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I4V-MC-JAIO: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to less than 18 Years of Age with Alopecia Areata

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502700-78-00
Acronym
I4V-MC-JAIO
Enrollment
414
Registered
2023-08-28
Start date
2023-09-01
Completion date
Unknown
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia areata (AA)

Brief summary

Percentage of participants achieving an absolute Severity of Alopecia Tool (SALT) ≤ 20

Interventions

DRUGBARICITINIB
DRUGBaricitinib
DRUGA placebo to match LY3009104

Sponsors

Eli Lilly & Co.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Percentage of participants achieving an absolute Severity of Alopecia Tool (SALT) ≤ 20—

Countries

France, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026