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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
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

NCT04527380

Active Not RecruitingPhase 3

Sponsor: Eli Lilly and Company

Conditions: Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

Interventions: Ixekizumab, Adalimumab

Countries: Argentina, Belgium, Czechia, Denmark, France, Germany, Italy, Mexico

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 overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (43)
  • Rosario, Santa Fe Province, Argentina
  • San Miguel de Tucumán, Tucumán Province, Argentina
  • Brussels, Bruxelles-Capitale, Région de, Belgium
  • Ghent, Oost-Vlaanderen, Belgium
  • Leuven, Vlaams-Brabant, Belgium
  • Prague, Praha 5, Czechia
  • Olomouc, Czechia
  • Prague, Czechia
  • Aarhus, Central Jutland, Denmark
  • Bron, Auvergne-Rhône-Alpes, France
  • Montpellier, Hérault, France
  • Le Kremlin-Bicêtre, Paris, France
  • Poitiers, Vienne, France
  • Paris, France
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Sankt Augustin, North Rhine-Westphalia, Germany
  • Sendenhorst, North Rhine-Westphalia, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Bremen, Germany
  • Hamburg, Germany
  • Naples, Campania, Italy
  • Genoa, Liguria, Italy
  • Milan, Lombardy, Italy
  • Milan, Lombardy, Italy
  • Florence, Tuscany, Italy
  • Brescia, Italy
  • Mexico City, Mexico City, Mexico
  • Utrecht, Netherlands
  • Esplugues de Llobregat, Barcelona [Barcelona], Spain
  • + 13 more on CT.gov