Juvenile Psoriatic Arthritis Clinical Trial
Official title:
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
Verified date | March 2024 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 100 |
Est. completion date | April 24, 2028 |
Est. primary completion date | February 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques universitaires Saint-Luc | Brussels | Bruxelles-Capitale, Région De |
Belgium | UZ Gent | Gent | Oost-Vlaanderen |
Belgium | UZ Leuven | Leuven | Vlaams-Brabant |
Denmark | Aarhus Universitetshospital, Skejby | Aarhus | Midtjylland |
Germany | Charité Campus Virchow-Klinikum | Berlin | |
Germany | Helios Klinikum Berlin-Buch | Berlin | |
Germany | Klinikum Bremen-Mitte | Bremen | |
Germany | Universitaetsklinikum Freiburg | Freiburg | Baden-Württemberg |
Germany | Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari | Hamburg | |
Germany | Asklepios Klinik Sankt Augustin | Sankt Augustin | Nordrhein-Westfalen |
Germany | St. Josef-Stift Sendenhorst | Sendenhorst | Nordrhein-Westfalen |
Italy | Azienda Ospedaliera Spedali Civili di Brescia | Brescia | |
Italy | A.O.Universitaria Meyer | Firenze | Toscana |
Italy | IRCCS Istituto Giannina Gaslini | Genova | Liguria |
Italy | Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO | Milano | Lombardia |
Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milano | Lombardia |
Italy | University of Naples Federico II | Napoli | Campania |
Mexico | CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas | Mexico City | Distrito Federal |
Netherlands | UMC Utrecht - Wilhelmina Kinderziekenhuis | Utrecht | |
Spain | 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 | Malaga | |
Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
Spain | Hospital Universitari i Politecnic La Fe | València | |
Switzerland | Universitäts-Kinderspital beider Basel | Basel | Basel-Stadt |
Switzerland | Ostschweizer Kinderspital | Sankt Gallen | |
United Kingdom | 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 | Sheffield Children's Hospital | Sheffield | |
United Kingdom | Haywood Community Hospital | Stoke-on-Trent | Staffordshire |
United Kingdom | Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Belgium, Denmark, Germany, Italy, Mexico, Netherlands, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 | Percentage of Participants Achieving JIA ACR 30 | Week 16 | |
Secondary | Percentage of Participants Achieving JIA ACR 30/50/70/90/100 | Percentage of Participants Achieving JIA ACR 30/50/70/90/100 | Week 0 up to Week 264 | |
Secondary | Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline | Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline | Baseline, up to Week 264 | |
Secondary | Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline | Change from Baseline in LEI for Participants with Enthesitis at Baseline | Baseline, up to Week 264 | |
Secondary | Percentage of Participants with Disease Flare (Flare Defined as Worsening of =30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of =30% in No More than 1 of the Criteria) | Percentage of Participants with Disease Flare (Flare Defined as Worsening of =30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of =30% in No More than 1 of the Criteria) | Week 0 up to Week 264 | |
Secondary | Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab | Pharmacokinetics (PK): Ctrough of Ixekizumab | Week 16 | |
Secondary | Number of Participants with Anti-Ixekizumab Antibodies | Number of Participants with Anti-Ixekizumab Antibodies | Week 0 up to Week 264 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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