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

• Status: Recruiting
• Trial end date: 2023-08-07
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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 arthritis in 1 or more joints with or preceded by fever of at least 2 weeks' duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following:

• Evanescent (nonfixed) erythematous rash

• Generalized lymph node enlargement

• Hepatomegaly and/or splenomegaly

• Serositis

• 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, such as Crohn's disease or ulcerative colitis.

• 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.