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    Summary
    EudraCT Number:2019-002788-88
    Sponsor's Protocol Code Number:20190529
    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:2021-05-20
    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 number2019-002788-88
    A.3Full title of the trial
    A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apremilast in Children From 5 to Less Than 18 Years of Age With Active Juvenile Psoriatic Arthritis (PEAPOD)
    Studio di fase III, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli, atto a valutare l’efficacia, la sicurezza e la farmacocinetica di apremilast nei bambini di età compresa tra i 5 e i 18 anni con artrite psoriasica giovanile attiva (PEAPOD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Apremilast Study in Children with Active Juvenile Psoriatic Arthritis
    Studio con apremilast nei bambini affetti da artrite psoriasica giovanile attiva
    A.3.2Name or abbreviated title of the trial where available
    PEAPOD
    PEAPOD
    A.4.1Sponsor's protocol code number20190529
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/388/2019
    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 S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@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 - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
    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 [AMG407]
    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
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeAMG407
    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: 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 - 30 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/ALU) - 56 COMPRESSE
    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 [AMG407]
    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
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeAMG407
    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.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 - 10 MG + 20 MG + 30 MG COMPRESSA RIVESTITA CON FILM USO ORALE - BLISTER (PVC/ALU) IN UN ASTUCCIO - 4 COMPRESSE DA 10 MG + 4 COMPRESSE DA 20 MG +19 COMPRESSE DA 30 MG
    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 [AMG407]
    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
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeAMG407
    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: 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 nameApremilast
    D.3.2Product code [AMG407]
    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 INNApremilast
    D.3.9.2Current sponsor codeAMG407
    D.3.9.4EV Substance CodeSUB130837
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral suspension
    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
    Juvenile psoriatic arthritis
    Artrite psoriasica giovanile
    E.1.1.1Medical condition in easily understood language
    Joint inflammation with Skin disorder (Psoriasis) affecting pediatric individuals.
    Infiammazione delle articolazioni con disturbo della pelle (psoriasi) che colpisce i soggetti pediatrici.
    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 10079454
    E.1.2Term Systemic juvenile idiopathic arthritis
    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
    Estimate the efficacy of apremilast compared with placebo in the treatment of Juvenile Psoriatic Arthritis in pediatric subjects 5 to less
    than 18 years of age;
    Stimare l’efficacia di apremilast rispetto al placebo nel trattamento della JPsA nei soggetti pediatrici di età compresa tra 5 e < 18 anni
    E.2.2Secondary objectives of the trial
    - Estimate effect of apremilast compared to placebo on pain in pediatric subjects (5 to less than 18 years) with JPsA;
    - Estimate effect of apremilast compared to placebo on ACR Pedi 20/50/70/90 response, respective core components, and on juvenile
    arthritis disease activity in pediatric subjects with JPsA;
    - Estimate impact on HRQoL in pediatric subjects with JPsA;
    - Estimate efficacy of apremilast compared to placebo for overall JPsA related disease activity in pediatric subjects with JPsA;
    - Estimate effect of apremilast compared to placebo on psoriatic arthritis flares in pediatric subjects with JPsA;

    Please, refer to protocol for the full list
    - Stimare l’effetto analgesico di apremilast rispetto al placebo nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
    - Stimare l’effetto di apremilast rispetto al placebo sulle risposte ACR Pedi 20/50/70/90, sui rispettivi componenti centrali e sull’attività dell’artrite giovanile nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
    - Stimare l’impatto sull’HRQoL di apremilast rispetto al placebo nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
    - Stimare l’efficacia di apremilast rispetto al placebo per l’attività di malattia globale della JPsA nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;
    - Stimare l’effetto di apremilast rispetto al placebo sui flare di artrite psoriasica nei soggetti pediatrici (di età compresa tra 5 e < 18 anni) con JPsA;

    * Fare riferimento al protocollo per la lista completa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or Female subjects 5 to less than 18 years of age at the time of randomization.
    2. Confirmed diagnosis of JPsA according to the International League of Associations for Rheumatology (ILAR) Edmonton Revision (Petty, 2001) classification criteria of at least 6 months duration:
    -Arthritis and psoriasis, OR
    -Arthritis with at least 2 of the following:
    -Dactylitis
    -Nail pitting or onycholysis
    - Psoriasis in a first-degree relative
    3. Active disease: at least 3 active joints (including distal interphalangeal joints).
    4. Inadequate response (at least 2 months) or intolerance to = 1 DMARD, (which may include MTX or biologic agents).

    Other protocol-defined inclusion criteria apply
    1. Soggetti di sesso maschile o femminile di età compresa tra 5 e < 18 anni al momento della randomizzazione;
    2. Diagnosi confermata di JPsA secondo i criteri di classificazione ILAR, revisione Edmonton (Petty, 2001), della durata di almeno 6 mesi:
    - Artrite o psoriasi, OPPURE
    - Artrite con almeno 2 dei seguenti:
    o Dattilite
    o Pitting ungueale od onicolisi
    o Psoriasi in un parente di primo grado
    3. Malattia attiva: almeno 3 articolazioni attive (incluse le articolazioni interfalangee distali)
    4. Risposta inadeguata (per >= 2 mesi) o intolleranza a >= 1 DMARD, che può includere MTX o agenti biologici.

