Clinical Trial Page

Summary
EudraCT Number:2015-003314-24
Sponsor's Protocol Code Number:CC-10004-PPSO-001
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2016-01-13
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2015-003314-24
A.3Full title of the trial
A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects with Moderate to Severe Plaque Psoriasis
Estudio abierto y multicéntrico de fase 2 para evaluar la seguridad, tolerabilidad y farmacocinética de apremilast (CC-10004) en pacientes pediátricos con psoriasis en placas entre moderada y grave
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A clinical trial to evaluate if apremilast is safe in children and adolescents with moderate to severe plaque psoriasis as well as assessing how apremilast is processed by the body, and to determine the appropriate dose for them
Un ensayo clínico para evaluar si apremilast es seguro en niños y adolescentes con psoriasis en placas entre moderada y grave, cómo se procesa en el organismo y definir la dosis adecuada
A.4.1Sponsor's protocol code numberCC-10004-PPSO-001
A.7Trial is part of a Paediatric Investigation Plan Yes
A.8EMA Decision number of Paediatric Investigation PlanP/167/2015
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 pointClinicalTrialDisclosure
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+1888-260-1599
B.5.5Fax number+1913-266-0394
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
D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 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
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
D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 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
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
D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 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
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
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Moderate to severe plaque psoriasis in adolescents (ages 12 to 17 years, inclusive) and in children (ages 6 to 11 years, inclusive).
Psoriasis en placas entre moderada y grave en adolescentes (edades de 12 a 17 años, ambas incluidas) y en niños (edades de 6 a 11 años, ambas incluidas).
E.1.1.1Medical condition in easily understood language
Plaque psoriasis
Psoriasis en placas
E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 18.1
E.1.2Level LLT
E.1.2Classification code 10071117
E.1.2Term Plaque psoriasis
E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
E.1.2 Medical condition or disease under investigation
E.1.2Version 18.1
E.1.2Level PT
E.1.2Classification code 10037153
E.1.2Term Psoriasis
E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
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 select a pediatric dose of apremilast based on the safety, tolerability, and PK of apremilast in adolescents and children with moderate to severe plaque psoriasis.
Seleccionar una dosis pediátrica de apremilast basándose en la seguridad, tolerabilidad y farmacocinética (FC) de apremilast (APR) en adolescentes y niños con psoriasis en placas entre moderada y grave.
E.2.2Secondary objectives of the trial
The secondary objective is to evaluate the taste and acceptability of apremilast tablet using a faces Likert Scale.
Evaluar la palatabilidad y aceptabilidad del comprimido de apremilast utilizando una escala Likert de caras.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Male or female 6 to 17 years of age with diagnosis of chronic plaque psoriasis
Pacientes de ambos sexos de entre 6 y 17 años diagnosticados con psoriasis en placas
E.4Principal exclusion criteria
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or which places subject at unacceptable riskif he/she were to participate in the study
Afecciones médicas importantes, resultados anómalos en análisis de laboratorio, enfermedad psiquiátrica que impide al paciente participar en el estudio o que su inclusión pusiese en riesgo al paciente
E.5 End points
E.5.1Primary end point(s)
Safety:
a.Adverse events (AEs)
b.Complete Physical examinations
c.Vital sign measurements
d.Height and weight
e.Clinical laboratory safety tests
f.12-lead electrocardiograms (ECGs)
g.Concomitant medications / procedures
h.Pregnancy testing for females of child-bearing potential
i.Hepatitis B and C testing

j.Pharmacokinetics:
-Maximum observed plasma concentration (Cmax)
- Time to Cmax (tmax)
- Area under the plasma concentration-time curve from time zero extrapolated to
infinity (AUC0-?)
- Area under the plasma concentration-time curve from time zero to 12 hours postdose (AUC0-12)
- Area under the plasma concentration-time curve from time zero to the last
quantifiable concentration (AUC0-t)
- Apparent total plasma clearance when dosed orally (CL/F)
- Apparent total volume of distribution when dosed orally, based on steady-state
(Vss/F) or the terminal phase (Vz/F)
- Terminal-phase elimination half-life (t1/2)
- CL/F
- Apparent total volume of distribution when dosed orally (V/F)
- Absorption rate constant (first-order; Ka)
- Lag (if applicable)
Seguridad:
a. Acontecimientos adversos (AA)
b. Exploraciones físicas
c. Medición de constantes vitales
d. Peso y altura
e. Análisis clínicos de seguridad de laboratorio
f. Electrocardiogramas (ECG) de 12 derivaciones
g. Medicación / procedimientos concomitantes
h. Pruebas de embarazo
i. Pruebas de hepatitis B y C

