A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

Sponsor
Eli Lilly and Company
Study ID
NCT03952559
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally
  • Topical corticosteroid — DRUG
    Administered as standard-of-care

Study Details

The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

Key Dates

Start date
May 24, 2019
Status verified
Apr 2026
Primary completion
Apr 24, 2022
Completion
May 31, 2026

Study Design

Enrollment
516 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib Open Label High Dose (PK Lead-in)
    Participants 10 to \< 18 years received Baricitinib high dose (4 mg) administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension (1 mL) QD.
  • Experimental: Baricitinib High Dose
    Participants 10 to \< 18 years received Baricitinib high dose (4 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib high dose (2 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
  • Experimental: Baricitinib Medium Dose
    Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
  • Experimental: Baricitinib Low Dose
    Participants 10 to \< 18 years received Baricitinib low dose (1 mg) and placebo to maintain the blind, administered orally in tablet form QD. Participants 2 to \< 10 years received Baricitinib low dose (0.5 mg) administered as oral suspension QD or placebo oral suspension QD to maintain the blind.
  • Placebo Comparator: Placebo
    Participants 10 to \< 18 years received placebo tablets. Participants 2 to \< 10 years received placebo as oral suspension.

Primary Outcome Measure

Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥2 Point Improvement [ Time Frame: Week 16 ]

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