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Trial record 1 of 1 for:    NCT04088409
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088409
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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
Uveitis Drug: Baricitinib Drug: Adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 16, 2019
Estimated Primary Completion Date : November 11, 2022
Estimated Study Completion Date : December 3, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: Baricitinib
Baricitinib given orally.
Drug: Baricitinib
Administered orally
Other Name: LY3009104

Active Comparator: Adalimumab
Adalimumab given subcutaneously (SC).
Drug: Adalimumab
Administered SC




Primary Outcome Measures :
  1. Percentage of Responders [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Visual Acuity Measured by Age-Appropriate LogMAR Test

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

  6. Change from Baseline in Grade of Flare in the Anterior Chamber [ Time Frame: 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) [ Time Frame: Week 24 ]
    Percentage of Participants with Inactive Anterior Uveitis (using SUN Definition)

  8. Time to Inactive Anterior Uveitis Disease (Using SUN Definition) [ Time Frame: 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 [ Time Frame: Week 24 ]
    Percentage of Participants who are Able to Taper Concomitant Topical Corticosteroids to <2 Drops Per Day

  10. Time to Treatment Response [ Time Frame: 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) [ Time Frame: Week 24 ]
    PediACR30 Response Rate (For Participants with JIA-U)

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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088409


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04088409    
Other Study ID Numbers: 16277
I4V-MC-JAHW ( Other Identifier: Eli Lilly and Company )
2019-000119-10 ( EudraCT Number )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents