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)

Overview

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.

Interventions

• Drug Apremilast
  Participants will receive apremilast orally.
• Drug Placebo
  Participants will receive the matching placebo orally.

Primary outcome measures

• Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16 [Time frame: Baseline to Week 16]

Secondary outcome measures (12)

• Change from Baseline in Participants Assessment of Pain at Week 16 [Time frame: 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 [Time frame: Baseline to Week 16]
• Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16 [Time frame: Baseline to Week 16]
• Change from Baseline in the Assessment of Overall Well-being at Week 16 [Time frame: Baseline to Week 16]
• Change from Baseline in the Number of Joints with Active Arthritis at Week 16 [Time frame: Baseline to Week 16]
• Change from Baseline in the Number of Joints with Limited Range of Motion at Week 16 [Time frame: Baseline to Week 16]
• Change from Baseline in the Laboratory Marker of Inflammation (C-reactive Protein) at Week 16 [Time frame: Baseline to Week 16]
• Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) at Week 16 [Time frame: Baseline to Week 16]
• Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS) at Week 16 [Time frame: Baseline to Week 16]
• Number of Participants who Experience Psoriatic Arthritis (PsA) Flares at Week 16 [Time frame: 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 [Time frame: Baseline to Week 16]
• Number of Participants who Experience One or More Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 56]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Spain · 6 centers

• Hospital Universitario de Canarias — San Cristóbal de La Laguna
• Hospital Universitari Vall d Hebron — Barcelona
• Hospital Sant Joan de Deu — Esplugues de Llobregat
• Hospital Universitari i Politecnic La Fe — Valencia
• Hospital Universitario Ramon y Cajal — Madrid
• Hospital Universitario La Paz — Madrid

Portugal · 5 centers

• Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz — Lisbon
• Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria — Lisbon
• Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos — Ponte de Lima
• Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao — Porto
• Unidade Local de Saude de Gaia-Espinho, EPE — Vila Nova de Gaia

Germany · 4 centers

• Charite - Universitaetsmedizin Berlin, Campus Virchow — Berlin
• Universitaetsklinikum Dresden — Dresden
• An der Schoen Klinik Hamburg Eilbek — Hamburg
• Asklepios Kinderklinik Sankt Augustin GmbH — Sankt Augustin

Italy · 4 centers

• Ospedale Santissima Annunziata — Chieti
• IRCCS Istituto Giannina Gaslini — Genova
• Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetan — Milan
• IRCCS Ospedale Pediatrico Bambino Gesu — Roma

Turkey (Türkiye) · 4 centers

• Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara
• Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi — Istanbul
• Istanbul Universitesi Cerrahpasa Tip Fakultesi — Istanbul
• Umraniye Egitim ve Arastirma Hastanesi — Istanbul

United Kingdom · 4 centers

• Birmingham Childrens Hospital — Birmingham
• Alder Hey Childrens Hospital — Liverpool
• Nottingham Childrens Hospital — Nottingham
• John Radcliffe Hospital — Oxford

Belgium · 3 centers

• Universitair Ziekenhuis Gent — Ghent
• Centre Hospitalier Regional de la Citadelle — Liège
• Ziekenhuis Netwerk Antwerpen Jan Palfijn — Merksem

Greece · 3 centers

• Agia Sofia Children Hospital — Athens
• Attikon University General Hospital — Athens
• General Hospital of Thessaloniki Ippokrateio — Thessaloniki

Poland · 3 centers

• Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie — Krakow
• SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz
• Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reich — Warsaw

France · 2 centers

• Hospices Civils de Lyon Hopital Femme Mere Enfant — Bron
• Hopital Jeanne de Flandre — Lille

Romania · 2 centers

• Spitalul Clinic de Urgenta pentru Copii Cluj — Cluj-Napoca
• Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara — Timișoara

South Africa · 2 centers

• Panorama Medical Centre — Panorama
• Groote Schuur Hospital — Cape Town

Austria · 1 center

• Landeskrankenhaus Bregenz — Bregenz

Lithuania · 1 center

• Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine — Vilnius

Netherlands · 1 center

• Universitair Medisch Centrum Utrecht — Utrecht

Identifiers

NCT: NCT04804553 · 20190529

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