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NCT04527380Active, not recruitingPhase 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

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
101 (actual)
First submitted
24 Aug 2020
Start date
13 Apr 2021
Primary completion date
19 Feb 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT04527380
EU CT number
2023-507184-19-00
EudraCT number
2018-000681-10

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 101
  • From 13 Apr 2021 to the primary completion date, 19 Feb 2024
  • 36 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants must not have concurrent use of biologic agents for the treatment of the juvenile idiopathic arthritis

Other illness

  • Participants must not have active or history of inflammatory bowel disease
  • Participants must not have active or latent tuberculosis
  • Participants must not have an active infection

Other

  • Participants must not have active uveitis

Who the study is looking for

  • 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

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto CAICI SRL Loc. 15
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Centro Medico Privado de Reumatologia Loc. 20
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GentBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Universitäts - Kinderspital beider Basel
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Ostschweizer Kinderspital
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Sankt GallenSwitzerlandUnknown status
University Hospital Olomouc
Coordinator of this site? Confirm its status
OlomoucCzechiaActive, not recruiting
Fakultni Nemocnice V Motole
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Prague 5CzechiaActive, not recruiting
Vseobecni Fakultni Nemocnice V Praze
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Praha 2CzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
HELIOS Klinikum Berlin Buch GmbH
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BerlinGermanyActive, not recruiting
Klinikum Bremen-Mitte gGmbH
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BremenGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
Zentrum Fuer Kinder Und Jugendrheumatologie
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HamburgGermanyActive, not recruiting
Asklepios-Klinik, Sankt Augustin GmbH
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Sankt AugustinGermanyActive, not recruiting
Aarhus Universitetshospital, Skejby
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AarhusDenmarkUnknown status
Sant Joan De Deu Barcelona Hospital
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Esplugues De LlobregatSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceActive, not recruiting
Hopital Necker Enfants Malades
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Bristol Royal Hospital for Children
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BristolUnited KingdomUnknown status
Alder Hey Children's Hospital
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LiverpoolUnited KingdomUnknown status
Queen's Medical Centre, Nottingham University Hospitals
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NottinghamUnited KingdomUnknown status
Oxford University Hospitals - Nuffield Orthopaedic Centre
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OxfordUnited KingdomUnknown status
Sheffield Children's Hospital
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SheffieldUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Haywood Community Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyActive, not recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyActive, not recruiting
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
Wilhelmina Childrens Hospital
Coordinator of this site? Confirm its status
UtrechtNetherlandsCompleted

This page is information, not medical advice. Discuss any trial with your doctor.