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

Last updated: January 6, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Joint Injuries

Psoriatic Arthritis

Treatment

Adalimumab

Ixekizumab

Clinical Study ID

NCT04527380
16694
2018-000681-10
I1F-MC-RHCG
  • Ages 2-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Participants must have active juvenile idiopathic arthritis (categories ofenthesitis related arthritis or juvenile psoriatic arthritis)

  • Participants must have weight of at least 10 kilograms (Kg), age starting at 2 yearsfor participants with juvenile psoriatic arthritis and starting at 6 years forparticipants with enthesitis related arthritis

  • Participants must have all immunizations up-to-date in agreement with currentimmunization guidelines, in the opinion of the investigator

Exclusion

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 ofthe juvenile idiopathic arthritis

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Adalimumab
Phase: 3
Study Start date:
April 13, 2021
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Instituto CAICI SRL

    Rosario, Santa Fe S2000
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Site Not Available

  • Cliniques universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région De 1200
    Belgium

    Site Not Available

  • UZ Gent-Reuma

    Gent, East Flanders 9000
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • UCL- Saint Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • University Hospital Motol

    Prague, Praha 5 150 06
    Czechia

    Site Not Available

  • Fakultni nemocnice Motol

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 12808
    Czechia

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus, Midtjylland 8200
    Denmark

    Active - Recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, Midtjylland 8200
    Denmark

    Site Not Available

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier, Hérault 34090
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Paris 94270
    France

    Site Not Available

  • Hospices Civils de Lyon - Hôpital Femme Mère Enfant

    Bron, Rhône-Alpes 69500
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Site Not Available

  • CHU Poitiers - Hopital Jean Bernard

    Poitiers Cedex, Vienne 86021
    France

    Site Not Available

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • Hôpital Arnaud de Villeneuve - CHU Montpellier

    Montpellier Cedex 5, 34295
    France

    Site Not Available

  • Hôpital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Site Not Available

  • GH Necker - Enfants Malades

    Paris Cedex 15, 75743
    France

    Site Not Available

  • Universitaetsklinikum Freiburg

    Freiburg, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Württemberg 79106
    Germany

    Site Not Available

  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

    Hamburg-Nord, Hamburg 22081
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin GmbH

    Saint Augustin, Nordrhein-Westfalen 53757
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin

    Sankt Augustin, Nordrhein-Westfalen 53757
    Germany

    Site Not Available

  • St. Josef-Stift Sendenhorst

    Sendenhorst, Nordrhein-Westfalen 48324
    Germany

    Site Not Available

  • Charité Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin Campus Buch

    Berlin, 13353
    Germany

    Site Not Available

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Active - Recruiting

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Klinikum Bremen-Mitte

    Bremen, 28177
    Germany

    Site Not Available

  • Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari

    Hamburg, 22081
    Germany

    Site Not Available

  • University of Naples Federico II

    Napoli, Campania 80131
    Italy

    Site Not Available

  • IRCCS Istituto Giannina Gaslini

    Genova, Liguria 16147
    Italy

    Site Not Available

  • Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano, Lombardia 20122
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Campania, Napoli 80131
    Italy

    Site Not Available

  • A.O.Universitaria Meyer

    Firenze, Toscana 50139
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer

    Firenze, Toscana 50139
    Italy

    Active - Recruiting

  • ASST Spedali Civili - Università degli Studi

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milano, 20122
    Italy

    Active - Recruiting

  • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

    Mexico City, Distrito Federal 06700
    Mexico

    Site Not Available

  • CREA de Guadalajara, S.C.

    Guadalajara, Jalisco 44620
    Mexico

    Site Not Available

  • Crea de Guadalajara

    Guadalajara, Jalisco 44600
    Mexico

    Site Not Available

  • Hospital Univ. "Dr. José Eleuterio González"

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Medical Care and Research SA de CV

    Merida, Yucatán 97070
    Mexico

    Site Not Available

  • Investigacion y Biomedicina de Chihuahua

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Hospital Materno Infantil

    Toluca, 50010
    Mexico

    Site Not Available

  • UMC Utrecht - Wilhelmina Kinderziekenhuis

    Utrecht, 3584 EA
    Netherlands

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [Barcelona] 08950
    Spain

    Site Not Available

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad De 28009
    Spain

    Site Not Available

  • H.R.U Málaga - Hospital Materno-infantil

    Malaga, 29011
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • Universitäts-Kinderspital beider Basel UKBB

    Basel, Basel Stadt 4056
    Switzerland

    Active - Recruiting

  • Universitäts-Kinderspital beider Basel

    Basel, Basel-Stadt 4031
    Switzerland

    Site Not Available

  • Ostschweizer Kinderspital

    Sankt Gallen, 9006
    Switzerland

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, Bristol, City Of BS2 8BJ
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital

    Liverpool, England L14 5AB
    United Kingdom

    Site Not Available

  • Queen's Medical Centre, Nottingham University Hospitals

    Nottingham, Nottinghamshire NG7 2UH
    United Kingdom

    Site Not Available

  • Oxford University Hospitals - Nuffield Orthopaedic Centre

    Oxford, Oxfordshire OX3 7HE
    United Kingdom

    Site Not Available

  • Haywood Community Hospital

    Stoke-on-Trent, Staffordshire ST6 7AG
    United Kingdom

    Site Not Available

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire ST4 6QG
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Site Not Available

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