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
NCT ID: NCT04527380
Last Updated: 2025-06-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
101 participants
INTERVENTIONAL
2021-04-13
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ixekizumab - OLT Period
Participants received subcutaneous (SC) ixekizumab from week 0 to week 16, following dosing regimens based on body weight:
* Greater than (\>) 50.0 kg: Starting dose 160 mg at week 0, then 80 mg SC every 4 weeks (Q4W) from week 2 to week 16.
* 25.0-50.0 kg: Starting dose 80 mg at week 0, then 40 mg SC Q4W from week 2 to week 16.
* 10.0 to less than (\<) 25.0 kg: Starting dose 40 mg at week 0, then 20 mg SC Q4W from week 2 to week 16.
Ixekizumab
Administered SC
Adalimumab - OLT Period
Participants received SC adalimumab from week 0 to week 16, following dosing regimens based on body weight:
* Greater than or equal to (≥) 30.0 kg: 40 mg SC every 2 weeks (Q2W).
* 10.0 to \<30.0 kg: 20 mg SC Q2W.
Adalimumab
Administered SC
Interventions
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Ixekizumab
Administered SC
Adalimumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
2 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Napoli, 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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
Other Identifiers
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I1F-MC-RHCG
Identifier Type: OTHER
Identifier Source: secondary_id
2018-000681-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507184-19-00
Identifier Type: CTIS
Identifier Source: secondary_id
16694
Identifier Type: -
Identifier Source: org_study_id
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