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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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04088409
Collaborator
(none)
40
Enrollment
23
Locations
2
Arms
105.2
Anticipated Duration (Months)
1.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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 anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Active-Controlled, Safety, and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
Actual Study Start Date :
Oct 16, 2019
Anticipated Primary Completion Date :
Mar 10, 2023
Anticipated Study Completion Date :
Jul 21, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baricitinib

Baricitinib given orally.

Drug: Baricitinib
Administered orally
Other Names:
  • LY3009104

    		•
    Active Comparator: Adalimumab

    Adalimumab given subcutaneously (SC).

    Drug: Adalimumab
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Responders [Week 24]

      Response is defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline.

    Secondary Outcome Measures

    1. Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye [Baseline, Week 24]

      Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye

    2. Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) [Baseline, Week 24]

      Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)

    3. Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline [Week 24]

      Response is defined according to the SUN criteria as a 2-step decrease in the level of anterior chamber cells in the most severely affected eye at baseline (or both eyes if the inflammation grade is the same in both eyes) and a 1-step decrease in the level of anterior chamber cells in the less severely affected eye at baseline.

    4. Change from Baseline in Visual Acuity Measured by Age-Appropriate Logarithm of the Minimum Angle of Resolution (LogMAR) Test [Baseline, Week 24]

      Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test

    5. Change from Baseline in Vitreous Haze [Baseline, Week 24]

      Change from Baseline in Vitreous Haze

    6. Change from Baseline in Grade of Flare in the Anterior Chamber [Baseline, Week 24]

      Change from Baseline in Grade of Flare in the Anterior Chamber

    7. Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition) [Week 24]

      Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)

    8. Time to Inactive Anterior Uveitis Disease (Using SUN Definition) [Baseline through Week 24]

      Time to Inactive Anterior Uveitis Disease (Using SUN Definition)

    9. Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day [Week 24]

      Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day

    10. Time to Treatment Response [Baseline through Week 24]

      Response is defined by a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero in the most severely affected eye at baseline

    11. PediACR30 Response Rate (For Participants with JIA-U) [Week 24]

      PediACR30 Response Rate (For Participants with JIA-U)

    12. Change from Baseline in Overall Uveitis-Related Disability [Baseline, Week 24]

      Change from Baseline in Overall Uveitis-Related Disability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau Nîmes Gard France 30029
    2 Hospices Civils de Lyon - Hôpital Femme Mère Enfant Bron Rhône-Alpes France 69500
    3 Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre Le Kremlin Bicetre France 94270
    4 GH Necker - Enfants Malades Paris Cedex 15 France 75743
    5 CHU Poitiers - Hopital Jean Bernard Poitiers Cedex France 86021
    6 Asklepios Klinik Sankt Augustin Saint Augustin Nordrhein-Westfalen Germany 53757
    7 HELIOS Klinikum Berlin-Buch Berlin Germany 13125
    8 Charité Campus Virchow-Klinikum Berlin Germany 13353
    9 Hamburger Zentrum für Kinder und Jugendrheumatologie Hamburg Germany 22081
    10 Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini Genova Liguria Italy 16147
    11 Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Lombardia Italy 20122
    12 Azienda Ospedaliero Universitaria Meyer Firenze Italy 50139
    13 Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona Spain 08950
    14 Hospital Infantil Universitario Niño Jesús Madrid Madrid, Comunidad De Spain 28009
    15 Hospital Universitario La Paz Madrid Spain 28046
    16 Hospital Universitario La Fe de Valencia Valencia Spain 46026
    17 Bristol Royal Hospital for Children Bristol Bristol, City Of United Kingdom BS2 8BJ
    18 Cambridge Clinical Research Facility Cambridge Cambridgeshire United Kingdom CB2 0SP
    19 Alder Hey Children's Hospital Liverpool England United Kingdom L12 2AB
    20 Royal Victoria Infirmary Newcastle upon Tyne England United Kingdom NE1 4LP
    21 University Hospital Southampton NHS Foundation Trust Southampton Hampshire United Kingdom SO16 6YD
    22 Great Ormond Street Hospital For Children NHS Foundation Trust London United Kingdom WC1N 3JH
    23 Sheffield Children's Hospital Sheffield United Kingdom S10 2TH

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT04088409
    Other Study ID Numbers:
    • 16277
    • I4V-MC-JAHW
    • 2019-000119-10
    First Posted:
    Sep 12, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 17, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Uveitis
    Adalimumab

    Study Results

    No Results Posted as of Jun 23, 2022