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

Phase 3

• Conditions: childhood arthritis; joint inflammation in children; 10013361

• Registration Number: NL-OMON55112
• Lead Sponsor: Eli Lilly and company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

-Participants must have active juvenile idiopathic arthritis (categories of
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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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients meeting the JIA ACR 30 response criteria at Week 16</p><br>