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

  • STATUS
    Recruiting
  • End date
    Feb 10, 2025
  • participants needed
    100
  • sponsor
    Eli Lilly and Company
Updated on 22 September 2021
arthritis

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).

Details
Condition Autoimmune disease, Arthritis, Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis
Treatment Adalimumab, Ixekizumab
Clinical Study IdentifierNCT04527380
SponsorEli Lilly and Company
Last Modified on22 September 2021

Eligibility

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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