Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7337   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002918-12
    Sponsor's Protocol Code Number:CC-10004-PPSO-003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    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
    Studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di Apremilast (CC-10004) in soggetti pediatrici di età compresa tra 6 e 17 anni con psoriasi a placche da moderata a grave
    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
    Sicurezza ed efficacia di Apremilast nei bambini di età compresa tra 6 e 17 anni con psoriasi a placche da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    SPROUT
    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 SponsorCELGENE CORPORATION
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18882601599
    B.5.5Fax number+19132660394
    B.5.6E-mailClinicaltrialdisclosure@celgene.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 holderCelgene Corporation 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 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 Otezla (apremilast)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene 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 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 Yes
    D.2.1.1.1Trade name Otezla (apremilast)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Corporation 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 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
    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
    Psoriasi a placche
    E.1.1.1Medical condition in easily understood language
    Scaly skin rash
    eruzione cutanea squamosa
    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.
    L'obiettivo primario dello studio è valutare l'efficacia clinica di apremilast rispetto al placebo nei bambini e negli adolescenti (età compresa tra 6 e 17 anni) affetti da psoriasi a placche da moderata a grave.
    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 healthrelated
    quality of life (HRQoL)
    Gli obiettivi secondari sono:
    •Valutare la sicurezza e la tollerabilità di apremilast rispetto al placebo nei bambini e negli adolescenti (età compresa tra 6 e 17 anni) affetti da psoriasi a placche da moderata a grave
    •Valutare l’effetto di apremilast rispetto al placebo sulla qualità della vita correlata allo stato di salute (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

    Pharmacogenetics
    Version: protocollo finale
    Date: 15/08/2018
    Title: Pharmacogenetic DNA Analysis Sub-Study
    Objectives: The objective of this sub-study is to analyze the genetic polymorphisms that are associated with clinical and pharmacodynamic interaction with apremilast.

    Other types of substudies
    Specify title, date and version of each substudy with relative 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

    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

    Farmacogenetica
    Versione: protocollo finale
    Data: 15/08/2018
    Titolo: Sottostudio di farmacogenetica per l’analisi del DNA
    Obiettivi: L’obiettivo del presente sottostudio è analizzare i polimorfismi genetici associati alle interazioni cliniche e farmacodinamiche con apremilast.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di farmacodinamica per l’analisi dell’espressione genica mediata dall’RNA nel sangue periferico:
    Tipo: farmacodinamica.
    L’obiettivo del presente sottostudio è l’analisi di specifici RNA per definire il meccanismo di azione di apremilast nella popolazione di pazienti dello studio. I dati possono
    inoltre fornire informazioni utili per il sottogruppo di pazienti che risponde bene al trattamento con apremilast.
    versione e data del protocollo finale 15 agosto 2018

