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Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

NCT ID: NCT04804553

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2028-12-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Active Juvenile Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants will be randomized to receive apremilast or placebo in the double-blind 16 week treatment phase. Then, the participants will all receive apremilast for a further 36 weeks in the active treatment phase. The participants not continuing to receive apremilast through the Post-Trial Access Program or Open-label Extension study will then complete the 30 days safety follow-up period after the last dose of apremilast in the active treatment phase.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Apremilast

Participants will receive apremilast in the double-blind 16 week treatment phase. Then the participants will continue to receive apremilast in the active 36 weeks treatment phase.

Group Type EXPERIMENTAL

Apremilast

Intervention Type DRUG

Participants will receive apremilast orally.

Placebo to Apremilast

Participants will receive the matching placebo in the double-blind 16 week treatment phase. Then the participants will receive apremilast in the active 36 weeks treatment phase.

Group Type PLACEBO_COMPARATOR

Apremilast

Intervention Type DRUG

Participants will receive apremilast orally.

Placebo

Intervention Type DRUG

Participants will receive the matching placebo orally.

Interventions

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Apremilast

Participants will receive apremilast orally.

Intervention Type DRUG

Placebo

Participants will receive the matching placebo orally.

Intervention Type DRUG

Other Intervention Names

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Otezla®

Eligibility Criteria

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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).
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Landeskrankenhaus Bregenz

Bregenz, , Austria

Site Status RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status TERMINATED

Centre Hospitalier Regional de la Citadelle

Liège, , Belgium

Site Status TERMINATED

Ziekenhuis Netwerk Antwerpen Jan Palfijn

Merksem, , Belgium

Site Status TERMINATED

Hospices Civils de Lyon Hopital Femme Mere Enfant

Bron, , France

Site Status RECRUITING

Hopital Jeanne de Flandre

Lille, , France

Site Status RECRUITING

Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, , Germany

Site Status RECRUITING

Universitaetsklinikum Dresden

Dresden, , Germany

Site Status RECRUITING

An der Schoen Klinik Hamburg Eilbek

Hamburg, , Germany

Site Status RECRUITING

Asklepios Kinderklinik Sankt Augustin GmbH

Sankt Augustin, , Germany

Site Status COMPLETED

Agia Sofia Children Hospital

Athens, , Greece

Site Status RECRUITING

Attikon University General Hospital

Athens, , Greece

Site Status RECRUITING

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, , Greece

Site Status RECRUITING

Ospedale Santissima Annunziata

Chieti, , Italy

Site Status TERMINATED

IRCCS Istituto Giannina Gaslini

Genova, , Italy

Site Status RECRUITING

Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

Milan, , Italy

Site Status RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Site Status RECRUITING

Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine

Vilnius, , Lithuania

Site Status RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie

Krakow, , Poland

Site Status RECRUITING

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, , Poland

Site Status RECRUITING

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

Warsaw, , Poland

Site Status RECRUITING

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

Lisbon, , Portugal

Site Status RECRUITING

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

Lisbon, , Portugal

Site Status RECRUITING

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

Ponte de Lima, , Portugal

Site Status RECRUITING

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

Porto, , Portugal

Site Status TERMINATED

Unidade Local de Saude de Gaia-Espinho, EPE

Vila Nova de Gaia, , Portugal

Site Status RECRUITING

Spitalul Clinic de Urgenta pentru Copii Cluj

Cluj-Napoca, , Romania

Site Status RECRUITING

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, , Romania

Site Status RECRUITING

Panorama Medical Centre

Panorama, Western Cape, South Africa

Site Status RECRUITING

Groote Schuur Hospital

Cape Town, , South Africa

Site Status TERMINATED

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Canary Islands, Spain

Site Status RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Site Status RECRUITING

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, Spain

Site Status RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Site Status RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status TERMINATED

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Birmingham Childrens Hospital

Birmingham, , United Kingdom

Site Status TERMINATED

Alder Hey Childrens Hospital

Liverpool, , United Kingdom

Site Status TERMINATED

Nottingham Childrens Hospital

Nottingham, , United Kingdom

Site Status RECRUITING

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Countries

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Austria Belgium France Germany Greece Italy Lithuania Netherlands Poland Portugal Romania South Africa Spain Turkey (Türkiye) United Kingdom

Central Contacts

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Amgen Call Center

Role: CONTACT

[email protected]
866-572-6436

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20190529

Identifier Type: -

Identifier Source: org_study_id

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