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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT04088396
• Date of registration: 11/09/2019
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIA
• Scientific title: Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis
• Date of first enrolment: February 12, 2020
• Target sample size: 103
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT04088396
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Belgium, Brazil, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Turkey, United Kingdom

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

• Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Key inclusion & exclusion 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.

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).

- 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.



Age minimum: 1 Year
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Baricitinib

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

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 in Remission [Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)]

Percentage of Participants with Minimal Disease Activity [Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)]

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: 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)]

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)]

Percentage of Participants with Inactive Disease [Time Frame: Baseline through End of DBW Period (Disease Flare or up to Week 56)]

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)]

Secondary ID(s)

16275

2017-004495-60

I4V-MC-JAHU

Source(s) of Monetary Support

Please refer to primary and secondary sponsors