    Per un elenco completo dei criteri di eleggibilità, consultare il protocollo
    E.4Principal exclusion criteria
    1.Exclusions per ILAR Edmonton Revision (Edmonton, 2001) criteria for JPsA include:
    - Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
    - Ankylosing spondylitis, enthesitis-related arthritis, sacroiliitis with inflammatory bowel disease,
    - Reiter's syndrome, acute anterior uveitis, or a history of one of these disorders in a first-degree relative
    - History of IgM rheumatoid factor on at least 2 occasions at least 3 months apart
    - Presence of systemic JIA.
    2. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.
    3. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
    4. History or evidence of any other clinically significant disorder, condition or disease that could pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    5. Female subject who is (or plans to become) pregnant or breastfeeding.
    6. Female subject of childbearing potential unwilling to use 1 highly effective method of contraception.

    Other protocol-defined exclusion criteria apply.
    1. I criteri di esclusione secondo la classificazione ILAR revisione Edmonton (Petty, 2001), includono:
    - Artrite in un soggetto maschile positivo per HLA-B27 con insorgenza di artrite dopo i 6 anni di età
    - Spondilite anchilosante, artrite correlata ad entesite, sacroileite con malattia infiammatoria intestinale,
    - Sindrome di Reiter, uveite anteriore acuta o anamnesi di uno di questi disturbi in un parente di primo grado
    - Storia del fattore reumatoide IgM in almeno 2 occasioni ad almeno 3 mesi di distanza
    - Presenza di AIG sistemica.
    2. Malattia autoimmune reumatica diversa da PsA, inclusi, ma non limitati a: lupus eritematoso sistemico, malattia mista del tessuto connettivo, sclerodermia, polimiosite o fibromialgia.
    3. Anamnesi pregressa o attuale malattia infiammatoria articolare diversa da AP (ad es. Gotta, artrite reattiva, artrite reumatoide, spondilite anchilosante, malattia di Lyme).
    4. Anamnesi o evidenza di qualsiasi altro disturbo, condizione o malattia clinicamente significativa che potrebbe rappresentare un rischio per la sicurezza dei soggetti o interferire con la valutazione, le procedure o il completamento dello studio.
    5. Soggetto di sesso femminile che è (o intende rimanere) incinta o che allatta.
    6. Soggetto di sesso femminile in età fertile che non desidera utilizzare 1 metodo contraccettivo altamente efficace.

    Per un elenco completo dei criteri di esclusione, consultare il protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants achieving ACR Pedi 30
    Numero di partecipanti che raggiungono una risposta ACR Pedi 30
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline (week 0) to week 16
    dal basale (settimana 0) alla settimana 16
    E.5.2Secondary end point(s)
    - Change in subject's assessment of pain (a);
    - Number of participants achieving ACR Pedi 20/50/70/90 (a);
    - Change in Childhood Heath Assessment Questionnaire (CHAQ) (a);
    - Change in Juvenile Arthritis Disease Activity Score (JADAS) (a);
    - Number of participants who experience PsA flares (a);
    - PASI-75 response at week 16 for subjects with a baseline psoriasis BSA equal or more than 3% (a);
    - Number of participants who experience treatment-emergent adverse events (type, frequency, severity and relationship to apremilast) (b);

    *Please, refer to protocol for the full list
    - Cambiamento nella valutazione del dolore da parte del soggetto (a);
    - Numero di partecipanti che hanno raggiunto ACR Pedi 20/50/70/90 (a);
    - Cambiamento nel Childhood Health Assessment Questionnaire (CHAQ) (a);
    - Variazione del punteggio di Juvenile Arthritis Disease Activity (JADAS) (a);
    - Numero di partecipanti che sperimentano flare di PsA (a);
    - Risposta PASI-75 alla settimana 16 per soggetti con psoriasi al basale che presentano BSA uguale o superiore al 3% (a);
    - Numero di partecipanti che hanno manifestato eventi avversi trattamento correlati (tipo, frequenza, gravità in relazione ad apremilast) (b)

    * Fare riferimento al protocollo per la lista completa
    E.5.2.1Timepoint(s) of evaluation of this end point
    (a) from baseline (week 0) to week 16
    (b) from baseline (week 0) to week 56
    (a) dal basale (settimana 0) alla settimana 16
    (b) dal basale (settimana 0) alla settimana 56
    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 Yes
    E.6.13.1Other scope of the trial description
    dal basale (settimana 0) alla settimana 16
    Gusto e Accettabilità
    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 EEA28
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    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: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 subjects who complete the week 52 visit and all assessments at this visit will have the opportunity to enroll in a separate optional openlabel, long-term study for 4 years or until apremilast is commercially available for JPsA (whichever comes earlier) or until the benefit/risk of apremilast is found not to be acceptable for JPsA, according to either the Sponsor or health authority.
    Tutti i soggetti che completano la visita alla settimana 52 e tutte le valutazioni durante la visita avranno l'opportunità di essere arruolati in uno studio opzionale in aperto, a lungo termine di 4 anni o fino a quando apremilast non sarà disponibile sul mercato per il trattamento della JPsA o fino a quando il profilo beneficio/rischio di apremilast non sarà considerato accettabile per JPsA, secondo lo Sponsor o l'Autorità Competente.
    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 Decision2021-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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