    Sottostudio di analisi del microbioma cutaneo:
    Tipo: altro – Analisi del microbioma cutaneo
    L’obiettivo del presente sottostudio è valutare le specie microbiche (batterica e fungina) presenti sulla cute dei pazienti mediante tampone della cute interessata e non interessata e sottoponendo il materiale su tampone all’amplificazione e al sequenziamento dell’RNA ribosomiale per i geni 16S e ITS.
    versione e data del protocollo finale 15 agosto 2018
    E.3Principal inclusion criteria
    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 this
    study, 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.
    1. sesso M o F da 6 a 17 anni di età, compresi, alla firma firma del modulo di CI da parte del tutore legale; 2. I soggetti devono pesare almeno > = 20 kg 3.I soggetti devono presentare un indice di massa corporea (IMC) specifico per età e sesso non inferiore al 5° percentile riportato nella tabella di crescita dei Centri per il controllo delle malattie (Centers for Disease Control, CDC) per bambini e adolescenti (CDC, 2000). 4. Il soggetto è in grado di ingerire le compresse di farmaco in studio; 5. Fare riferimento al protocollo di studio. 6. Intendere ed essere in grado di attenersi al programma di visite dello studio e agli altri requisiti del prot. 7. Diagnosi di psoriasi cronica a placche per almeno 6 mesi prima dello screening.
    8. fare riferimento al protocollo di studio 9. Fare riferimento al protocollo di studio 10. Candidato alla terapia sistemica o fototerapia
    11. Allo screening, i valori di laboratorio devono essere entro i seguenti intervalli: •Conta dei globuli bianchi (WBC): Età (anni) M (x 103/µl) F (x 103/µl) 6-11 3.5 – 13.5 3.5 – 13.5; 12-18 3.5 – 13.5 3.5 – 13.5 ; • Conta piastrinica Età (anni) M (x 103/µl) F (x 103/µl) 6-11 125 – 500 125 – 500; 12-18 125 – 500 125 – 500
    • Creatinina nel siero <= 1,2 volte il limite superiore della norma (ULN) per età e sesso. vedi intervalli di riferimento del lab centrale
    • AST [SGOT] e ALT [SGPT] < = 1,5 x ULN per età e sesso. Se dal test iniziale emerge un valore ALT o AST > 1,5 x ULN, è consentita una ripetizione del test durante lo screening. vedi intervalli di riferimento del lab centrale
    • Bilirubina totale <= 2 mg/dl (= 34 µmol/l). Se dal test iniziale emerge un valore > 2 mg/dl, è consentita una ripetizione del test durante il periodo di screening
    • Emoglobina (Hb) Età (anni) M (g/dl) F (g/dl) 6-11 :10.0 – 15.0 10.0 – 15.0; 12-18: 11.0 – 16.5 10.5 – 15.5
    12. Tutte le donne in età fertile (FCBP) devono praticare l'astinenza* dal contatto eterosessuale o utilizzare una delle opzioni dei contraccettivi approvati come descritto di seguito durante il trattamento con apremilast e durante qualsiasi interruzione della somministrazione della dose e per almeno 28 giorni dopo la somministrazione dell'ultima dose di apremilast. Ai fini del presente studio, un soggetto di sesso femminile viene considerato in età fertile se ha >= 12 anni o ha raggiunto il menarca, a seconda dell’evento che si verifica per primo.
    Al momento dell'ingresso nello studio e in qualsiasi momento durante lo studio, quando le misure contraccettive di un soggetto di sesso femminile in età fertile o le sue possibilità di entrare in gravidanza cambiano, lo Sperimentatore istruirà il soggetto riguardo all’astinenza o alle opzioni di contraccezione e all'uso corretto e coerente di metodi contraccettivi efficaci al fine di prevenire la gravidanza con successo.
    I soggetti di sesso F in età fertile devono sottoporsi a un test di gravidanza con esito negativo allo screening e alla baseline. Tutti i soggetti FCBP che praticano attività che possono portare al concepimento devono usare una delle opzioni contraccettive approvate descritte di seguito:
    Opz. 1: Uno dei seguenti metodi di elevata efficacia: contraccezione ormonale (per esempio pillola contraccettiva, anello intravaginale, cerotto transdermico, iniezione, impianto); dispositivo intrauterino (IUD); legatura delle tube; o vasectomia del partner. OPPURE Opz. 2: Profilattico maschile o femminile in lattice o non in lattice NON realizzato in membrana naturale (animale) (ad esempio, poliuretano); PIÙ un metodo di barriera aggiuntivo: (a) diaframma con spermicida; (b) cappuccio cervicale con spermicida; oppure (c) spugna contraccettiva con spermicida
    NOTA: l’opzione 2 potrebbe non essere accettabile come opzione di contraccezione altamente efficace in tutti i Paesi in base alle linee guida/normative locali.
    E.4Principal exclusion criteria
    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 Baseline7. 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 (see study protocol for details)
    19. to 21 see study protocol
    La presenza di uno qualsiasi dei seguenti criteri escluderà il soggetto dall'arruolamento:
    1. Altre malattie diverse dalla psoriasi, anamnesi di malattia clinicamente significativa (a giudizio dello sperimentatore) di tipo cardiaco, endocrinologico, polmonare, neurologico, psichiatrico, epatico, renale, ematologico, immunologico o altra malattia importante incontrollata. 2.Qualsiasi condizione, inclusa la presenza di anomalie di laboratorio, o malattia psichiatrica che esponga il soggetto a rischi inaccettabili qualora dovesse partecipare allo studio 3. Qualsiasi condizione che confonda la capacità di interpretare i dati provenienti dallo studio. 4. Evidenza di condizioni cutanee, diverse dalla psoriasi, che interferirebbero con le valutazioni cliniche. 5. Gravidanza o allattamento 6.Psoriasi guttata, eritrodermica o pustolosa allo screening e alla baseline 7. Riacutizzazione e ricaduta della psoriasi entro 4 settimane prima dello screening
