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Estudio pediátrico de apremilast en niños con artritis psoriásica juvenil activa (PEAPOD)

16 de octubre de 2026 actualizado por: Amgen

Estudio de fase 3, multicéntrico, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos para evaluar la eficacia, la seguridad y la farmacocinética de apremilast en niños de 5 a menos de 18 años con artritis psoriásica juvenil activa (PEAPOD)

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Amgen Call Center
  • Número de teléfono: 866-572-6436
  • Correo electrónico: medinfo@amgen.com

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 13353
        • Reclutamiento
        • Charite - Universitaetsmedizin Berlin, Campus Virchow
      • Dresden, Alemania, 01307
        • Terminado
        • Universitaetsklinikum Dresden
      • Hamburg, Alemania, 22081
        • Terminado
        • An der Schoen Klinik Hamburg Eilbek
      • Sankt Augustin, Alemania, 53757
        • Terminado
        • Asklepios Kinderklinik Sankt Augustin GmbH
  • Bélgica
      • Ghent, Bélgica, 9000
        • Terminado
        • Universitair Ziekenhuis Gent
      • Liège, Bélgica, 4000
        • Terminado
        • Centre Hospitalier Regional de la Citadelle
      • Merksem, Bélgica, 2170
        • Terminado
        • Ziekenhuis Netwerk Antwerpen Jan Palfijn
  • España
      • Madrid, España, 28034
        • Reclutamiento
        • Hospital Universitario Ramon y Cajal
      • Madrid, España, 28046
        • Terminado
        • Hospital Universitario La Paz
    • Canary Islands
      • San Cristóbal de La Laguna, Canary Islands, España, 38320
        • Reclutamiento
        • Hospital Universitario de Canarias
    • Catalonia
      • Barcelona, Catalonia, España, 08035
        • Reclutamiento
        • Hospital Universitari Vall d Hebron
      • Esplugues de Llobregat, Catalonia, España, 08950
        • Reclutamiento
        • Hospital Sant Joan de Deu
    • Valencia
      • Valencia, Valencia, España, 46026
        • Reclutamiento
        • Hospital Universitari i Politecnic La Fe
  • Francia
      • Bron, Francia, 69677
        • Reclutamiento
        • Hospices Civils de Lyon Hopital Femme Mere Enfant
      • Lille, Francia, 59037
        • Reclutamiento
        • Hopital Jeanne de Flandre
  • Grecia
      • Athens, Grecia, 12462
        • Terminado
        • Attikon University General Hospital
      • Athens, Grecia, 11527
        • Terminado
        • Agia Sofia Children Hospital
      • Thessaloniki, Grecia, 54642
        • Reclutamiento
        • General Hospital of Thessaloniki Ippokrateio
  • Italia
      • Chieti, Italia, 66100
        • Terminado
        • Ospedale Santissima Annunziata
      • Genova, Italia, 16147
        • Terminado
        • IRCCS Istituto Giannina Gaslini
      • Milan, Italia, 20122
        • Reclutamiento
        • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
      • Roma, Italia, 00165
        • Terminado
        • IRCCS Ospedale Pediatrico Bambino Gesu
  • Lituania
      • Vilnius, Lituania, 08406
        • Reclutamiento
        • Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
  • Países Bajos
      • Utrecht, Países Bajos, 3584 EA
        • Reclutamiento
        • Universitair Medisch Centrum Utrecht
  • Polonia
      • Krakow, Polonia, 31-503
        • Terminado
        • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
      • Lodz, Polonia, 91-738
        • Terminado
        • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
      • Warsaw, Polonia, 02-637
        • Terminado
        • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Reclutamiento
        • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
      • Lisbon, Portugal, 1349-019
        • Terminado
        • Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
      • Ponte de Lima, Portugal, 4990-041
        • Reclutamiento
        • Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
      • Porto, Portugal, 4200-319
        • Terminado
        • Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
      • Vila Nova de Gaia, Portugal, 4430-502
        • Reclutamiento
        • Unidade Local de Saude de Gaia-Espinho, EPE
  • Reino Unido
      • Birmingham, Reino Unido, B4 6NH
        • Terminado
        • Birmingham Childrens Hospital
      • Liverpool, Reino Unido, L12 2AP
        • Terminado
        • Alder Hey Childrens Hospital
      • Nottingham, Reino Unido, NG7 2UH
        • Reclutamiento
        • Nottingham Childrens Hospital
      • Oxford, Reino Unido, OX3 7LD
        • Reclutamiento
        • John Radcliffe Hospital
  • Rumania
      • Cluj-Napoca, Rumania, 400124
        • Terminado
        • Spitalul Clinic de Urgenta pentru Copii Cluj
      • Timișoara, Rumania, 300011
        • Reclutamiento
        • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
  • Sudáfrica
      • Cape Town, Sudáfrica, 7935
        • Terminado
        • Groote Schuur Hospital
    • Western Cape
      • Panorama, Western Cape, Sudáfrica, 7500
        • Reclutamiento
        • Panorama Medical Centre
  • Turquía (Türkiye)
      • Ankara, Turquía (Türkiye), 06100
        • Reclutamiento
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turquía (Türkiye), 34098
        • Reclutamiento
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Istanbul, Turquía (Türkiye), 34093
        • Reclutamiento
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Istanbul, Turquía (Türkiye), 34764
        • Reclutamiento
        • Umraniye Egitim ve Arastirma Hastanesi

