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 UK 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)

IxekizumabAdalimumab

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

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)

Facility	City	Region
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 →

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Other trials for the same condition

An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis Recruiting

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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 the UK