    8. Positività per l’antigene di superficie dell’epatite B o anticorpo anti-epatite C allo screening
    9. Anamnesi di positività all’infezione da virus dell'immunodeficienza umana (HIV) o immunodeficienze congenite e acquisite (ad esempio, immunodeficienza comune variabile, deficienza di immunoglobulina A)
    10. Tubercolosi attiva (TB) o anamnesi di TB trattata in modo incompleto
    11. Anamnesi di infezioni significative ricorrenti
    12. Infezione attiva o infezione trattata con trattamento antibiotico entro 2 settimane dalla prima dose
    13. Anamnesi di tumore maligno o tumore maligno attivo
    14. Anamnesi di allergia/intolleranza a qualsiasi componente del prodotto sperimentale, ovvero apremilast, lattosio monoidrato, cellulosa microcristallina, sodio croscaramelloso, magnesio stearato, ipromellosa 15cP, diossido di titanio, colorante alimentare chimico polidestrosio, talco, maltodestrina, trigliceridi a catena media, ossido di ferro rosso, ossido di ferro giallo e ossido di ferro nero.
    15. Deficit nel metabolismo del lattosio, ovvero galattosio-1-fosfato uridililtransferasi, UDP-galattosio 4-epimerasi, o galattochinasi o sindrome di Fanconi Bickel, compresi eventuali deficit congeniti di lattasi e malassorbimento del glucosio-galattosio.
    16. Anamnesi di precedente tentativo di suicidio in qualsiasi momento della vita del soggetto prima dello screening o della randomizzazione nello studio, oppure malattia psichiatrica importante che abbia richiesto il ricovero ospedaliero entro 3 anni dalla
    firma dell’assenso e del consenso informato 17. "Sì" come risposta a qualsiasi domanda sulla Scala di Valutazione del Rischio di Suicidio - Columbia durante lo screening o alla baseline
    18. Uso concomitante attuale o previsto delle seguenti terapie che possono avere un possibile effetto sulla psoriasi (vedi protocollo di studio x dettagli)
    19 -21 . vedi protocollo di studio
    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.
    Valutazione globale statica del medico (sPGA) - Percentuale di soggetti con un punteggio sPGA clear (0) o quasi clear (1) con almeno una riduzione di 2 punti rispetto alla baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint will be evaluated at the end of Week 16.
    L'endpoint primario verrà valutato alla fine della Settimana 16.
    E.5.2Secondary end point(s)
    Psoriasis Area Severity Index-75 (PASI-75) - Proportion of subjects
    who achieve at least a 75% reduction in PASI (PASI-75) from baseline
    PASI-50 - Proportion of subjects who achieve at least a 75% reduction
    in PASI (PASI-75) from baseline
    PASI - Percent change from baseline in total PASI score
    Children's Dermatological Life Quality Index (CDLQI) - Change from
    baseline in CDLQI score
    CDLQI (0/1) - Proportion of subjects who achieve CDLQI (0/1)
    Body Surface Area (BSA) - Percent change from baseline in affected BSA
    Indice 75 di gravità dell’area con psoriasi (PASI-75) - Percentuale di soggetti che raggiungono almeno una riduzione del 75% nel PASI (PASI-75) dalla baseline PASI-50 - Percentuale di soggetti che raggiungono almeno una riduzione del 75% nel PASI (PASI-75) dalla baseline
    PASI - Variazione percentuale dalla baseline nel punteggio PASI totale
    Indice dermatologico della qualità di vita dei bambini (CDLQI) - Variazione dalla baseline nel punteggio CDLQI
    CDLQI (0/1) - Percentuale di soggetti che raggiungono CDLQI (0/1)
    Area di superficie corporea (BSA) - Variazione percentuale dalla baseline nella BSA interessata
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at the end of Week 16.
    Tutti gli endpoint secondari saranno valutati alla fine della Settimana 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 concerned9
    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 Information not present in EudraCT
    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
    Mexico
    Russian Federation
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Netherlands
    Spain
    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.
    La conclusione della sperimentazione è definita come la data dell'ultima visita dell'ultimo soggetto che conclude il follow-up post-trattamento o la data di ricezione dell'ultimo dato dall'ultimo soggetto, dato necessario per le valutazioni di efficacia e/o sicurezza, come preliminarmente specificato nel protocollo, a seconda di quale delle due date sia l'ultima.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days5
    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: 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 state25
    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.
    Tutti i sogg. eleggibili che completano Fase di estensione con apremilast potranno decidere di arruolarsi in uno studio a lungo termine separato (per periodo max 4 anni o fino all'approvazione, a seconda dell'evento che si verifica per primo). I sogg.i che scelgono di non partecipare allo studio a lungo termine, o di interrompere anticipatamente la partecipazione allo studio, dovranno tornare per le visite follow-up osservazionale quattro, otto e quattordici settimane dopo l'ultima dose di 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 Decision2019-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-23
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA