Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

NCT04804553 · tracked via the Priya Life Science UK tracker

Sponsor

Amgen

Phase

Phase 3

Started

2022-03-17

Last updated

2026-09-03

Condition(s) studied

Active Juvenile Psoriatic Arthritis

Investigational drug(s) / intervention(s)

ApremilastPlacebo

Apremilast: Participants will receive apremilast orally.

Placebo: Participants will receive the matching placebo orally.

Study 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

Sex

ALL

Min age

5 Years

Max age

17 Years

Healthy volunteers

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 outcome measure(s)

Number of Participants who Achieve American College of Rheumatology Pediatric (ACR) Pedi 30 Response at Week 16 — 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 \[CRP\]).

Trial sites (45)

Facility	City	Region	Status
Landeskrankenhaus Bregenz	Bregenz	Austria	Recruiting
Universitair Ziekenhuis Gent	Ghent	Belgium	Active Not Recruiting
Centre Hospitalier Regional de la Citadelle	Liège	Belgium	Active Not Recruiting
Ziekenhuis Netwerk Antwerpen Jan Palfijn	Merksem	Belgium	Active Not Recruiting
Hospices Civils de Lyon Hopital Femme Mere Enfant	Bron	France	Recruiting
Hopital Jeanne de Flandre	Lille	France	Recruiting
Charite - Universitaetsmedizin Berlin, Campus Virchow	Berlin	Germany	Recruiting
Universitaetsklinikum Dresden	Dresden	Germany	Terminated
An der Schoen Klinik Hamburg Eilbek	Hamburg	Germany	Terminated
Asklepios Kinderklinik Sankt Augustin GmbH	Sankt Augustin	Germany	Terminated
Agia Sofia Children Hospital	Athens	Greece	Recruiting
Attikon University General Hospital	Athens	Greece	Terminated
General Hospital of Thessaloniki Ippokrateio	Thessaloniki	Greece	Recruiting
Ospedale Santissima Annunziata	Chieti	Italy	Terminated
IRCCS Istituto Giannina Gaslini	Genova	Italy	Terminated
Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini	Milan	Italy	Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu	Roma	Italy	Terminated
Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine	Vilnius	Lithuania	Recruiting
Universitair Medisch Centrum Utrecht	Utrecht	Netherlands	Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie	Krakow	Poland	Active Not Recruiting
SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lodz	Poland	Active Not Recruiting
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher	Warsaw	Poland	Active Not Recruiting
Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz	Lisbon	Portugal	Terminated
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria	Lisbon	Portugal	Recruiting
Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos	Ponte de Lima	Portugal	Recruiting
Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao	Porto	Portugal	Terminated
Unidade Local de Saude de Gaia-Espinho, EPE	Vila Nova de Gaia	Portugal	Recruiting
Spitalul Clinic de Urgenta pentru Copii Cluj	Cluj-Napoca	Romania	Terminated
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara	Timișoara	Romania	Recruiting
Panorama Medical Centre	Panorama	Western Cape	Recruiting
Groote Schuur Hospital	Cape Town	South Africa	Terminated
Hospital Universitario de Canarias	San Cristóbal de La Laguna	Canary Islands	Recruiting
Hospital Universitari Vall d Hebron	Barcelona	Catalonia	Recruiting
Hospital Sant Joan de Deu	Esplugues de Llobregat	Catalonia	Recruiting
Hospital Universitari i Politecnic La Fe	Valencia	Valencia	Recruiting
Hospital Universitario Ramon y Cajal	Madrid	Spain	Recruiting
Hospital Universitario La Paz	Madrid	Spain	Terminated
Hacettepe Universitesi Tip Fakultesi Hastanesi	Ankara	Turkey (Türkiye)	Recruiting
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi	Istanbul	Turkey (Türkiye)	Recruiting
Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul	Turkey (Türkiye)	Recruiting

+ 5 more sites — see the full list on the official registry below.

On this site

📄 Otezla (apremilast) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04804553 on ClinicalTrials.gov ↗ ← All trials in the UK