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New hope for kids with psoriatic arthritis: apremilast trial begins

NCT ID NCT04804553

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

5 to 17 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    25 sites in 13 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Agia Sofia Children Hospital

    RECRUITING

    Athens, 11527, Greece

  • Alder Hey Childrens Hospital

    TERMINATED

    Liverpool, L12 2AP, United Kingdom

  • An der Schoen Klinik Hamburg Eilbek

    TERMINATED

    Hamburg, 22081, Germany

  • Asklepios Kinderklinik Sankt Augustin GmbH

    TERMINATED

    Sankt Augustin, 53757, Germany

  • Attikon University General Hospital

    TERMINATED

    Athens, 12462, Greece

  • Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

    RECRUITING

    Milan, 20122, Italy

  • Birmingham Childrens Hospital

    TERMINATED

    Birmingham, B4 6NH, United Kingdom

  • Centre Hospitalier Regional de la Citadelle

    ACTIVE_NOT_RECRUITING

    Liège, 4000, Belgium

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    RECRUITING

    Berlin, 13353, Germany

  • General Hospital of Thessaloniki Ippokrateio

    RECRUITING

    Thessaloniki, 54642, Greece

  • Groote Schuur Hospital

    TERMINATED

    Cape Town, 7700, South Africa

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Hopital Jeanne de Flandre

    RECRUITING

    Lille, 59037, France

  • Hospices Civils de Lyon Hopital Femme Mere Enfant

    RECRUITING

    Bron, 69677, France

  • Hospital Sant Joan de Deu

    RECRUITING

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario La Paz

    TERMINATED

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario de Canarias

    RECRUITING

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

  • IRCCS Istituto Giannina Gaslini

    TERMINATED

    Genova, 16147, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesu

    TERMINATED

    Roma, 00165, Italy

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 7LD, United Kingdom

  • Landeskrankenhaus Bregenz

    RECRUITING

    Bregenz, 6900, Austria

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

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-637, Poland

  • Nottingham Childrens Hospital

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Ospedale Santissima Annunziata

    TERMINATED

    Chieti, 66100, Italy

  • Panorama Medical Centre

    RECRUITING

    Panorama, Western Cape, 7500, South Africa

  • SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    ACTIVE_NOT_RECRUITING

    Lodz, 91-738, Poland

  • Spitalul Clinic de Urgenta pentru Copii Cluj

    TERMINATED

    Cluj-Napoca, 400124, Romania

  • Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

    RECRUITING

    Timișoara, 300011, Romania

  • Umraniye Egitim ve Arastirma Hastanesi

    RECRUITING

    Istanbul, 34764, Turkey (Türkiye)

  • Unidade Local de Saude de Gaia-Espinho, EPE

    RECRUITING

    Vila Nova de Gaia, 4430-502, Portugal

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

    TERMINATED

    Lisbon, 1349-019, Portugal

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

    RECRUITING

    Lisbon, 1649-035, Portugal

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

    TERMINATED

    Porto, 4200-319, Portugal

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

    RECRUITING

    Ponte de Lima, 4990-041, Portugal

  • Universitaetsklinikum Dresden

    TERMINATED

    Dresden, 01307, Germany

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584 EA, Netherlands

  • Universitair Ziekenhuis Gent

    ACTIVE_NOT_RECRUITING

    Ghent, 9000, Belgium

  • Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine

    RECRUITING

    Vilnius, 08406, Lithuania

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie

    ACTIVE_NOT_RECRUITING

    Krakow, 31-503, Poland

  • Ziekenhuis Netwerk Antwerpen Jan Palfijn

    ACTIVE_NOT_RECRUITING

    Merksem, 2170, Belgium