A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JUVE-BASIS)

Lilly

Status and phase: Completed; Phase 3

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03773978

I4V-MC-JAHV (Other Identifier)

2017-004518-24 (EudraCT Number)

16276

Details and patient eligibility

About

The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.

Enrollment: 220 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
• Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).

Exclusion criteria

• Participants must not have systemic JIA, with or without active systemic features.
• Participants must not have persistent oligoarticular arthritis.
• Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups, including a placebo group

Baricitinib

Experimental group

Description:

Baricitinib was administered QD (once daily) as a 4-mg oral tablet for adolescent participants (12 to \<18 years of age) and children ≥9 years of age; and 2 mg for children \<9 years of age. Participants \<6 years of age received an oral suspension. Participants ≥6 to \<12 years old had the option of receiving an oral suspension. Participants \>12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.

Treatment:

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

Placebo matched to baricitinib was administered to participants during the DBW period.

Treatment:

Drug: Placebo