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

Phase 1

Recruiting

Conditions: veitis
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: CTIS2023-505811-18-00

Lead Sponsor: Eli Lilly & Co.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 35

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.