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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
Sponsor: Eli Lilly and Company
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).
Official title: Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2021-04-13
Completion Date
2028-04
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
Ixekizumab
Administered SC
Adalimumab
Administered SC
Locations (43)
Instituto CAICI SRL Loc. 15
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia Loc. 20
San Miguel de Tucumán, Tucumán Province, Argentina
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Oddeleni revmatologie deti a dospelych Loc. 1
Prague, Praha 5, Czechia
Dětská klinika Loc. 11
Olomouc, Czechia
Klinika detskeho a dorostoveho lekarstvi Loc. 1
Prague, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, Denmark
Service rhumatologie Loc.
Bron, Auvergne-Rhône-Alpes, France
Service de consultation pédiatrique Loc. 1
Montpellier, Hérault, France
Rhumatologie pediatrique et CEREMAIA Loc. 1
Le Kremlin-Bicêtre, Paris, France
RHUMATOLOGIE Loc. 1
Poitiers, Vienne, France
Centre d'Investigation Clinique Loc. 1
Paris, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, Germany
St. Josef-Stift Sendenhorst
Sendenhorst, North Rhine-Westphalia, Germany
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, Italy
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, Lombardy, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
A.O.Universitaria Meyer
Florence, Tuscany, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Mexico City, Mexico
UMC Utrecht - Wilhelmina Kinderziekenhuis
Utrecht, Netherlands
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, Spain
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, Switzerland
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
Bristol Royal Hospital for Children
Bristol, Bristol, City of, United Kingdom
Alder Hey Children's Hospital
Liverpool, England, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
Nottingham, Nottinghamshire, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, Oxfordshire, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Haywood Community Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom