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

Sponsor
Eli Lilly and Company
Study ID
NCT04088409
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Uveitis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 16, 2019
Status verified
Apr 2026
Primary completion
Jul 17, 2023
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Participants ≥9 to \<18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants \<9 years of age were administered 2 mg baricitinib QD. Participants \<6 years of age received an oral suspension. Participants ≥6 to \<12 years of age had the option of receiving an oral suspension. Participants \>12 years of age were supplied tablets.
  • Active Comparator: Adalimumab
    Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing \<30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.

Primary Outcome Measure

Part A: Percentage of Responders for Baricitinib at Week 24 [ Time Frame: Week 24 ]

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