Clinical trial NCT04804553: Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Active Juvenile Psoriatic Arthritis
Keywords: Apremilast
Otezla®
Juvenile psoriatic arthritis
Inflammatory disorders
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomized to receive apremilast or placebo in the double-blind 16 week treatment phase. Then, the participants will all receive apremilast for a further 36 weeks in the active treatment phase. The participants not continuing to receive apremilast through the Post-Trial Access Program or Open-label Extension study will then complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change from Baseline in Participants Assessment of Pain at Week 16
timeFrame: Baseline to Week 16
measure: Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in the Assessment of Overall Well-being at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in the Number of Joints with Active Arthritis at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16
timeFrame: Baseline to Week 16
measure: Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16
timeFrame: Baseline to Week 16
measure: Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16
timeFrame: Baseline to Week 16
measure: Psoriasis Area Severity Index (PASI)-75 Response at Week 16 for Participants With a Baseline Psoriasis Body Surface Area (BSA) ≥ 3 percent
timeFrame: Baseline to Week 16
measure: Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 56
measure: Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Week 56
measure: Change from Baseline in Tanner Staging at Week 52
timeFrame: Baseline to Week 52
measure: Change from Baseline in Body Weight at Week 56
timeFrame: Baseline to Week 56
measure: Change from Baseline in Height at Week 56
timeFrame: Baseline to Week 56
measure: Change from Baseline in Body Mass Index (BMI) at Week 56
timeFrame: Baseline to Week 56
measure: Plasma Concentrations of Apremilast
timeFrame: Week 2: 0-5 hours post dose; Week 8: 2 hours post dose; Week 16: 4 hours post-dose; Week 28: pre dose; Week 40: pre dose; Week 52: pre dose
measure: Taste and Acceptability of Apremilast
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: Bregenz
country: Austria
facility: Landeskrankenhaus Bregenz
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Liege
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Merksem
country: Belgium
facility: Ziekenhuis Netwerk Antwerpen Jan Palfijn
city: Bron cedex
country: France
facility: Hospices Civils de Lyon Hopital Femme Mere Enfant
city: Lille
country: France
facility: Hopital Jeanne de Flandre
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Virchow
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Hamburg
country: Germany
facility: An der Schoen Klinik Hamburg Eilbek
city: Sankt Augustin
country: Germany
facility: Asklepios Kinderklinik Sankt Augustin GmbH
city: Athens
country: Greece
facility: Agia Sofia Children Hospital
city: Athens
country: Greece
facility: Attikon University General Hospital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Ippokrateio
city: Chieti
country: Italy
facility: Ospedale Santissima Annunziata
city: Genova
country: Italy
facility: IRCCS Istituto Giannina Gaslini
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
city: Roma
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu
city: Vilnius
country: Lithuania
facility: Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Krakow
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
city: Lodz
country: Poland
facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Cluj
city: Timisoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
city: Panorama
country: South Africa
facility: Panorama Medical Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Canarias
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron
state: Cataluña
city: Esplugues De Llorbregat
country: Spain
facility: Hospital Sant Joan de Deu
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Umraniye Egitim ve Arastirma Hastanesi
city: Birmingham
country: United Kingdom
facility: Birmingham Childrens Hospital
city: Liverpool
country: United Kingdom
facility: Alder Hey Childrens Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Childrens Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: