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

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

Tracking Information

• First Submitted Date: September 11, 2019
• First Posted Date: September 12, 2019
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: February 12, 2020
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2024)

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

Original Primary Outcome Measures (submitted: September 11, 2019)

Time to Disease Flare [ Time Frame: Week 24 to End of Double Blind Withdrawal (DBW) Period (Disease Flare or up to Week 56) ]

Time to Disease Flare

Current Secondary Outcome Measures (submitted: May 7, 2024)

• Percentage of Participants Achieving Adapted PediACR30 Response Criteria at Week 24 [ Time Frame: Week 24 ]
  Percentage of Participants Achieving Adapted PediACR30 Response Criteria
• Percentage of Participants with Inactive Disease [ Time Frame: Week 12 ]
  Percentage of Participants with Inactive Disease
• Percentage of Participants with Minimal Disease Activity [ Time Frame: Week 12 ]
  Percentage of Participants with Minimal Disease Activity
• Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [ Time Frame: Baseline, Week 24 ]
  Change from Baseline in JADAS-27
• 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
• Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [ Time Frame: Baseline through Week 24 ]
  PK: Cmax, ss of Baricitinib
• PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [ Time Frame: Baseline through Week 24 ]
  PK: AUC, ss of Baricitinib

Original Secondary Outcome Measures (submitted: September 11, 2019)

• Percentage of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
  Percentage of Participants Achieving PedACR30
• Percentage of Participants with Inactive Disease [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
  Percentage of Participants with Inactive Disease
• Percentage of Participants with Minimal Disease Activity [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
  Percentage of Participants with Minimal Disease Activity
• Percentage of Participants in Remission [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
  Percentage of Participants in Remission
• Change from Baseline in Juvenile Arthritis Disease Activity Score (JADAS)-27 [ Time Frame: Baseline, End of DBW Period (Disease Flare or up to Week 56) ]
  Change from Baseline in JADAS-27
• 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, End of DBW Period (Disease Flare or up to Week 56) ]
  Change from Baseline in Arthritis-Related Pain Severity as Measured by the CHAQ Pain VAS Item
• Pharmacokinetics (PK): Maximum Plasma Baricitinib Concentration at Steady-State (Cmax, ss) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
  PK: Cmax, ss of Baricitinib
• PK: Area Under the Baricitinib Concentration-Time Curve at Steady-State (AUC, ss) [ Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56) ]
  PK: AUC, ss of Baricitinib

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Systemic Juvenile Idiopathic Arthritis

Intervention

• Drug: Baricitinib
  Administered orally
  Other Name: LY3009104
• Drug: Tocilizumab
  Administered SC

Study Arms

• Experimental: Cohort 1 Baricitinib
  Baricitinib given orally.
  Intervention: Drug: Baricitinib
• Active Comparator: Cohort 1 Tocilizumab
  Tocilizumab given Subcutaneously (SC).
  Intervention: Drug: Tocilizumab
• Experimental: Cohort 2 Baricitinib
  Baricitinib given orally.
  Intervention: Drug: Baricitinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 7, 2024): 58
• Original Estimated Enrollment (submitted: September 11, 2019): 103
• Estimated Study Completion Date: October 2025
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Argentina, Austria, Belgium, Brazil, Czechia, Denmark, France, India, Israel, Italy, Japan, Mexico, Poland, Spain, Turkey, United Kingdom
• Removed Location Countries: Germany, Russian Federation

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Eli Lilly and Company
• Verification Date: May 2024