New hope for kids with psoriatic arthritis: apremilast trial begins
NCT ID NCT04804553
First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 6 times
Summary
This Phase 3 study tests whether the drug apremilast (Otezla) can safely reduce joint inflammation and pain in children aged 5 to 17 with active juvenile psoriatic arthritis. About 60 participants will receive either apremilast or a placebo pill for 16 weeks. The main goal is to see if at least 30% improvement in arthritis symptoms occurs more often with the drug.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- apremilast (Otezla)
- What this could lead to
- If successful, this could provide a new oral treatment option for children with active juvenile psoriatic arthritis, reducing joint pain and inflammation.
- What could go wrong
- This is a relatively small Phase 3 trial (60 participants), and the drug may not work better than placebo. Apremilast can cause side effects like nausea, diarrhea, and headache.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Active juvenile psoriatic arthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
25 sites in 13 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Agia Sofia Children Hospital
RECRUITINGAthens, 11527, Greece
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Alder Hey Childrens Hospital
TERMINATEDLiverpool, L12 2AP, United Kingdom
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An der Schoen Klinik Hamburg Eilbek
TERMINATEDHamburg, 22081, Germany
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Asklepios Kinderklinik Sankt Augustin GmbH
TERMINATEDSankt Augustin, 53757, Germany
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Attikon University General Hospital
TERMINATEDAthens, 12462, Greece
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Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini
RECRUITINGMilan, 20122, Italy
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Birmingham Childrens Hospital
TERMINATEDBirmingham, B4 6NH, United Kingdom
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Centre Hospitalier Regional de la Citadelle
ACTIVE_NOT_RECRUITINGLiège, 4000, Belgium
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Charite - Universitaetsmedizin Berlin, Campus Virchow
RECRUITINGBerlin, 13353, Germany
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General Hospital of Thessaloniki Ippokrateio
RECRUITINGThessaloniki, 54642, Greece
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Groote Schuur Hospital
TERMINATEDCape Town, 7700, South Africa
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Hacettepe Universitesi Tip Fakultesi Hastanesi
RECRUITINGAnkara, 06100, Turkey (Türkiye)
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Hopital Jeanne de Flandre
RECRUITINGLille, 59037, France
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Hospices Civils de Lyon Hopital Femme Mere Enfant
RECRUITINGBron, 69677, France
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Hospital Sant Joan de Deu
RECRUITINGEsplugues de Llobregat, Catalonia, 08950, Spain
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Hospital Universitari Vall d Hebron
RECRUITINGBarcelona, Catalonia, 08035, Spain
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Hospital Universitari i Politecnic La Fe
RECRUITINGValencia, Valencia, 46026, Spain
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Hospital Universitario La Paz
TERMINATEDMadrid, 28046, Spain
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Hospital Universitario Ramon y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Universitario de Canarias
RECRUITINGSan Cristóbal de La Laguna, Canary Islands, 38320, Spain
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IRCCS Istituto Giannina Gaslini
TERMINATEDGenova, 16147, Italy
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IRCCS Ospedale Pediatrico Bambino Gesu
TERMINATEDRoma, 00165, Italy
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Istanbul Universitesi Cerrahpasa Tip Fakultesi
RECRUITINGIstanbul, 34098, Turkey (Türkiye)
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Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
RECRUITINGIstanbul, 34093, Turkey (Türkiye)
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John Radcliffe Hospital
RECRUITINGOxford, OX3 7LD, United Kingdom
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Landeskrankenhaus Bregenz
RECRUITINGBregenz, 6900, Austria
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Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
ACTIVE_NOT_RECRUITINGWarsaw, 02-637, Poland
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Nottingham Childrens Hospital
RECRUITINGNottingham, NG7 2UH, United Kingdom
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Ospedale Santissima Annunziata
TERMINATEDChieti, 66100, Italy
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Panorama Medical Centre
RECRUITINGPanorama, Western Cape, 7500, South Africa
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SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
ACTIVE_NOT_RECRUITINGLodz, 91-738, Poland
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Spitalul Clinic de Urgenta pentru Copii Cluj
TERMINATEDCluj-Napoca, 400124, Romania
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Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara
RECRUITINGTimișoara, 300011, Romania
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Umraniye Egitim ve Arastirma Hastanesi
RECRUITINGIstanbul, 34764, Turkey (Türkiye)
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Unidade Local de Saude de Gaia-Espinho, EPE
RECRUITINGVila Nova de Gaia, 4430-502, Portugal
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Unidade Local de Saude de Lisboa Ocidental, EPE - Hospital Egas Moniz
TERMINATEDLisbon, 1349-019, Portugal
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Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
RECRUITINGLisbon, 1649-035, Portugal
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Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao
TERMINATEDPorto, 4200-319, Portugal
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Unidade Local de Saude do Alto Minho EPE - Hospital do Conde de Bertiandos
RECRUITINGPonte de Lima, 4990-041, Portugal
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Universitaetsklinikum Dresden
TERMINATEDDresden, 01307, Germany
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Universitair Medisch Centrum Utrecht
RECRUITINGUtrecht, 3584 EA, Netherlands
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Universitair Ziekenhuis Gent
ACTIVE_NOT_RECRUITINGGhent, 9000, Belgium
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Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine
RECRUITINGVilnius, 08406, Lithuania
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Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie
ACTIVE_NOT_RECRUITINGKrakow, 31-503, Poland
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Ziekenhuis Netwerk Antwerpen Jan Palfijn
ACTIVE_NOT_RECRUITINGMerksem, 2170, Belgium