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Apremilast pædiatrisk undersøgelse hos børn med aktiv juvenil psoriasisgigt (PEAPOD)

16. oktober 2026 opdateret af: Amgen

En fase 3, multicenter, dobbeltblind, randomiseret, placebokontrolleret, parallel gruppeundersøgelse til evaluering af effektivitet, sikkerhed og farmakokinetik af Apremilast hos børn fra 5 til under 18 år med aktiv juvenil psoriasisgigt (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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Apremilast

Participants will receive apremilast orally.

Andre navne:
  • Otezla®
Placebo komparator: 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.
Medicin: Apremilast

Participants will receive apremilast orally.

Andre navne:
  • Otezla®
Medicin: Placebo

Participants will receive the matching placebo orally.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i antallet af led med begrænset bevægelsesområde i uge 16
Tidsramme: Baseline til uge 16
Baseline til uge 16
Ændring fra baseline i laboratoriemarkøren for inflammation (C-reaktivt protein) i uge 16
Tidsramme: Baseline til uge 16
Baseline til uge 16
Antal deltagere, der oplever en eller flere behandlingsfremkaldte bivirkninger (TEAE'er)
Tidsramme: Op til uge 56
Op til uge 56
Ændring fra baseline i kropsvægt i uge 56
Tidsramme: Baseline til uge 56
Baseline til uge 56
Ændring fra baseline i højde i uge 56
Tidsramme: Baseline til uge 56
Baseline til uge 56
Ændring fra baseline i Body Mass Index (BMI) i uge 56
Tidsramme: Baseline til uge 56
Baseline til uge 56
Plasmakoncentrationer af Apremilast
Tidsramme: Uge 2: 0-5 timer efter dosis; Uge 8: 2 timer efter dosis; Uge 16: 4 timer efter dosis; Uge 28: før dosis; Uge 40: før dosis; Uge 52: før dosis
Uge 2: 0-5 timer efter dosis; Uge 8: 2 timer efter dosis; Uge 16: 4 timer efter dosis; Uge 28: før dosis; Uge 40: før dosis; Uge 52: før dosis
Change from Baseline in Participants Assessment of Pain at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. marts 2022

Primær færdiggørelse (Anslået)

21. marts 2028

Studieafslutning (Anslået)

29. december 2028

Datoer for studieregistrering

Først indsendt

16. marts 2021

Først indsendt, der opfyldte QC-kriterier

16. marts 2021

Først opslået (Faktiske)

18. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20190529

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner