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Clinical Trials in Italy / NCT04527380
Active, not recruiting Phase 3

A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

NCT04527380 · tracked via the Priya Life Science Italy tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2021-04-13
Last updated
2026-08-12

Condition(s) studied

Juvenile Psoriatic ArthritisEnthesitis Related Arthritis

Investigational drug(s) / intervention(s)

Ixekizumab →Adalimumab →

Ixekizumab: Administered SC

Adalimumab: Administered SC

Study summary

The reason for this study is to see if the study drug ixekizumab is safe and effective in children with juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) (including juvenile onset ankylosing spondylitis \[JoAS\]) and juvenile psoriatic arthritis (JPsA).

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * Participants must have active juvenile idiopathic arthritis (categories of enthesitis related arthritis or juvenile psoriatic arthritis) * Participants must have weight of at least 10 kilograms (Kg), age starting at 2 years for participants with juvenile psoriatic arthritis and starting at 6 years for participants with enthesitis related arthritis * Participants must have all immunizations up-to-date in agreement with current immunization guidelines, in the opinion of the investigator Exclusion Criteria: * Participants must not have active or history of inflammatory bowel disease * Participants must not have active uveitis * Participants must not have active or latent tuberculosis * Participants must not have an active infection * Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis

Primary outcome measure(s)

  • Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (Ixekizumab - OLT Period) — Week 16
    JIA ACR, is comprised of 6 variables: number of active joints, number of joints with limited range of motion, Physician's Global Assessment of Disease Activity, Parent's Global Assessment of Well-Being, physical function (measured by the Childhood Health Assessment Questionnaire \[CHAQ\]), and acute-phase reactants (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]). A JIA ACR30 response is defined as at least 30% improvement from baseline in at least 3 of any 6 variables in the core set, with no more than 1 of the remaining variables worsening by more than 30%.

Trial sites (43)

FacilityCityRegionStatus
Instituto CAICI SRL Loc. 15 Rosario Santa Fe Province
Centro Medico Privado de Reumatologia Loc. 20 San Miguel de Tucumán Tucumán Province
Cliniques universitaires Saint-Luc Brussels Bruxelles-Capitale, Région de
UZ Gent Ghent Oost-Vlaanderen
UZ Leuven Leuven Vlaams-Brabant
Oddeleni revmatologie deti a dospelych Loc. 1 Prague Praha 5
Dětská klinika Loc. 11 Olomouc Czechia
Klinika detskeho a dorostoveho lekarstvi Loc. 1 Prague Czechia
Aarhus Universitetshospital, Skejby Aarhus Central Jutland
Service rhumatologie Loc. Bron Auvergne-Rhône-Alpes
Service de consultation pédiatrique Loc. 1 Montpellier Hérault
Rhumatologie pediatrique et CEREMAIA Loc. 1 Le Kremlin-Bicêtre Paris
RHUMATOLOGIE Loc. 1 Poitiers Vienne
Centre d'Investigation Clinique Loc. 1 Paris France
Universitaetsklinikum Freiburg Freiburg im Breisgau Baden-Wurttemberg
Asklepios Klinik Sankt Augustin Sankt Augustin North Rhine-Westphalia
St. Josef-Stift Sendenhorst Sendenhorst North Rhine-Westphalia
Helios Klinikum Berlin-Buch Berlin Germany
Charité Campus Virchow-Klinikum Berlin Germany
Klinikum Bremen-Mitte Bremen Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari Hamburg Germany
University of Naples Federico II Naples Campania
IRCCS Istituto Giannina Gaslini Genoa Liguria
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO Milan Lombardy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Lombardy
A.O.Universitaria Meyer Florence Tuscany
Azienda Ospedaliera Spedali Civili di Brescia Brescia Italy
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas Mexico City Mexico City
UMC Utrecht - Wilhelmina Kinderziekenhuis Utrecht Netherlands
Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona [Barcelona]
Hospital Infantil Universitario Niño Jesús Madrid Madrid, Comunidad de
H.R.U Málaga - Hospital Materno-infantil Málaga Spain
Hospital Universitario Virgen Del Rocio Seville Spain
Hospital Universitari i Politecnic La Fe Valencia Spain
Universitäts-Kinderspital beider Basel Basel Canton of Basel-City
Ostschweizer Kinderspital Sankt Gallen Switzerland
Bristol Royal Hospital for Children Bristol Bristol, City of
Alder Hey Children's Hospital Liverpool England
Queen's Medical Centre, Nottingham University Hospitals Nottingham Nottinghamshire
Oxford University Hospitals - Nuffield Orthopaedic Centre Oxford Oxfordshire

+ 3 more sites — see the full list on the official registry below.

On this site

📄 Taltz (ixekizumab) drug profile → 📄 Humira (adalimumab) drug profile →

More Eli Lilly and Company trials in Italy

A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer Active, not recruiting
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer Active, not recruiting
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer Active, not recruiting

Other trials for the same condition

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab Recruiting
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04527380 on ClinicalTrials.gov ↗ ← All trials in Italy