Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Uveitis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
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 anter...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04088409
Start Date
October 16 2019
End Date
July 1 2028
Last Update
April 20 2025
Active Locations (20)
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1
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
2
Hôpital Universitaire Necker Enfants Malades
Paris, France, 75015
3
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86021
4
Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, Germany, 53757