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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Juvenile Psoriatic Arthritis, Enthesitis Related Arthritis

Intervention / Treatment
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* Drug: Ixekizumab
* Drug: Adalimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ixekizumab<br>Ixekizumab given subcutaneously (SC). | Drug: Ixekizumab<br>* Administered SC<br>* Other names: LY2439821;|
| Active Comparator: Adalimumab<br>Adalimumab given SC. Participants may have the option to switch to ixekizumab given SC during the open label extension period. | Drug: Adalimumab<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 | Percentage of Participants Achieving JIA ACR 30 | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving JIA ACR 30/50/70/90/100 | Percentage of Participants Achieving JIA ACR 30/50/70/90/100 | Week 0 up to Week 264 | 
| Change from Baseline in Psoriasis Area and Severity Index (PASI) for JPsA Participants with at Least 3% Body Surface Area (BSA) at Baseline | Change from Baseline in PASI for JPsA Participants with at Least 3% BSA at Baseline | Baseline, up to Week 264 | 
| Change from Baseline in Leeds Enthesitis Index (LEI) for Participants with Enthesitis at Baseline | Change from Baseline in LEI for Participants with Enthesitis at Baseline | Baseline, up to Week 264 | 
| Percentage of Participants with Disease Flare (Flare Defined as Worsening of ≥30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of ≥30% in No More than 1 of the Criteria) | Percentage of Participants with Disease Flare (Flare Defined as Worsening of ≥30% from Baseline in at Least 3 of the 6 JIA ACR Core Set Criteria and an Improvement of ≥30% in No More than 1 of the Criteria) | Week 0 up to Week 264 | 
| Pharmacokinetics (PK): Trough Concentrations (Ctrough) of Ixekizumab | Pharmacokinetics (PK): Ctrough of Ixekizumab | Week 16 | 
| Number of Participants with Anti-Ixekizumab Antibodies | Number of Participants with Anti-Ixekizumab Antibodies | Week 0 up to Week 264 |