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
NCT ID: NCT04088409
Last Updated: 2025-04-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
30 participants
INTERVENTIONAL
2019-10-16
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Baricitinib
Administered orally
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.
Adalimumab
Administered SC
Interventions
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Baricitinib
Administered orally
Adalimumab
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
2 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Universitaire Necker Enfants Malades
Paris, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Asklepios Klinik Sankt Augustin
Sankt Augustin, North Rhine-Westphalia, Germany
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Charité Campus Virchow-Klinikum
Berlin, , Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, , Germany
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Meyer
Florence, , Italy
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Bristol Royal Hospital for Children
Bristol, Bristol, City of, United Kingdom
Cambridge Clinical Research Facility
Cambridge, Cambridgeshire, United Kingdom
Alder Hey Children's Hospital
Liverpool, England, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, England, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Countries
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References
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Ramanan AV, Guly CM, Keller SY, Schlichting DE, de Bono S, Liao R, Quartier P. Clinical effectiveness and safety of baricitinib for the treatment of juvenile idiopathic arthritis-associated uveitis or chronic anterior antinuclear antibody-positive uveitis: study protocol for an open-label, adalimumab active-controlled phase 3 clinical trial (JUVE-BRIGHT). Trials. 2021 Oct 9;22(1):689. doi: 10.1186/s13063-021-05651-5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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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
Other Identifiers
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I4V-MC-JAHW
Identifier Type: OTHER
Identifier Source: secondary_id
2019-000119-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16277
Identifier Type: -
Identifier Source: org_study_id
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