Farmacocinética
- Máxima concentración plasmática observada (Cmáx)
- Tiempo para Cmáx (tmáx)
- Área bajo la curva de concentración plasmática-tiempo desde tiempo cero extrapolada al infinito (ABC0-?)
- Área bajo la curva de concentración plasmática-tiempo desde tiempo cero hasta 12 horas tras la dosis (ABC0-12)
- Área bajo la curva de concentración plasmática-tiempo desde tiempo cero hasta la última concentración cuantificable (ABC0-t)
- Aclaramiento plasmático aparente total cuando se dosifica por vía oral (CL/F)
- Volumen aparente de distribución total cuando se dosifica por vía oral, basado en el estado estacionario (Vss/F) o la fase terminal (Vz/F)
- Vida media de eliminación de la fase terminal (t1/2)
- CL/F
- Volumen aparente de distribución total cuando se dosifica por vía oral (V/F)
- Constante de velocidad de absorción (primer orden; Ka)
- Demora (si corresponde)
E.5.1.1Timepoint(s) of evaluation of this end point
a.After signing ICF and until 28 days after the last dose
b.Visit 1 and visit 13 (Abbreviated physical exam at all other visits)
c.At each visit from Visit 1 to Visit 12, at any unscheduled visit and at early termination visit
d.At every visit
e.At visits 1 and visit 2, each visit from visit 4 to visit 12, at any unscheduled visit and at early termination visit
f.At visit 1 and after the last dose of investigational product. If a subject withdraws from the study prior to entering the extension treatment period, an ECG should be completed at the Week 2 (Final PK) visit
g.Prior to the Week 102 visit
h.At all visits except Visit 3 (PK), Visit 13, and unscheduled visits
i.At screening
j.At Visit 2 and visit 3 (and Early Termination Visit if visit 3 is not done)
a- Tras la firma del HIP-CI y 28 días después de la última dosis
b. Visitas 1 y 13 (examen físico abreviado en el resto de las visitas)
c. En cada visita desde la 1 a la 12 y en cada visita no programada y en la visita de finalización prematura
d. En cada visita
e. En las visitas 1 y 2, visitas 4 hasta 12, en cada visita no programada y en la visita de finalización prematura
f. En la visita 1 y tras la última dosis del producto en investigación. Si un paciente abandona el estudio antes de la fase de extensión, se debe hacer un ECG en la visita 2 (FC final).
g. Antes de la visita de la semana 102
h. En todas las visitas excepto la 3 (FC), la 13 y las no programadas
i. En la visita de selección
En las visitas 2 y 3 (y la visita de finalización prematura si no se ha hecho la visita 3
E.5.2Secondary end point(s)
Taste and acceptability of apremilast tablet
Palatabilidad y aceptabilidad del comprimido de apremilast
E.5.2.1Timepoint(s) of evaluation of this end point
At Visit 2
En la visita 2
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
Tolerability, taste and acceptability
Tolerabilidad, palatabilidad y aceptabilidad
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) Yes
E.7.3Therapeutic confirmatory (Phase III) No
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 Yes
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.8.3 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 concerned1
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA10
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
Germany
Spain
United Kingdom
United States
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
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 primary, secondary and/or exploratory analysis, as prespecified in the protocol, whichever is the later date.
La finalización del estudio está definida como la fecha en la que tiene lugar la última visita del último paciente en la fase de seguimiento tras el tratamiento o la fecha de recepción del último corte de datos del último sujeto que se requiere para los análisis primarios, secundarios y exploratorios tal como se especifica en el protocolo, lo que suceda más tarde
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months2
E.8.9.2In all countries concerned by the trial days20
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: 32
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: 16
F.1.1.6Adolescents (12-17 years) Yes
F.1.1.6.1Number of subjects for this age range: 16
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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-01-13. Yes
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 state9
F.4.2 For a multinational trial
F.4.2.1In the EEA 22
F.4.2.2In the whole clinical trial 32
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)
The subject's treatment after ending participation in the trial will be at the discretion of the treating physician.
El tratamiento del sujeto tras finalizar su participación en el ensayo será a criterio del facultativo
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 Decision2016-03-02
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2016-02-10
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2019-07-29

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe