Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

NCT04804553 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20190529
• Study Type: interventional
• Target: 60
• Locations: 15 countries
• Sites: 45

Brief 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.

Conditions

Active Juvenile Psoriatic Arthritis

Keywords

Apremilast; Otezla®; Juvenile psoriatic arthritis; Inflammatory disorders

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Week 16

Secondary Outcomes (19)

• Change from Baseline in Participants Assessment of Pain at Week 16

  Baseline to Week 16

• Number of Participants who Achieve ACR Pedi 20, ACR Pedi 50, ACR Pedi 70 and ACR Pedi 90 Response at Week 16

  Baseline to Week 16

• Change from Baseline in the Physician Global Assessment (PGA) of Disease Activity at Week 16

  Baseline to Week 16

• Change from Baseline in the Assessment of Overall Well-being at Week 16

  Baseline to Week 16

• Change from Baseline in the Number of Joints with Active Arthritis at Week 16

  Baseline to Week 16

Study Arms (2)

Apremilast

EXPERIMENTAL

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.

Drug: Apremilast

Placebo to Apremilast

PLACEBO COMPARATOR

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.

Drug: Apremilast; Drug: Placebo

Interventions

Apremilast DRUG

Participants will receive apremilast orally.

Also known as: Otezla®

Apremilast; Placebo to Apremilast

Placebo DRUG

Participants will receive the matching placebo orally.

Placebo to Apremilast

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Study Sites (45)

Landeskrankenhaus Bregenz

Bregenz, 6900, Austria

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

TERMINATED

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

TERMINATED

Ziekenhuis Netwerk Antwerpen Jan Palfijn

Merksem, 2170, Belgium

TERMINATED

Hospices Civils de Lyon Hopital Femme Mere Enfant

Bron, 69677, France

RECRUITING

Hopital Jeanne de Flandre

Lille, 59037, France

RECRUITING

Charite - Universitaetsmedizin Berlin, Campus Virchow

Berlin, 13353, Germany

RECRUITING

Universitaetsklinikum Dresden

Dresden, 01307, Germany

RECRUITING

An der Schoen Klinik Hamburg Eilbek

Hamburg, 22081, Germany

RECRUITING

Asklepios Kinderklinik Sankt Augustin GmbH

Sankt Augustin, 53757, Germany

COMPLETED

Agia Sofia Children Hospital

Athens, 11527, Greece

RECRUITING

Attikon University General Hospital

Athens, 12462, Greece

RECRUITING

General Hospital of Thessaloniki Ippokrateio

Thessaloniki, 54642, Greece

RECRUITING

Ospedale Santissima Annunziata

Chieti, 66100, Italy

TERMINATED

IRCCS Istituto Giannina Gaslini

Genova, 16147, Italy

RECRUITING

Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini

Milan, 20122, Italy

RECRUITING

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

RECRUITING

Viesoji istaiga Vilniaus universiteto ligonine Santaros klinikos, Vaiku ligonine

Vilnius, 08406, Lithuania

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584 EA, Netherlands

RECRUITING

Wojewodzki Specjalistyczny Szpital Dzieciecy im sw Ludwika w Krakowie

Krakow, 31-503, Poland

TERMINATED

SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 91-738, Poland

TERMINATED

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

Warsaw, 02-637, Poland

TERMINATED

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

Lisbon, 1349-019, Portugal

RECRUITING

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

Lisbon, 1649-035, Portugal

RECRUITING

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

Ponte de Lima, 4990-041, Portugal

RECRUITING

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

Porto, 4200-319, Portugal

TERMINATED

Unidade Local de Saude de Gaia-Espinho, EPE

Vila Nova de Gaia, 4430-502, Portugal

RECRUITING

Spitalul Clinic de Urgenta pentru Copii Cluj

Cluj-Napoca, 400124, Romania

RECRUITING

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, 300011, Romania

RECRUITING

Panorama Medical Centre

Panorama, Western Cape, 7500, South Africa

RECRUITING

Groote Schuur Hospital

Cape Town, 7700, South Africa

TERMINATED

Hospital Universitario de Canarias

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

RECRUITING

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, 08950, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

TERMINATED

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Umraniye Egitim ve Arastirma Hastanesi

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

Birmingham Childrens Hospital

Birmingham, B4 6NH, United Kingdom

TERMINATED

Alder Hey Childrens Hospital

Liverpool, L12 2AP, United Kingdom

TERMINATED

Nottingham Childrens Hospital

Nottingham, NG7 2UH, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, OX3 7LD, United Kingdom

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

apremilast

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: March 17, 2022
• Primary Completion (Estimated): March 21, 2028
• Study Completion (Estimated): December 29, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

GB (4); LI (1); NL (1); ZA (2); TU (4); PL (3); RO (2); ES (6); DE (4); FR (2); BE (3); GR (3); PT (5); AU (1); IT (4)