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

  • End date
    Apr 24, 2028
  • participants needed
  • sponsor
    Eli Lilly and Company
Updated on 25 October 2022


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).

Condition Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
Treatment Adalimumab, Ixekizumab
Clinical Study IdentifierNCT04527380
SponsorEli Lilly and Company
Last Modified on25 October 2022


Yes No Not Sure

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
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