Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Juvenile Psoriatic Arthritis
Enthesitis Related Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2028
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04527380
Start Date
April 13 2021
End Date
April 1 2028
Last Update
June 5 2025
Active Locations (43)
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1
Instituto CAICI SRL Loc. 15
Rosario, Santa Fe Province, Argentina, S2000
2
Centro Medico Privado de Reumatologia Loc. 20
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
3
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
4
UZ Gent
Ghent, Oost-Vlaanderen, Belgium, 9000