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

5 años a 17 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Male or Female participants 5 to < 18 years of age at the time of randomization.

  • Participant must have a confirmed diagnosis of juvenile psoriatic arthritis (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

  • Active disease: at least 3 active joints.

  • Inadequate response (at least 2 months) or intolerance to ≥ 1 disease-modifying anti-rheumatic drugs (DMARD), (which may include methotrexate [MTX] or biologic agents).

Exclusion Criteria:

  • 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, 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 juvenile idiopathic arthritis (JIA).

  • Rheumatic autoimmune disease other than psoriatic arthritis (PsA), including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia.

  • Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Apremilast

Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.
Droga: Apremilast

Participants will receive apremilast orally.

Otros nombres:
  • Otezla®
Comparador de placebos: Placebo to Apremilast

Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.
Droga: Apremilast

Participants will receive apremilast orally.

Otros nombres:
  • Otezla®
Droga: Placebo

Participants will receive the matching placebo orally.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
Periodo de tiempo: Baseline to Week 16

The ACR Pedi 30 is defined as a minimum of 30 percent improvement from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >30 percent.

The ACR Pedi consists of 6 core criteria:

  1. physician global assessment (PGA) of disease activity (visual analog scale [VAS]) where 0 represents no disease activity and 100 represents the most disease activity
  2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
  3. functional ability (assessed using the Childhood Health Assessment Questionnaire [CHAQ]);
  4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both)
  5. number of joints with limited range of motion
  6. laboratory marker of inflammation (C-reactive protein [CRP]).
Baseline to Week 16

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en el número de articulaciones con rango de movimiento limitado en la semana 16
Periodo de tiempo: Línea de base a la semana 16
Línea de base a la semana 16
Cambio desde el inicio en el marcador de laboratorio de inflamación (proteína C reactiva) en la semana 16
Periodo de tiempo: Línea de base a la semana 16
Línea de base a la semana 16
Número de participantes que experimentan uno o más eventos adversos emergentes del tratamiento (TEAE)
Periodo de tiempo: Hasta la Semana 56
Hasta la Semana 56
Cambio desde el inicio en el peso corporal en la semana 56
Periodo de tiempo: Línea de base hasta la semana 56
Línea de base hasta la semana 56
Cambio desde el inicio en altura en la semana 56
Periodo de tiempo: Línea de base hasta la semana 56
Línea de base hasta la semana 56
Cambio desde el inicio en el índice de masa corporal (IMC) en la semana 56
Periodo de tiempo: Línea de base hasta la semana 56
Línea de base hasta la semana 56
Concentraciones plasmáticas de apremilast
Periodo de tiempo: Semana 2: 0-5 horas después de la dosis; Semana 8: 2 horas después de la dosis; Semana 16: 4 horas después de la dosis; Semana 28: predosis; Semana 40: predosis; Semana 52: predosis
Semana 2: 0-5 horas después de la dosis; Semana 8: 2 horas después de la dosis; Semana 16: 4 horas después de la dosis; Semana 28: predosis; Semana 40: predosis; Semana 52: predosis
Change from Baseline in Participants Assessment of Pain at Week 16
Periodo de tiempo: Baseline to Week 16

The participants assessment of pain will be assessed using a visual analogue scale (VAS). Participants will be asked to place a vertical line on a 100-mm VAS where the left-hand boundary represents "no pain" and the right-hand boundary represents "worst possible pain".
Baseline to Week 16
Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
Periodo de tiempo: Baseline to Week 16

The ACR Pedi 20, 50, 70 and 90 is defined as a minimum of either 20 percent, 50 percent. 70 percent or 90 percent improvement respectively from baseline in a minimum of 3 out of 6 components, with no more than 1 component worsening by >20 percent, >50 percent, >70 percent or >90 percent respectively.

