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I4V-MC-JAIP: A Phase 3, Multicenter, Randomized, Double blind, Placebo controlled, Parallel group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients with Moderate-to-Severe Atopic Dermatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503898-38-00
Acronym
I4V-MC-JAIP
Enrollment
194
Registered
2024-04-19
Start date
2019-05-24
Completion date
Unknown
Last updated
2025-08-13

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

Conditions

Atopic Dermatitis

Brief summary

1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement, 2. Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104., 3. Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104, 4. Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach

Interventions

DRUGBARICITINIB
DRUGTRIAMCINOLONE ACETONIDE
DRUGHYDROCORTISONE
DRUGBaricitinib
DRUGPlacebo to match 4 mg tablet
DRUGHydrocutan Creme 1 %
DRUGPlacebo to match 2mg tablet
DRUGPlacebo to match 1mg tablet
DRUGPlacebo to match 2mg/ml oral suspension

Sponsors

Eli Lilly & Co.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
1. Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement, 2. Open Label Population Pharmacokinetics (Pop PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) of LY3009104., 3. Open Label Pop PK: Area Under the Concentration-Time Curve for Dosing Interval at Steady State (AUCtau,ss) of LY3009104, 4. Open label Pop PK: AUCtau,ss was derived by a population pharmacokinetics approach—

Countries

Austria, Czechia, France, Germany, Hungary, Poland, Spain

Outcome results

None listed

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