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Recruiting Phase 3 NCT03773965

NCT03773965 A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis

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Clinical Trial Summary
NCT ID NCT03773965
Status Recruiting
Phase Phase 3
Sponsor Eli Lilly and Company
Condition Juvenile Idiopathic Arthritis
Study Type INTERVENTIONAL
Enrollment 190 participants
Start Date 2019-04-05
Primary Completion 2031-07

Eligibility & Interventions

Sex All sexes
Min Age 1 Year
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
Baricitinib

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 190 participants in total. It began in 2019-04-05 with a primary completion date of 2031-07.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.

Eligibility Criteria

Inclusion Criteria: * Participants must have completed a previous study of baricitinib for the treatment of JIA. Exclusion Criteria: * Participants must not have had a permanent discontinuation of baricitinib in the prior study. * Participants must have not developed an allergy to baricitinib.

Contact & Investigator

Central Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

✉ LillyTrials@Lilly.com

📞 1-317-615-4559

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST

STUDY DIRECTOR

Eli Lilly and Company

Frequently Asked Questions

Who can join the NCT03773965 clinical trial?

This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Juvenile Idiopathic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT03773965 trial and what does that mean for participants?

Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 190 participants.

Is NCT03773965 currently recruiting?

Yes, NCT03773965 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.

Where is the NCT03773965 trial being conducted?

This trial is being conducted at Rosario, Argentina, SAN M. de Tucuman, Argentina, Melbourne, Australia, Perth, Australia and 11 additional locations.

Who is sponsoring the NCT03773965 clinical trial?

NCT03773965 is sponsored by Eli Lilly and Company. The principal investigator is Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST at Eli Lilly and Company. The trial plans to enroll 190 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology