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A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

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ClinicalTrials.gov Identifier: NCT04088396
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Condition or disease Intervention/treatment Phase
Systemic Juvenile Idiopathic Arthritis Drug: Baricitinib Drug: Tocilizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 Baricitinib
Baricitinib given orally.
 Drug: Baricitinib
Administered orally
Other Name: LY3009104
Active Comparator: Cohort 1 Tocilizumab
Tocilizumab given Subcutaneously (SC).
 Drug: Tocilizumab
Administered SC
Experimental: Cohort 2 Baricitinib
Baricitinib given orally.
 Drug: Baricitinib
Administered orally
Other Name: LY3009104


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Adapted Pediatric American College of Rheumatology 30 Responder Index (PediACR30) Response Criteria at Week 12 [ Time Frame: Week 12 ]
    Percentage of Participants Achieving Adapted PediACR30 Response Criteria


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24 [ Time Frame: Week 24 ]
    Percentage of Participants Achieving Adapted PediACR30 Response Criteria

  2. Percentage of Participants with Inactive Disease [ Time Frame: Week 12 ]
    Percentage of Participants with Inactive Disease

  3. Percentage of Participants with Minimal Disease Activity [ Time Frame: Week 12 ]
    Percentage of Participants with Minimal Disease Activity

  4. Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in JADAS-27

  5. Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item [ Time Frame: Baseline, Week 24 ]
    Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item

  6. Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [ Time Frame: Baseline through Week 24 ]
    PK: Cmax, ss of Baricitinib

  7. PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [ Time Frame: Baseline through Week 24 ]
    PK: AUC, ss of Baricitinib


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years.
  • Participants must have at least 2 active joints at screening and baseline.
  • To be eligible for cohort 1, patients must be IL-6 inhibitor therapy naïve, have a minimum body weight of 10 kg and be at least 2 years old.
  • To be eligible for cohort 2 (open-label baricitinib), patients must be at least 1 year old.

Exclusion Criteria:

  • Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis.
  • Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria.
  • Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA.
  • Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis.
  • Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study.
  • Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks.
  • Participants must not have a current or recent (<4 weeks prior to baseline) clinically serious infection.
  • Participants must not have a positive test for hepatitis B virus.
  • Participants must not have evidence of active tuberculosis (TB) or untreated latent TB.
Contacts and Locations
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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): NCT04088396


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
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04088396    
Other Study ID Numbers: 16275
I4V-MC-JAHU ( Other Identifier: Eli Lilly and Company )
2017-004495-60 ( EudraCT Number )
2023-507883-38-00 ( EU Trial (CTIS) Number )
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
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://www.vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Systemic
Fever
Flare
sJIA
JIA
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases