A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA

Study Overview
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Brief Summary
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The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA).

Official Title
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Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis

Conditions
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Systemic Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years. Participants must have at least 2 active joints at screening and baseline. Exclusion Criteria: Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis. Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria. Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA. Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis. Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study. Participants must not have biologic features of Macrophage Activation Syndrome (MAS). Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection. Participants must not have a positive test for hepatitis B virus. Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

Ages Eligible for Study
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Minimum Age: 1 Year
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib<br>Baricitinib given orally. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;|
| Placebo Comparator: Placebo<br>Placebo given orally. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Disease Flare | Time to Disease Flare | Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) | Percentage of Participants Achieving PedACR30 | Baseline through End of DBW Period (Disease Flare or up to Week 56) | 
| Percentage of Participants with Inactive Disease | Percentage of Participants with Inactive Disease | Baseline through End of DBW Period (Disease Flare or up to Week 56) | 
| Percentage of Participants with Minimal Disease Activity | Percentage of Participants with Minimal Disease Activity | Baseline through End of DBW Period (Disease Flare or up to Week 56) | 
| Percentage of Participants in Remission | Percentage of Participants in Remission | Baseline through End of DBW Period (Disease Flare or up to Week 56) | 
| Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 | Change from Baseline in JADAS-27 | Baseline, End of DBW Period (Disease Flare or up to Week 56) | 
| Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item | Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item | Baseline, End of DBW Period (Disease Flare or up to Week 56) | 
| Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) | PK: Cmax, ss of Baricitinib | Baseline through End of DBW Period (Disease Flare or up to Week 56) | 
| PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) | PK: AUC, ss of Baricitinib | Baseline through End of DBW Period (Disease Flare or up to Week 56) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic, Fever, Flare, sJIA, JIA