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    Summary
    EudraCT Number:2022-003024-41
    Sponsor's Protocol Code Number:20190531
    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:2023-01-16
    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 number2022-003024-41
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, Long-term Extension Study of Apremilast in Children 2 Years of Age or Older With Oral Ulcers Associated With Behçet's Disease or 5 Years of Age or Older With Juvenile Psoriatic Arthritis
    Studio di estensione a lungo termine di fase III, multicentrico, in aperto su apremilast somministrato a bambini di età pari o superiore a 2 anni con ulcere orali associate alla malattia di Behçet o di età pari o superiore a 5 anni con artrite psoriasica giovanile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Apremilast study in children with active oral ulcers associated with Behçet's Disease or Juvenile Psoriatic Arthritis
    Studio su apremilast in bambini con ulcere orali attive associate alla malattia di Behçet o alla artrite psoriasica giovanile
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code number20190531
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/353/2022
    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. a socio unico
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia E. Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone 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 AuthorisationItaly
    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 [AMG 407]
    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 08141-41-9
    D.3.9.2Current sponsor codeAMG 407
    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 - 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 AuthorisationItaly
    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 [AMG 407]
    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 codeAMG 407
    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 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 [AMG 407]
    D.3.4Pharmaceutical form Oral/rectal 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.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeAMG 407
    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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with active Behçet's Disease or Juvenile Psoriatic Arthritis
    Soggetti con malattia di Behçet attiva o artrite psoriasica giovanile
    E.1.1.1Medical condition in easily understood language
    Behçet Disease: inflammation in blood vessels, manifests as mouth or genital ulcers with eye & skin lesions
    JPA:Joint inflammation with psoriatic disorder affecting pediatric pts
    Malattia di Behçet: infiammazione dei vasi sanguigni, con ulcere della bocca o dei genitali e lesioni oculari e cutanee.
    JPA: infiammazione articolare con disturbo psoriasico in età pediatrica.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10004212
    E.1.2Term Behcet's disease
    E.1.2System Organ Class 100000004866
    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
    Evaluate the long-term safety of apremilast in subjects 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active JPsA that have completed Study 20190530 or Study 20190529
    Valutare la sicurezza a lungo termine di apremilast in soggetti di età pari o superiore a 2 anni con ulcere orali associate alla malattia di Behçets o di età pari o superiore a 5 anni con JPsA attiva che hanno completato lo studio 20190530 o lo studio 20190529.
    E.2.2Secondary objectives of the trial
    None
    Nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject's legally authorized representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
    2. Subject must have completed week 52 (Apremilast Active Treatment Phase) of Study 20190529 (from France and Turkey sites only) or Study 20190530 where drug is not commercially available in their country.
    3. Subject must have an age and sex specific body mass index (BMI) value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart (Appendix 11.7) for children and
    adolescents (CDC, 2000) at randomization.
    4. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
    5. Subject must have acceptable benefit/risk for continued treatment with apremilast.
    1. Il rappresentante legalmente autorizzato del soggetto ha fornito il consenso informato quando il soggetto è legalmente troppo giovane per fornire il consenso informato e il soggetto ha fornito l'assenso scritto in base alle normative e/o linee guida locali prima dell'avvio di qualsiasi attività/procedura specifica dello studio.
    2. Il soggetto deve aver completato la settimana 52 (fase di trattamento attivo con Apremilast) dello studio 20190529 (solo per i siti di Francia e Turchia) o dello studio 20190530 se il farmaco non è disponibile in commercio nel suo Paese.
    3. Il soggetto deve avere un indice di massa corporea (BMI) specifico per età e sesso non inferiore al 5° percentile della tabella di crescita dei Centers for Disease Control (CDC) (Appendice 11.7) per bambini e adolescenti (CDC, 2000).
    adolescenti (CDC, 2000) al momento della randomizzazione.
    4. Il soggetto è disposto e in grado di rispettare il programma di visite dello studio e gli altri requisiti del protocollo.
    5. Il soggetto deve avere un rapporto beneficio/rischio accettabile per il proseguimento del trattamento con apremilast.
    E.4Principal exclusion criteria
    1. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the week 52 visit on Study 20190529 (subjects from France and Turkey sites only) or Study 20190530.
    2. Scheduled surgery or other interventions that would interrupt the subject's participation in the study.
    3. Female subjects of childbearing potential (for the purpose of this study, a female subject is considered of childbearing potential if she is 12 years old or older or has reached menarche, whichever occurred first) unwilling to use protocol specified method of contraception see Appendix 5 (Section 11.5) during treatment and for an additional 30 days after the last dose of investigational product.
    4. Female subjects planning to become pregnant while on study through 30 days after the last dose of investigational product.
    5. Female subjects of childbearing potential with a positive pregnancy test assessed at week 0 by a highly sensitive urine or serum pregnancy test.
    6. Subject has known sensitivity to any of the products to be administered during dosing.
    7. Subject likely to not be available to complete all protocol-required study visits.
    1. Rispondere "Sì" a qualsiasi domanda della Columbia-Suicide Severity Rating Scale (C-SSRS) alla settimana 52 dello Studio 20190529 (solo per i soggetti provenienti dai siti di Francia e Turchia) o dello Studio 20190530.
    2. Interventi chirurgici programmati o altri interventi che interrompano la partecipazione del soggetto allo studio.
    3. Soggetti di sesso femminile con potenziale fertile (ai fini di questo studio, un soggetto di sesso femminile è considerato con potenziale fertile se ha 12 anni o più o ha raggiunto il menarca, a seconda di quale dei due eventi si è verificato per primo) che non sono disposti a utilizzare il metodo contraccettivo specificato dal protocollo, come indicato nell'Appendice 5 (Sezione 11.5), durante il trattamento e per altri 30 giorni dopo l'ultima dose di prodotto in studio.
    4. Soggetti di sesso femminile che pianificano una gravidanza durante lo studio fino a 30 giorni dopo l'ultima dose di prodotto in studio.
    5. Soggetti di sesso femminile con potenziale fertile con un test di gravidanza positivo valutato alla settimana 0 con un test di gravidanza altamente sensibile sulle urine o sul siero.
    6. Il soggetto ha una sensibilità nota a uno qualsiasi dei prodotti da somministrare durante il dosaggio.
    7. Il soggetto potrebbe non essere disponibile a completare tutte le visite di studio richieste dal protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    - Adverse events: Type, frequency, severity, and relationship to apremilast
    - Columbia-Suicide Severity rating Scale (C-SSRS)
    - Tanner Staging
    - Body weight, height, and body mass index (BMI)
    - Vital signs and laboratory parameters
    - Eventi avversi: Tipo, frequenza, gravità e relazione con apremilast
    - Scala di valutazione della gravità del suicidio di Columbia (C-SSRS)
    - Stadiazione di Tanner
    - Peso corporeo, altezza e indice di massa corporea (BMI)
    - Segni vitali e parametri di laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 0, 26 , 52, 78, 104, 130 , 156 , 182 , 208 and 212
    Settimane 0, 26 , 52, 78, 104, 130 , 156 , 182 , 208 e 212
    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 No
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Israel
    France
    Switzerland
    Greece
    Italy
    Turkey
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 years9
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months11
    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: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children aged 2-11 years old and adolescents aged 12-17 years old
    - Bambini di 2-11 anni e adolescenti di 12-17 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 48
    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)
    Not applicable
    Non applicabile
    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 Decision2023-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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