,
    microcrystalline cellulose, croscarmellose sodium, magnesium stearate,
    hypromellose 15cP, titanium dioxide, polydextrose food chemical color,
    talc, maltodextrine, medium chain triglycerides, iron oxide red, iron
    oxide yellow, and iron oxide black.
    15. Deficiencies in lactose metabolism, ie, galactose-1-phosphate
    uridylyltransferase, UDP-galactose 4-epimerase, galactokinase or
    Fanconi Bickel syndrome, including congenital lactase deficiencies, and
    glucose-galactose malabsorption.
    16. Prior history of suicide attempt at any time in the subject's
    lifetime prior to Screening or randomization in the study, or major
    psychiatric illness requiring hospitalization within 3 years prior to
    signing the assent and informed consent
    17. Answer "Yes" to any question on the Columbia-Suicide Severity
    Rating Scale during Screening or at Baseline
    18. Current or planned concurrent use of the following therapies that
    may have a possible effect on psoriasis
    a. Topical therapy within 2 weeks prior to randomization (including
    but not limited to topical corticosteroids, topical retinoid or vitamin D
    analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)
    Exceptions*:
    i. Low potency or weak corticosteroids (please refer to the
    Investigators' Manual) will be allowed as background therapy for
    treatment of the face, axillae and groin in accordance with
    manufacturer's suggested usage
    ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted
    for body lesions
    *Subjects should not use these topical treatments within 24 hours prior
    to the clinic visit.
    b. Conventional systemic therapy for psoriasis within 4 weeks prior to
    randomization (including but not limited to cyclosporine,
    corticosteroids, methotrexate, oral retinoids, mycophenolate,
    thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)
    c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4
    weeks prior to randomization
    d. Biologic therapy:
    i. Etanercept (or biosimilar) treatment four weeks prior to randomization
    ii. Adalimumab (or biosimilar) treatment ten weeks prior to randomization
    iii. Other TNF or IL-17 blockers (such as infliximab, certolizumab
    pegol, secukinumab, ixekizumab, brodalumab, or their biosimilars) within 12 weeks prior to randomization
    iv. Anti-IL-12 or anti-IL-23 treatment (such as ustekinumab,
    guselkumab, or tildrakizumab) within 24 weeks prior to randomization
    e. Use of any investigational drug within 4 weeks prior to
    randomization, or 5 pharmacokinetic/pharmacodynamic half-lives, if
    known (whichever is longer)
    19. Prolonged sun exposure or use of tanning booths or other
    ultraviolet (UV) light sources
    20. Children in Care: a child who has been placed under the control or
    protection of an agency, organization, institution or entity by the
    courts, the government or a government body, acting in accordance
    with powers conferred on them by law or regulation
    21. Prior treatment with apremilast
    E.5 End points
    E.5.1Primary end point(s)
    Static Physician Global Assessment (sPGA) - Proportion of subjects
    with an sPGA score of clear (0) or almost clear (1) with at least a 2-
    point reduction from baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be evaluated at the end of Week 16.
    E.5.2Secondary end point(s)
    1. Psoriasis Area Severity Index-75 (PASI-75) - Proportion of subjects
    who achieve at least a 75% reduction in PASI (PASI-75) from baseline
    2. PASI-50 - Proportion of subjects who achieve at least a 75% reduction
    in PASI (PASI-75) from baseline
    3. PASI - Percent change from baseline in total PASI score
    4. Children's Dermatological Life Quality Index (CDLQI) - Change from
    baseline in CDLQI score
    5. CDLQI (0/1) - Proportion of subjects who achieve CDLQI (0/1)
    6. Body Surface Area (BSA) - Percent change from baseline in affected BSA
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at the end of Week 16.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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) 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 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 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 EEA50
    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
    Canada
    Israel
    Russian Federation
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Italy
    Netherlands
    Spain
    Switzerland
    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
    The End of Trial is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for efficacy and/or safety assessments, as pre-specified in the protocol, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days14
    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: 230
    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: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 155
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 230
    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)
    All eligible subjects who complete the apremilast Extension Phase may
    opt to enroll in a separate Long-term Study (for up to 4 years or until
    approval, whichever comes first). Subjects who choose not to
    participate in the Long-term Study, or discontinue the study early,
    should return for observational follow-up visits four, eight, and
    fourteen weeks after the last dose of IP.
    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 Decision2019-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-27
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