Actively Recruiting

Phase 3
Age: 5Years - 17Years
All Genders
NCT04804553

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Led by Amgen · Updated on 2026-04-20

60

Participants Needed

45

Research Sites

354 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female participants aged 5 to less than 18 years at randomization
  • Confirmed diagnosis of juvenile psoriatic arthritis (JPsA) for at least 6 months according to ILAR Edmonton Revision criteria
  • Diagnosis includes arthritis and psoriasis, or arthritis plus at least two of the following: dactylitis, nail pitting or onycholysis, psoriasis in a first-degree relative
  • Active disease with at least 3 active joints
  • Inadequate response or intolerance to at least one disease-modifying anti-rheumatic drug (DMARD) for at least 2 months
Not Eligible

You will not qualify if you...

  • Arthritis in an HLA-B27-positive male with arthritis onset after 6 years of age
  • History or presence of ankylosing spondylitis, sacroiliitis with inflammatory bowel disease, Reiter's syndrome, acute anterior uveitis, or these in a first-degree relative
  • History of IgM rheumatoid factor on at least two occasions at least 3 months apart
  • Presence of systemic juvenile idiopathic arthritis (JIA)
  • Other rheumatic autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia
  • Prior history or current inflammatory joint diseases other than psoriatic arthritis, including gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, or Lyme disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 45 locations

1

Landeskrankenhaus Bregenz

Bregenz, Austria, 6900

Actively Recruiting

2

Universitair Ziekenhuis Gent

Ghent, Belgium, 9000

Terminated

3

Centre Hospitalier Regional de la Citadelle

Liège, Belgium, 4000

Terminated

4

Ziekenhuis Netwerk Antwerpen Jan Palfijn

Merksem, Belgium, 2170

Terminated

5

Hospices Civils de Lyon Hopital Femme Mere Enfant

Bron, France, 69677

Actively Recruiting

6

Hopital Jeanne de Flandre

Lille, France, 59037

Actively Recruiting

7

Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, Germany, 13353

Actively Recruiting

8

Universitaetsklinikum Dresden

Dresden, Germany, 01307

Actively Recruiting

9

An der Schoen Klinik Hamburg Eilbek

Hamburg, Germany, 22081

Actively Recruiting

10

Asklepios Kinderklinik Sankt Augustin GmbH

Sankt Augustin, Germany, 53757

Completed

11

Agia Sofia Children Hospital

Athens, Greece, 11527

Actively Recruiting

12

Attikon University General Hospital

Athens, Greece, 12462

Actively Recruiting

13

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, Greece, 54642

Actively Recruiting

14

Ospedale Santissima Annunziata

Chieti, Italy, 66100

Terminated

15

IRCCS Istituto Giannina Gaslini

Genova, Italy, 16147

Actively Recruiting

16

Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

Milan, Italy, 20122

Actively Recruiting

17

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, Italy, 00165

Actively Recruiting

18

Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine

Vilnius, Lithuania, 08406

Actively Recruiting

19

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands, 3584 EA

Actively Recruiting

20

Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie

Krakow, Poland, 31-503

Terminated

21

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, Poland, 91-738

Terminated

22

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

Warsaw, Poland, 02-637

Terminated

23

Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, Portugal, 1349-019

Actively Recruiting

24

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal, 1649-035

Actively Recruiting

25

Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos

Ponte de Lima, Portugal, 4990-041

Actively Recruiting

26

Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao

Porto, Portugal, 4200-319

Terminated

27

Unidade Local de Saude de Gaia-Espinho, EPE

Vila Nova de Gaia, Portugal, 4430-502

Actively Recruiting

28

Spitalul Clinic de Urgenta pentru Copii Cluj

Cluj-Napoca, Romania, 400124

Actively Recruiting

29

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, Romania, 300011

Actively Recruiting

30

Panorama Medical Centre

Panorama, Western Cape, South Africa, 7500

Actively Recruiting

31

Groote Schuur Hospital

Cape Town, South Africa, 7700

Terminated

32

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Canary Islands, Spain, 38320

Actively Recruiting

33

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

34

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, Spain, 08950

Actively Recruiting

35

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain, 46026

Actively Recruiting

36

Hospital Universitario Ramon y Cajal

Madrid, Spain, 28034

Actively Recruiting

37

Hospital Universitario La Paz

Madrid, Spain, 28046

Terminated

38

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye), 06100

Actively Recruiting

39

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, Turkey (Türkiye), 34093

Actively Recruiting

40

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye), 34098

Actively Recruiting

41

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye), 34764

Actively Recruiting

42

Birmingham Childrens Hospital

Birmingham, United Kingdom, B4 6NH

Terminated

43

Alder Hey Childrens Hospital

Liverpool, United Kingdom, L12 2AP

Terminated

44

Nottingham Childrens Hospital

Nottingham, United Kingdom, NG7 2UH

Actively Recruiting

45

John Radcliffe Hospital

Oxford, United Kingdom, OX3 7LD

Actively Recruiting

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Research Team

A

Amgen Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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