The ACR Pedi consists of 6 core criteria:

  1. PGA of disease activity (VAS) where 0 represents no disease activity and 100 represents the most disease activity
  2. assessment of overall well-being (VAS) where 0 represents very well and 100 represents very poor for overall well-being
  3. functional ability (assessed using the CHAQ)
  4. number of joints with active arthritis (defined as joints with swelling not caused by deformity or joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both) 5. number of joints with limited range of motion

6. laboratory marker of inflammation (CRP).
Baseline to Week 16
Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
Periodo de tiempo: Baseline to Week 16

PGA of disease activity is assessed using a visual analog scale (VAS), where 0 represents no disease activity and 100 represents the most disease activity.
Baseline to Week 16
Change from Baseline in the Assessment of Overall Well-being at Week 16
Periodo de tiempo: Baseline to Week 16

Assessment of overall well-being is assessed using a visual analog scale (VAS), where 0 represents very well and 100 represents very poor for overall well-being. This assessment can be completed by either the participant or the parent/caregiver.
Baseline to Week 16
Change from Baseline in the Number of Joints with Active Arthritis at Week 16
Periodo de tiempo: Baseline to Week 16

Active arthritis is defined as joints with swelling not caused by deformity of joints, in the absence of swelling, with limitation of passive motion accompanied by pain, tenderness, or both.
Baseline to Week 16
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
Periodo de tiempo: Baseline to Week 16

The CHAQ will be used to assess physical ability and functional status of participants as well as their quality of life.

The CHAQ consists of 20 items concerning difficulty in performing the following 8 activities of daily living: dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping, and activities. Subjects will choose from 4 responses ranging from 0 (without any difficulty) to 3 (unable to do). A lower score indicates a better outcome. The subject's/parent's/caregiver's assessment of arthritis-related pain will also be assessed on a VAS that is part of the CHAQ.
Baseline to Week 16
Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
Periodo de tiempo: Baseline to Week 16

JADAS is a composite score of participant well-being visual analog scale (VAS) score, physician global assessment (PGA) VAS score, active joint count, and laboratory marker of inflammation (C-reactive protein [CRP]).

There are 4 components of the JADAS:

  1. Active joint count (71 joints)
  2. PGA (0 to 100) measured on a VAS
  3. Patient/parent global assessment of well-being (0 to 100) measured on a VAS
  4. CRP (normalized to a 0 to 10 scale)

The active joint count is taken from 71 joints: Temporomandibular joints, cervical spine, glenohumeral joints, acromioclavicular joints, sternoclavicular joints, elbows, wrists, metacarpophalangeal joints, interphalangeal joints, proximal interphalangeal joints, distal interphalangeal joints, hips, subtalar joints, midfoot joints, knees and ankles .

The total score is calculated by adding all 4 components of the JADAS. The score for the JADAS ranges from 0 to 101 where a lower score indicates a better outcome.
Baseline to Week 16
Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
Periodo de tiempo: Baseline to Week 16

PsA flares are defined as more than or equal to 30 percent worsening in at least 3 of 6 American College of Rheumatology Pediatric (ACR Pedi) core set variables with a more than or equal to 30 percent improvement in not more than 1 of 6 ACR Pedi core set variables.
Baseline to Week 16
Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
Periodo de tiempo: Baseline to Week 16

PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.

The PASI score is determined only for subjects whose BSA involved by psoriasis is

≥3 percent. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on the 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90 percent < 100 percent involvement). The sum of scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percentage of BSA. The resultant values for each anatomic region are then summed to yield the PASI score.
Baseline to Week 16
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
Periodo de tiempo: Up to Week 56

The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior is defined as the number of participants who answer "yes" at any time during the study (up to end of safety follow-up, Week 56) to one of the 10 categories:

Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Up to Week 56
Change from Baseline in Tanner Staging at Week 52
Periodo de tiempo: Baseline to Week 52

Tanner Staging of sexual development assessment will be used to assess sexual maturity. Tanner Staging assessment consists of 3 domains (pubic hair, breast development, and other changes) for girls and 4 domains (pubic hair, penis development, testes development, and other changes) for boys. Stages range from 1-5, with 1 indicating preadolescent and 5 adult.
Baseline to Week 52
Taste and Acceptability of Apremilast
Periodo de tiempo: Baseline and Week 2

Taste and acceptability will be assessed using a questionnaire with a 7-point faces Likert Scale, with 1 ranging from "super bad" to 7 "super good" and questions to determine whether the participants are able to take the treatment medication.
Baseline and Week 2

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Amgen

Investigadores

  • Director de estudio: MD, Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

17 de marzo de 2022

Finalización primaria (Estimado)

21 de marzo de 2028

Finalización del estudio (Estimado)

29 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

16 de marzo de 2021

Primero enviado que cumplió con los criterios de control de calidad

16 de marzo de 2021

Publicado por primera vez (Actual)

18 de marzo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20190529

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Marco de tiempo para compartir IPD

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Criterios de acceso compartido de IPD

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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