New hope for kids with arthritis: drug trial shows promise
NCT ID NCT04527380
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests whether the drug ixekizumab is safe and effective for children with certain types of juvenile arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis). About 101 children aged 2 to 17 years will receive either ixekizumab or the standard drug adalimumab. The goal is to control disease activity and improve symptoms, but children will need to continue medication long-term.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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101 people
The number who actually took part.
- Started
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Apr 2021
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O.Universitaria Meyer
Florence, Tuscany, 50139, Italy
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Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200, Denmark
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Alder Hey Children's Hospital
Liverpool, England, L14 5AB, United Kingdom
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Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, 53757, Germany
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Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
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Bristol Royal Hospital for Children
Bristol, Bristol, City of, BS2 8BJ, United Kingdom
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CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
Mexico City, Mexico City, 06700, Mexico
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Centre d'Investigation Clinique Loc. 1
Paris, 75015, France
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Centro Medico Privado de Reumatologia Loc. 20
San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina
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Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, Lombardy, 20122, Italy
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Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
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Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, 1200, Belgium
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Dětská klinika Loc. 11
Olomouc, 779 00, Czechia
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
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H.R.U Málaga - Hospital Materno-infantil
Málaga, 29011, Spain
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Haywood Community Hospital
Stoke-on-Trent, Staffordshire, ST6 7AG, United Kingdom
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Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
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Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, 28009, Spain
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Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
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Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
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Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
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IRCCS Istituto Giannina Gaslini
Genoa, Liguria, 16147, Italy
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Instituto CAICI SRL Loc. 15
Rosario, Santa Fe Province, S2000, Argentina
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Klinika detskeho a dorostoveho lekarstvi Loc. 1
Prague, 12808, Czechia
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Klinikum Bremen-Mitte
Bremen, 28177, Germany
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Oddeleni revmatologie deti a dospelych Loc. 1
Prague, Praha 5, 150 06, Czechia
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Ostschweizer Kinderspital
Sankt Gallen, 9006, Switzerland
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Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7HE, United Kingdom
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Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, 22081, Germany
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Queen's Medical Centre, Nottingham University Hospitals
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
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RHUMATOLOGIE Loc. 1
Poitiers, Vienne, 86021, France
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Rhumatologie pediatrique et CEREMAIA Loc. 1
Le Kremlin-Bicêtre, Paris, 94270, France
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Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
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Service de consultation pédiatrique Loc. 1
Montpellier, Hérault, 34090, France
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Service rhumatologie Loc.
Bron, Auvergne-Rhône-Alpes, 69500, France
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Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
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St. Josef-Stift Sendenhorst
Sendenhorst, North Rhine-Westphalia, 48324, Germany
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UMC Utrecht - Wilhelmina Kinderziekenhuis
Utrecht, 3584 EA, Netherlands
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UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
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UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
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Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
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University of Naples Federico II
Naples, Campania, 80131, Italy
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Universitäts-Kinderspital beider Basel
Basel, Canton of Basel-City, 4031, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a biologic drug tame juvenile arthritis in kids?
- Coaching eases tough move to adult rheumatology care
- New hope for kids with joint pain: risankizumab trial launches
- New drug trial aims to control arthritis in kids
- New study checks safety of apremilast for kids with painful mouth sores and arthritis
- New hope for kids with arthritis: experimental drug enters final testing phase