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
- Conditions
- Juvenile Psoriatic ArthritisEnthesitis Related Arthritis
- Interventions
- Registration Number
- NCT04527380
- Lead Sponsor
- Eli Lilly and Company
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ixekizumab Ixekizumab Ixekizumab given subcutaneously (SC). Adalimumab Adalimumab Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Week 16 Percentage of Participants Achieving JIA ACR 30
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving JIA ACR 30/50/70/90/100 Week 0 up to Week 264 Percentage of Participants Achieving JIA ACR 30/50/70/90/100
Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline Baseline, up to Week 264 Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline
Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline Baseline, up to Week 264 Change from Baseline in LEI for Participants with Enthesitis at Baseline
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 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)
Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab Week 16 Pharmacokinetics (PK): Ctrough of Ixekizumab
Number of Participants with Anti-Ixekizumab Antibodies Week 0 up to Week 264 Number of Participants with Anti-Ixekizumab Antibodies
Trial Locations
- Locations (33)
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, England, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
🇬🇧Oxford, Oxfordshire, United Kingdom
Universitäts-Kinderspital beider Basel
🇨🇭Basel, Basel-Stadt, Switzerland
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Klinikum Bremen-Mitte
🇩🇪Bremen, Germany
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Bruxelles-Capitale, Région De, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Helios Klinikum Berlin-Buch
🇩🇪Berlin, Germany
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium
Asklepios Klinik Sankt Augustin
🇩🇪Sankt Augustin, Nordrhein-Westfalen, Germany
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
St. Josef-Stift Sendenhorst
🇩🇪Sendenhorst, Nordrhein-Westfalen, Germany
Charité Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
University of Naples Federico II
🇮🇹Napoli, Campania, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
🇮🇹Milano, Lombardia, Italy
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
🇩🇪Hamburg, Germany
IRCCS Istituto Giannina Gaslini
🇮🇹Genova, Liguria, Italy
A.O.Universitaria Meyer
🇮🇹Firenze, Toscana, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
UMC Utrecht - Wilhelmina Kinderziekenhuis
🇳🇱Utrecht, Netherlands
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas
🇲🇽Mexico City, Distrito Federal, Mexico
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
Ostschweizer Kinderspital
🇨🇭Sankt Gallen, Switzerland
Bristol Royal Hospital for Children
🇬🇧Bristol, Bristol, City Of, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom
Haywood Community Hospital
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
🇬🇧Nottingham, Nottinghamshire, United Kingdom