A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

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 given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Official Title
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An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis

Conditions
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Uveitis

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features. Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX). Participants must have an inadequate response or intolerance to MTX. Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening. Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product. Exclusion Criteria: Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA, such as Crohn's disease or ulcerative colitis. Participants must not have any contraindications to adalimumab. Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib. Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant. Participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy). Participants must not have a current or recent (<4 weeks prior to baseline) infection. Participants must not have a positive test for hepatitis B virus (HBV) at screening. Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.

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: Baricitinib<br>Baricitinib given orally. | Drug: Baricitinib<br>* Administered orally<br>* Other names: LY3009104;|
| Active Comparator: Adalimumab<br>Adalimumab given subcutaneously (SC). | 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 Responders | Response is defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye | Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye | Baseline, Week 24 | 
| Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) | Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) | Baseline, Week 24 | 
| Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline | Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline. | Week 24 | 
| Change from Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test | Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test | Baseline, Week 24 | 
| Change from Baseline in Vitreous Haze | Change from Baseline in Vitreous Haze | Baseline, Week 24 | 
| Change from Baseline in Grade of Flare in the Anterior Chamber | Change from Baseline in Grade of Flare in the Anterior Chamber | Baseline, Week 24 | 
| Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition) | Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition) | Week 24 | 
| Time to Inactive Anterior Uveitis Disease (Using SUN Definition) | Time to Inactive Anterior Uveitis Disease (Using SUN Definition) | Baseline through Week 24 | 
| Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day | Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day | Week 24 | 
| Time to Treatment Response | Response is defined by a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero in the most severely affected eye at baseline | Baseline through Week 24 | 
| PediACR30 Response Rate (For Participants with JIA-U) | PediACR30 Response Rate (For Participants with JIA-U) | Week 24 | 
| Change from Baseline in Overall Uveitis-Related Disability | Change from Baseline in Overall Uveitis-Related Disability | Baseline, Week 24 |